Other substances

GC376

A 3C-like protease dipeptidyl inhibitor.

Phase of research

Potential treatment - pre-clinical evidence

How it helps

Antiviral

Drug status

Experimental

12
 Supporting references
0
 Contradictory references
32
 AI-suggested references
40
 Clinical trials

General information

GC376 is a synthetic 3C-like protease inhibitor active against a feline corona virus causing infectious peritonitis (Pedersen et al., 2018). It was also shown to inhibit SARS-CoV-2 3C-like protease in vitro (Ma et al., 2020, Shi et al., 2021) and thus likely acts dually, combined with cathepsin L inhibition, against SARS-CoV-2 infection (Hu et al., 2021). Its in vivo anti-SARS-CoV-2 activity in a murine model, when used in a monotherapy, was limited, however (Shi et al., 2021).

GC376 on PubChem
GC376 on Wikipedia

Synonyms

GC-376; sodium;(2S)-1-hydroxy-2-[[(2S)-4-methyl-2-(phenylmethoxycarbonylamino)pentanoyl]amino]-3-(2-oxopyrrolidin-3-yl)propane-1-sulfonate

 

Structure image - GC376

CC(C)C[C@@H](C(=O)N[C@@H](CC1CCNC1=O)C(O)S(=O)(=O)[O-])NC(=O)OCC2=CC=CC=C2.[Na+]

Supporting references

Link Tested on Impact factor Notes Publication date
Boceprevir, GC-376, and calpain inhibitors II, XII inhibit SARS-CoV-2 viral replication by targeting the viral main protease
3CLpro Crystallization Small molecule Enzyme assay In vitro 		in vitro enzyme assay; crystallization; Vero 76 cells; SARS-CoV-2 strain USA-WA1/2020 20.51

Inhibited SARS-CoV-2 3C-like protease with an IC50 of ca. 0.03 μM in vitro.

Inhibited SARS-CoV-2 infection in primary CPE assay with an EC50 of ca. 3.37 μM and an SI of >29.7.

 Jun/15/2020
Feline coronavirus drug inhibits the main protease of SARS-CoV-2 and blocks virus replication
3CLpro Small molecule Enzyme assay In vitro 		VERO E6 cell cultures 12.12

Effectively inhibit the SARS-CoV-2 3C-like protease in vitro and inhibit SARS-CoV-2 in cell culture.

 Aug/27/2020
Structure Basis for Inhibition of SARS-CoV-2 by the Feline Drug GC376
Preprint 		VERO E6 cell cultures Jun/08/2020
Both Boceprevir and GC376 efficaciously inhibit SARS-CoV-2 by targeting its main protease
3CLpro Small molecule Enzyme assay In vitro 		Vero cells; enzyme assay 12.12

Inhibit SARS-CoV-2 3C-like protease in vitro via catalytically active site binding. Additive antiviral effect in combination with Remdesivir.

 Sep/04/2020
Evaluation of SARS-CoV-2 3C-like protease inhibitors using self-assembled monolayer desorption ionization mass spectrometry
3CLpro Small molecule Enzyme assay In vitro 		in vitro enzyme assay; Vero E6 cells; MRC-5 human lung fibrobrast cells; HeLa cells 4.10

Manifests strong inhibitory activity on the SARS-CoV-2 3C-like protease at non-cytotoxic concentrations.

 Sep/05/2020
Development of a Cell-Based Luciferase Complementation Assay for Identification of SARS-CoV-2 3CLpro Inhibitors
3CLpro Small molecule Enzyme assay In vitro 		in vitro enzyme assay 3.82

The compound inhibited the SARS-CoV-2 3C-like protease in vitro with EC50 of 23.8 μM and CC50 of >100 μM.

 Jan/24/2021
Dual inhibition of SARS-CoV-2 and human rhinovirus with protease inhibitors in clinical development
3CLpro Cathepsin L Small molecule Enzyme assay In vitro 		in vitro enzyme assay 4.10

The compound inhibited the SARS-CoV-2 3C-like protease with IC50 of 13 nM and human cathepsin L with IC50 of 0.33 nM in vitro.

 Jan/27/2021
A comparative analysis of SARS-CoV-2 antivirals characterizes 3CLpro inhibitor PF-00835231 as a potential new treatment for COVID-19
3CLpro Small molecule In vitro 		ACE2-expressing A549 cells; polarized human airway epithelia cultures; SARS-CoV-2 strain USA-WA1/2020; SARS-CoV-2 isolate USA/NYU-VC-003/2020 4.50

The drug inhibited infection by SARS-CoV-2 isolates in a human epithelial cell line with sub-micromolar EC50s, which were similar or slightly higher than those of PF-00835231.

 Feb/23/2021
Boceprevir, Calpain Inhibitors II and XII, and GC-376 Have Broad-Spectrum Antiviral Activity against Coronaviruses
Biophysical assay Cathepsin L Enzyme assay In vitro Mechanism 		in vitro enzyme assay; in vitro biophysical assay; Vero cells; Caco-2 cells; (HIV-1) SARS-CoV-2 Spike pseudovirus 4.61

The compound inhibited cathepsin L in vitro with an IC50 of 0.99 nM. It neutralized SARS-CoV-2 pseudovirus in vitro only in the presence of 2 μM CP-100356 (an efflux pump inhibitor), but the inhibition was potent, with an IC50 of ca. 1.07 μM. The compound also inhibited SARS-CoV-2 replication in Caco-2 cells with an EC50 of ca. 2.58 μM and low cytotoxicity (CC50 >100 μM).

 Mar/01/2021
The preclinical inhibitor GS441524 in combination with GC376 efficaciously inhibited the proliferation of SARS-CoV-2 in the mouse respiratory tract
RdRpol Crystallization Small molecule Animal model In vitro 		crystallization; Vero E6 cells; Sprague Dawley rats (pharmacokinetics only); specific pathogen-free mice (toxicity); BALB/c mice; mouse-adapted SARS-CoV-2 (HRB26M); SARS-CoV-2 (HRB26) 5.78

The compound was not cytotoxic. Although even high dose GC376 monotherapy had only limited inhibitory effect on (mouse-adapted) SARS-CoV-2 infection in mice (despite an EC50 of ca. 0.643 μM or 0.881 μM in Vero E6 cells for a human and a mouse-adapted version, respectively, and observed covalent bond between the drug and RNA-dependent RNA polymerase in a crystal structure), low-dose combined therapy together with GS-441524 provided synergistic effect. This reflected the observation of the co-treatment EC50 values of ca. 0.531 μM and 0.369 μM in Vero E6 cells for a human and a mouse-adapted version, respectively. Co-administration of the drugs is supported by pharmacokinetics observations.

 Mar/19/2021
Lead compounds for the development of SARS-CoV-2 3CL protease inhibitors
3CLpro Crystallization Enzyme assay In vitro In silico 		in silico; in vitro enzyme assay; crystallization; Vero E6 cells; SARS-CoV-2 strain 2019-nCoV/USA_WA1/2020 12.12

The compound inhibited SARS-CoV-2 3C-like protease with an IC50 of ca. 160 nM in an enzyme assay and displayed efficacy against SARS-CoV-2 infection in Vero E6 cells with an EC50 of ca. 2.2 μM.

 Apr/01/2021
Inhibitors of coronavirus 3CL proteases protect cells from protease-mediated cytotoxicity
3CLpro Small molecule In vitro 		HEK293T cells expressing SARS-CoV-2 3C-like protease 4.50

The compound inhibited SARS-CoV-2 3C-like protease with an EC50 of 0.98 µM in vitro.

 Apr/28/2021

AI-suggested references

Link Publication date
Virtual screening of natural products inspired in-house library to discover potential lead molecules against the SARS-CoV-2 main protease.
Nov/30/2020
Mechanistic Insights into SARS-CoV-2 Main Protease Inhibition Reveals Hotspot Residues.
Nov/29/2021
A Structural Comparison of SARS-CoV-2 Main Protease and Animal Coronaviral Main Protease Reveals Species-Specific Ligand Binding and Dimerization Mechanism.
May/18/2022
In Silico and In Vitro Identification of Pan-Coronaviral Main Protease Inhibitors from a Large Natural Product Library
Mar/15/2022
Postinfection treatment with a protease inhibitor increases survival of mice with a fatal SARS-CoV-2 infection
Nov/12/2020
MPI8 is Potent against SARS-CoV-2 by Inhibiting Dually and Selectively the SARS-CoV-2 Main Protease and the Host Cathepsin L**
Jul/29/2021
Repurposing of Some Natural Product Isolates as SARS-COV-2 Main Protease Inhibitors via In Vitro Cell Free and Cell-Based Antiviral Assessments and Molecular Modeling Approaches.
Mar/04/2021
Neoechinulin A as a Promising SARS-CoV-2 Mpro Inhibitor: In Vitro and In Silico Study Showing the Ability of Simulations in Discerning Active from Inactive Enzyme Inhibitors
Apr/16/2022
Modulation of the monomer-dimer equilibrium and catalytic activity of SARS-CoV-2 main protease by a transition-state analog inhibitor
Mar/01/2022
Rational Design of Hybrid SARS-CoV-2 Main Protease Inhibitors Guided by the Superimposed Cocrystal Structures with the Peptidomimetic Inhibitors GC-376, Telaprevir, and Boceprevir.
Jun/09/2021
N-Terminal Finger Stabilizes the S1 Pocket for the Reversible Feline Drug GC376 in the SARS-CoV-2 Mpro Dimer.
Apr/22/2021
Atazanavir Is a Competitive Inhibitor of SARS-CoV-2 Mpro, Impairing Variants Replication In Vitro and In Vivo
Dec/24/2021
Evaluation of RevX solution extract as a potential inhibitor of the main protease of SARS-CoV-2:In vitro study and molecular docking
May/26/2021
Discovery of M Protease Inhibitors Encoded by SARS-CoV-2
Aug/20/2020
Differing pan-coronavirus antiviral potency of boceprevir and GC376 in vitro despite discordant molecular docking predictions
Feb/16/2022
Expedited Approach toward the Rational Design of Noncovalent SARS-CoV-2 Main Protease Inhibitors
May/30/2021
Discovery of Di- and Trihaloacetamides as Covalent SARS-CoV-2 Main Protease Inhibitors with High Target Specificity
Dec/03/2021
Efficacy of GC-376 against SARS-CoV-2 virus infection in the K18 hACE2 transgenic mouse model
May/27/2020
Viral polymerase binding and broad-spectrum antiviral activity of molnupiravir against human seasonal coronaviruses.
Oct/02/2021
Small molecule interactions with the SARS-CoV-2 main protease: In silico all-atom microsecond MD simulations, PELE Monte Carlo simulations, and determination of in vitro activity inhibition
Oct/11/2021
GC-MS, LC-MS/MS, Docking and Molecular Dynamics Approaches to Identify Potential SARS-CoV-2 3-Chymotrypsin-Like Protease Inhibitors from Zingiber officinale Roscoe
Aug/28/2021
Improved SARS-CoV-2 Mpro inhibitors based on feline antiviral drug GC376: Structural enhancements, increased solubility, and micellar studies.
May/30/2021
A fluorescence-based, gain-of-signal, live cell system to evaluate SARS-CoV-2 main protease inhibition
Dec/04/2020
Structure and inhibition of the SARS-CoV-2 main protease reveal strategy for developing dual inhibitors against Mpro and cathepsin L
Dec/09/2020
A multi-targeted approach to identify potential flavonoids against three targets in the SARS-CoV-2 life cycle
Jul/05/2020
Development of optimized drug-like small molecule inhibitors of the SARS-CoV-2 3CL protease for treatment of COVID-19
Apr/01/2021
Bioguided Isolation of Cyclopenin Analogues as Potential SARS-CoV-2 Mpro Inhibitors from Penicillium citrinum TDPEF34
Sep/15/2021
Protease inhibitor GC376 for COVID-19: Lessons learned from feline infectious peritonitis.
Dec/28/2020
Pre-Steady-State Kinetics of the SARS-CoV-2 Main Protease as a Powerful Tool for Antiviral Drug Discovery.
Dec/06/2021
Crystallization of Feline Coronavirus Mpro With GC376 Reveals Mechanism of Inhibition
Feb/24/2022
Cytopathic Effect Assay and Plaque Assay to Evaluate in vitro Activity of Antiviral Compounds Against Human Coronaviruses 229E, OC43, and NL63.
Feb/05/2022
A VSV-based assay quantifies coronavirus Mpro/3CLpro/Nsp5 main protease activity and chemical inhibition
Jan/28/2022

Clinical trials

ID Title Status Phase Start date Completion date
NCT04742738 Safety and Immunogenicity Study of SARS-CoV-2 Nanoparticle Vaccine (GBP510) Adjuvanted With Aluminum Hydroxide (COVID-19) Active, not recruiting Phase 1|Phase 2 Jan/20/2021 Apr/01/2022
  • Alternative id - GBP510_001
  • Interventions - Biological: GBP510 adjuvanted with Alum (RBD 10μg/dose) - Stage 1|Other: Normal saline (0.9% sodium chloride solution) - Stage 1|Biological: GBP510 adjuvanted with Alum (RBD 25μg/dose) - Stage 1|Biological: GBP510 adjuvanted with Alum (RBD 10μg/dose) - Stage 2|Biological: GBP510 adjuvanted with Alum (RBD 25μg/dose)- Stage 2|Other: Normal saline (0.9% sodium chloride solution)- Stage 2
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Korea University Ansan Hospital, Ansan, Korea, Republic of|Dong-A University Hospital, Busan, Korea, Republic of|Kyungpook National University Chilgok Hospital, Daegu, Korea, Republic of|Kyungpook National University Hospital, Daegu, Korea, Republic of|Chonnam National University Hospital, Gwangju, Korea, Republic of|Gachon University Gil Medical Center, Incheon, Korea, Republic of|Inha University Hospital, Incheon, Korea, Republic of|Ewha Womans University Medical Center, Seoul, Korea, Republic of|Hallym University Medical Center, Seoul, Korea, Republic of|Korea University Anam Hospital, Seoul, Korea, Republic of|Korea University Guro Hospital, Seoul, Korea, Republic of|Ajou University Hospital, Suwon, Korea, Republic of
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Prevention
  • Enrollment - 260
  • Age - 19 Years to 85 Years   (Adult, Older Adult)
  • Outcome measures - Occurrence of immediate systemic reactions - Stage 1|Occurrence of solicited local Adverse Events (AEs) during 7 days post each vaccination - Stage 1|Occurrence of solicited systemic AEs during 7 days post each vaccination - Stage 1|Occurrence of unsolicited AEs during 28 days post each vaccination - Stage 1|Occurrence of Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs) and Adverse Events of Special Interest (AESIs) during the whole study period - Stage 1|(Only in Sentinel group) Occurrence of out-of-normal range clinical laboratory test results (including change from baseline values) during 7 days post 1st vaccination - Stage 1|GMT of IgG antibody to the SARS-CoV-2 RBD measured by Enzyme-linked Immunosorbent Assay (ELISA) - Stage 2|GMFR of IgG antibody to the SARS-CoV-2 RBD from baseline measured by ELISA - Stage 2|Percentage of participants with ≥ 4-fold rise from baseline in ELISA IgG titer - Stage 2|GMT of neutralizing antibody to the SARS-CoV-2 measured by pseudovirus and wild-type virus neutralization assays - Stage 2|GMFR of neutralizing antibody to the SARS-CoV-2 from baseline measured by pseudovirus and wild-type virus neutralization assays - Stage 2|Percentage of participants with ≥ 4-fold rise from baseline in pseudovirus and wild-type neutralizing antibody titer - Stage 2|Cell-mediated response for both Th1 and Th2 (e.g. INF-γ, IL-4 using Enzyme-linked ImmunoSpot (ELISpot) or other system) - Stage 2|GMT of IgG antibody to the SARS-CoV-2 RBD measured by ELISA - Stage 1|GMFR of IgG antibody to the SARS-CoV-2 RBD from baseline measured by ELISA - Stage 1|Percentage of participants with ≥ 4-fold rise from baseline in ELISA IgG titer - Stage 1|GMT of neutralizing antibody to the SARS-CoV-2 measured by pseudovirus and wild-type virus neutralization assays - Stage 1|GMFR of neutralizing antibody to the SARS-CoV-2 from baseline measured by pseudovirus and wild-type virus neutralization assays - Stage 1|Percentage of participants with ≥ 4-fold rise from baseline in pseudovirus and wild-type neutralizing antibody titer - Stage 1|Cell-mediated response for both Th1 and Th2 (e.g. INF-γ, IL-4 using ELISpot or other system) - Stage 1|Occurrence of immediate systemic reactions - Stage 2|Occurrence of solicited local AEs during 7 days post each vaccination - Stage 2|Occurrence of solicited systemic AEs during 7 days post each vaccination - Stage 2|Occurrence of unsolicited AEs during 28 days post each vaccination - Stage 2|Occurrence of SAEs, MAAEs and AESIs during the whole study period - Stage 2
NCT05065645 Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled APN01 Developed as Treatment for COVID-19 Not yet recruiting Phase 1 Oct/01/2021 Jan/01/2022
  • Alternative id - APN01-01-INHAL
  • Interventions - Drug: Angiotensin Converting Enzyme 2|Drug: Sodium chloride
  • Study type - Interventional
  • Study results - No Results Available
  • Locations -
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
  • Enrollment - 40
  • Age - 18 Years to 55 Years   (Adult)
  • Outcome measures - Adverse events|Vital signs: Supine blood pressure assessed by systolic and diastolic blood pressure in mmHg|Vital signs: Resting pulse rate measured in beats per minute|Vital signs: Body temperature assessed contactless via TriTemp thermometer in degree C|Vital signs: Respiratory rate measured in breaths/min|Vital signs: Peripheral oxygen saturation (SaO2) measured in %|Clinical laboratory tests: Clinically significant changes of hematology, clinical chemistry and coagulation assessed via blood sample collection|Clinical laboratory tests: Clinically significant changes of urinalysis measurement assessed via urin collection|Physical examination: Abnormal findings of the general appearance|Physical examination: Abnormal findings of the ears|Physical examination: Abnormal findings of the nose|Physical examination: Abnormal findings of the head|Physical examination: Abnormal findings of the eyes|Physical examination: Abnormal findings of the dermatologic system|Physical examination: Abnormal findings of the mouth/throat/neck|Physical examination: Abnormal findings of the thyroid|Physical examination: Abnormal findings of the lymph nodes|Physical examination: Abnormal findings of the respiratory system|Physical examination: Abnormal findings of the cardiovascular system|Physical examination: Abnormal findings of the gastrointestinal system|Physical examination: Abnormal findings of the extremities|Physical examination: Abnormal findings of the musculoskeletal system|Physical examination: Abnormal findings of the neurologic system|Physical examination: Abnormal findings of the psychiatric system|Heart function: QT interval corrected for heart rate (QTc) (Bazett's correction [QTcB]) in msec assessed via Twelve lead ECG|Pulmonary function assessed via Forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) measured in L by spirometry|Pulmonary function assessed via Peak expiratory flow (PEF) measured in L/s by spirometry|Pulmonary function assessed via FEV1/FVC ratio measured in % by spirometry|Pulmonary function assessed via Total lung capacity (TLC) and Residual volume (RV) measured in L by body plethysmography|Fractional Exhaled Nitric Oxide (FeNO) levels measured in parts per billion (ppb) - in MAD cohort only
NCT04847141 A Study to Evaluate the Safety and Efficacy of C19-IG 20% in SARS-CoV-2 Infected Asymptomatic Ambulatory Outpatients Terminated Phase 3 Apr/28/2021 Dec/27/2021
  • Alternative id - GC2010|2021-000269-34
  • Interventions - Biological: C19-IG 20%|Drug: 0.9% Sodium chloride
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - CAP Gornal, L'Hospitalet de Llobregat, Barcelona, Spain|CAP Navàs, Navàs, Barcelona, Spain|CAP Sant Fèlix, Sabadell, Barcelona, Spain|Centro de Salud Nuestra Señora del Pilar, Alcalá de Henares, Madrid, Spain|Centro de Salud Presentación Sabio, Móstoles, Madrid, Spain|CAP Manso, Barcelona, Spain|CAP Maluquer Salvador, Girona, Spain|Centro de Salud San Andrés, Madrid, Spain|Centro de Salud Fuentelarreina, Madrid, Spain|Centro de Salud Hacienda de Pavones Sureste, Madrid, Spain|Centro de Salud Isla de Oza Noroeste, Madrid, Spain|Hospital Sant Pau i Santa Tecla, Tarragona, Spain
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
  • Enrollment - 465
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Percentage of Asymptomatic Participants who Remain Asymptomatic, i.e., who do not Develop Symptomatic COVID-19|Change from Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load (log10 copies/mL)|Percentage of Participants who Remain in an Outpatient Setting and Maintain Peripheral Oxygen Saturation by Pulse Oximetry (SpO2) ≥94% on Room Air|Percentage of Participants Negative for SARS-CoV-2 by Polymerase Chain Reaction (PCR)|Time to Negative SARS-CoV-2 PCR|Percentage of Participants who Require Oxygen (O2) Supplementation|Duration of Any Oxygen|Absolute Value Score on a 7-point Ordinal Scale|Mean Change from Baseline in the 7-point Ordinal Scale|Percentage of Participants in Each Severity Category of the 7-point Ordinal Scale|Change from Baseline in National Early Warning Score (NEWS)|Percentage of Participants who Require At Least One COVID-19 Related Medically Attended Visit for Management/Treatment of COVID-19 which may Occur in Any Setting|Percentage of Participants who Require Hospital Admission for Medical Care (Non-Quarantine Purposes)|Duration of Hospital Stay|Percentage of Participants who Require Intensive Care Unit (ICU) Admission or Initiation of ICU Level Care|Duration of ICU Stay|Percentage of Participants Requiring Invasive Mechanical Ventilation|Duration of Invasive Mechanical Ventilation|Number of Participants with All-Cause Mortality|Number of Participants with Critical COVID-19 Illness|Length of Time to Clinical Progression to Critical COVID-19 Illness|Time to COVID-19 Symptoms
NCT04944121 Phase 2 Study of RSLV-132 in Subjects With Long COVID Recruiting Phase 2 Jun/25/2021 Mar/31/2022
  • Alternative id - 132-05
  • Interventions - Drug: RSLV-132|Drug: Sodium Chloride 0.9%
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Resolve Clinical Center, Mobile, Alabama, United States|Resolve Clinical Center, Coral Gables, Florida, United States|Resolve Clinical Center, Pompano Beach, Florida, United States|Resolve Clinical Center, Knoxville, Tennessee, United States
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
  • Enrollment - 70
  • Age - 18 Years to 75 Years   (Adult, Older Adult)
  • Outcome measures - PROMIS Fatigue SF 7a T-score|FACIT Fatigue questionnaire|Long COVID-19-related Symptom Assessment patient questionnaire|Patient-reported Global Impression of Severity questionnaire|Digit Symbol Substitution Test|Physician Global Assessment
NCT04604327 Comparison of Two Different Doses of Bemiparin in COVID-19 Recruiting Phase 3 Oct/26/2020 Jul/31/2021
  • Alternative id - BEMICOP
  • Interventions - Drug: Bemiparin sodium
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Hospital Rey Juan Carlos, Móstoles, Madrid, Spain|Clinica Universidad de Navarra, Pamplona, Navarra, Spain|Hospital Clinic, Barcelona, Spain|Hospital Sant Pau, Barcelona, Spain|Hospital Universitario Bellvitge, L'Hospitalet De Llobregat, Spain|Fundación Jiménez Díaz, Madrid, Spain|Hospital Clínico San carlos, Madrid, Spain|Hospital Universitario La Paz, Madrid, Spain|Complejo Hospitalario de Navarra, Pamplona, Spain|Hospital Universitario de Salamanca, Salamanca, Spain|Complejo Hospitalario de Toledo, Toledo, Spain|Hospital Universitario Río Hortega, Valladolid, Spain
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
  • Enrollment - 164
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Clinical deterioration
NCT04374591 The Role of Sodium Bicarbonate as Adjuvant Treatment of Computed Tomography Identified COVID-19 Pneumonia Active, not recruiting Not Applicable Aug/01/2020 Nov/01/2020
  • Alternative id - Sodium Bicarbonate COVID-19
  • Interventions - Drug: Sodium Bicarbonate
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Gomhoria Street, Mansoura, Outside U.S./Canada, Egypt
  • Study designs - Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 180
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Time to clinical recovery|Pulmonary recovery status
NCT04871815 Effects of Sodium Pyruvate Nasal Spray in COVID-19 Long Haulers. Completed Phase 2|Phase 3 Apr/27/2021 Mar/07/2022
  • Alternative id - CSI-COVID-19_009
  • Interventions - Drug: sodium pyruvate nasal spray
  • Study type - Interventional
  • Study results - Has Results
  • Locations - Missouri State University, Springfield, Missouri, United States
  • Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 22
  • Age - 18 Years to 40 Years   (Adult)
  • Outcome measures - Change in the Symptoms of Long COVID-19 Patients|Change in Body Temperature in Long COVID-19 Patients|Change in Pulse Rate in Long COVID-19 Patients|Change in Blood Oxygenation in Long COVID-19 Patients
NCT05035524 A Randomized Controlled Trial to Investigate The Role of Adjuvant Inhalable Sodium Bicarbonate Solution 8.4% in Treatment of COVID-19 Active, not recruiting Not Applicable Sep/01/2021 Mar/01/2022
  • Alternative id - SB-COVID
  • Interventions - Drug: Sodium Bicarbonate Solution|Drug: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Mansoura University Hospital - Chest Departement, Mansoura, DK, Egypt
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 340
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - The time interval to recovery defined as the first day
NCT04806061 Urine Alkalinisation in COVID-19 Not yet recruiting Not Applicable Apr/15/2021 Dec/31/2022
  • Alternative id - GSTT COVID-AKI
  • Interventions - Drug: Sodium bicarbonate|Drug: standard care
  • Study type - Interventional
  • Study results - No Results Available
  • Locations -
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
  • Enrollment - 80
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - urinary alkalisation|acute kidney injury
NCT04647604 Resolving Inflammatory Storm in COVID-19 Patients by Omega-3 Polyunsaturated Fatty Acids - Completed Phase 2 Jun/23/2020 Jul/07/2021
  • Alternative id - 2020-002293-28
  • Interventions - Drug: Omegaven®|Drug: Sodium chloride
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Karolinska Universitetssjuhuset, Stockholm, Sweden|Södersjukhuset, Stockholm, Sweden
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment
  • Enrollment - 23
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Changes in inflammatory biomarkers|Changes in proresolving mediators|Changes in fatty acids in the erythrocyte fraction|Changes in cardiac biomarkers|Changes in biomarkers of organ damage|Changes in thrombosis parameters|Changes in coagulation parameters|Changes in markers of infection|Changes in infection load|Changes in clinical parameters|Length of hospital stay|Complications
NCT04824365 Sodium Pyruvate Nasal Spray Treatment of COVID-19 and Influenza Infections Recruiting Phase 2|Phase 3 Apr/12/2021 Jun/01/2022
  • Alternative id - CSI-COVID-19_007
  • Interventions - Drug: Sodium Pyruvate|Other: Saline
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Family First Medical Research Center, Virginia Gardens, Florida, United States|Missouri State University, Springfield, Missouri, United States
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Outcomes Assessor)|Primary Purpose: Treatment
  • Enrollment - 60
  • Age - 18 Years to 40 Years   (Adult)
  • Outcome measures - Evaluate the ability of inhaled nasal sodium pyruvate to change COVID-19 or influenza viral titers.|Evaluate the ability of inhaled nasal sodium pyruvate to change the symptoms of COVID-19 or influenza.
NCT04530448 Coronavirus Induced Acute Kidney Injury: Prevention Using Urine Alkalinization Active, not recruiting Phase 4 Oct/05/2020 Mar/01/2022
  • Alternative id - WVU Protocol #2005006707
  • Interventions - Drug: Sodium bicarbonate|Other: Standard of Care
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - WVU Medicine Heart & Vascular Institute, Morgantown, West Virginia, United States
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 3
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - pH|Number of Days Alive Free of Stage 2-3 AKI|Stage 2-3 AKI|Vent-Free|Hospital-Free
NCT04377503 Tocilizumab Versus Methylprednisolone in the Cytokine Release Syndrome of Patients With COVID-19 Not yet recruiting Phase 2 May/01/2020 Nov/01/2020
  • Alternative id - covid-19 hsd
  • Interventions - Drug: Tocilizumab 180 MG/ML|Drug: Methylprednisolone Sodium Succinate
  • Study type - Interventional
  • Study results - No Results Available
  • Locations -
  • Study designs - Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 40
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Patient clinical status 15 days after randomization|Improving oxygenation|Thorax CT improvement|ICU length of stay|Duration of mechanical ventilation|Incidence of acute kidney (AKI) with necessity of renal replacement therapy
NCT05289037 COVID-19 Variant Immunologic Landscape Trial (COVAIL Trial) Not yet recruiting Phase 1|Phase 2 Mar/28/2022 Mar/28/2026
  • Alternative id - 22-0004|5UM1AI148684-03
  • Interventions - Biological: mRNA-1273|Biological: mRNA-1273.351|Other: Sodium Chloride, 0.9%
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - University of Alabama at Birmingham School of Medicine - Alabama Vaccine Research Clinic, Birmingham, Alabama, United States|University of California, San Diego - Antiviral Research Center, San Diego, California, United States|Zuckerberg San Francisco General Hospital, UCSF Positive Health Program, San Francisco, California, United States|The George Washington University Medical Faculty Associates - Infectious Diseases, Washington, District of Columbia, United States|Howard University - Department of Medicine - Division of Infectious Disease, Washington, District of Columbia, United States|Morehouse School of Medicine - Clinical Research Center, Atlanta, Georgia, United States|Emory Children's Center - Pediatric Infectious Diseases, Atlanta, Georgia, United States|Emory Vaccine Center - The Hope Clinic, Decatur, Georgia, United States|University of Illinois at Chicago College of Medicine - Division of Infectious Diseases, Chicago, Illinois, United States|University of Iowa Hospitals & Clinics - Department of Internal Medicine, Iowa City, Iowa, United States|Tulane University Clinical Translational Unit, New Orleans, Louisiana, United States|Brigham and Women's Hospital - Infectious Diseases, Boston, Massachusetts, United States|Saint Louis University - Center for Vaccine Development, Saint Louis, Missouri, United States|Washington University School of Medicine in St. Louis - Infectious Disease Clinical Research Unit, Saint Louis, Missouri, United States|NYU Grossman School, NYU Langone Vaccine Center, Long Island site, Mineola, New York, United States|NYU Langone Vaccine Center Research Clinic, Manhattan site, New York, New York, United States|Columbia University Irving Medical Center - Division of Infectious Diseases - Harkness Pavilion, New York, New York, United States|University of Rochester Medical Center - Vaccine Research Unit, Rochester, New York, United States|The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States|Duke Human Vaccine Institute - Duke Vaccine and Trials Unit, Durham, North Carolina, United States|Baylor College of Medicine - Molecular Virology and Microbiology, Houston, Texas, United States|University of Texas Medical Branch - Division of Infectious Disease, League City, Texas, United States|Kaiser Permanente Washington Health Research Institute - Vaccines and Infectious Diseases, Seattle, Washington, United States|The University of Washington - Virology Research Clinic, Seattle, Washington, United States
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
  • Enrollment - 1500
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Change from baseline in Geometric Mean Titers (GMT)|Change from baseline in Geometric Mean Fold Rise (GMFR)|Change from baseline in Geometric Mean Ratio|Adverse Events (AEs) leading to withdrawal from the study|Incidence of Adverse Events of Special Interest (AESI)|Incidence of Medically Attended Adverse Events (MAAEs)|Incidence of New Onset Chronic Medical Conditions (NOCMCs)|Incidence of Serious Adverse Events (SAE)|Incidence of Solicited Adverse Events|Incidence of Unsolicited Adverse Events
NCT04343729 Methylprednisolone in the Treatment of Patients With Signs of Severe Acute Respiratory Syndrome in Covid-19 Completed Phase 2 Apr/18/2020 Oct/20/2020
  • Alternative id - CAEE: 30615920.2.0000.0005
  • Interventions - Drug: Methylprednisolone Sodium Succinate|Drug: Placebo solution
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Hospital e Pronto Socorro Delphina Rinaldi Abdel Aziz, Manaus, Amazonas, Brazil
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
  • Enrollment - 416
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Mortality rate at day 28|Mortality rate on days 7, 14 and 28|Incidence of orotracheal intubation|Change in oxygenation index
NCT04397510 Nebulized Heparin for the Treatment of COVID-19 Induced Lung Injury Enrolling by invitation Phase 4 Jun/01/2020 Dec/31/2021
  • Alternative id - FHHep518
  • Interventions - Drug: Heparin|Drug: 0.9% Sodium-chloride
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Frederick Health Hospital, Frederick, Maryland, United States
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
  • Enrollment - 50
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Mean daily PaO2 to FiO2 ratio|Duration of mechanical ventilation|ICU length of stay|Mortality Rate|Incidence of adverse drug events
NCT04530578 Nebulized Heparin in Severe Acute Respiratory Syndrome COVID-19 Recruiting Phase 4 Jun/01/2020 Jun/01/2021
  • Alternative id - CSanCamilo
  • Interventions - Drug: Heparin sodium|Drug: Enoxaparin
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Clinica San Camilo, Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 200
  • Age - 18 Years to 100 Years   (Adult, Older Adult)
  • Outcome measures - Percentage of patients requirement mechanical ventilation|Percentage of patients with PaO2 to Fi02 ratio > 300|Lengths of hospital-stay|Mortality rate
NCT04755972 Mucolytics in Patients on Invasive Mechanical Ventilation Due to Severe Acute Respiratory Syndrome Coronavirus 2 Completed Not Applicable Oct/01/2020 Jul/29/2021
  • Alternative id - 2181-147-01/06/M.S.-20-02
  • Interventions - Other: Inhalation of N-acetylcysteine|Other: Inhalation of 5% sodium chloride|Other: Inhalation of 8,4% sodium bicarbonate
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Clinical Hospital Centre Split, Split, Croatia
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
  • Enrollment - 175
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Difference between 4 arms regarding ventilator-associated pneumonia rate|Number of ventilator-free days|Mortality
NCT05094596 Effect of Montelukast Therapy on Clinical Course, Pulmonary Function, and Mortality in Patients With COVID-19 Not yet recruiting Phase 4 Oct/22/2021 Jan/22/2022
  • Alternative id - ATATURK-BUGRA-001
  • Interventions - Drug: Standart treatment group|Drug: Montelukast sodium 10 mg treatment|Drug: Montelukast sodium 20 mg treatment
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Ataturk University, Erzurum, Turkey
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 180
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Pulmonary function test
NCT04750343 Safety and Immunogenicity Study of SARS-CoV-2 Nanoparticle Vaccine (GBP510) Adjuvanted With or Without AS03 (COVID-19) Active, not recruiting Phase 1|Phase 2 Feb/03/2021 Jun/01/2022
  • Alternative id - GBP510_002
  • Interventions - Biological: GBP510 adjuvanted with AS03 (RBD 10μg/dose) - Stage 1|Biological: GBP510 (RBD 10μg/dose) - Stage 1|Other: Normal saline (0.9% sodium chloride solution) - Stage 1|Biological: GBP510 adjuvanted with AS03 (RBD 25μg/dose) - Stage 1|Biological: GBP510 (RBD 25μg/dose) - Stage 1|Biological: GBP510 adjuvanted with AS03 (RBD 10μg/dose) - Stage 2|Biological: GBP510 adjuvanted with AS03 (RBD 25μg/dose)- Stage 2|Biological: GBP510 (RBD 25μg/dose)- Stage 2|Other: Normal saline (0.9% sodium chloride solution)- Stage 2
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Korea University Ansan Hospital, Ansan, Korea, Republic of|Dong-A University Hospital, Busan, Korea, Republic of|Kyungpook National University Chilgok Hospital, Daegu, Korea, Republic of|Kyungpook National University Hospital, Daegu, Korea, Republic of|Chonnam National University Hospital, Gwangju, Korea, Republic of|Gachon University Gil Medical Center, Incheon, Korea, Republic of|Inha University Hospital, Incheon, Korea, Republic of|Korea University Anam Hospital, Seongnam-si, Korea, Republic of|Ewha Womans University Medical Center, Seoul, Korea, Republic of|Hallym University Medical Center, Seoul, Korea, Republic of|Korea University Guro Hospital, Seoul, Korea, Republic of|Severance Hospital, Seoul, Korea, Republic of|Ajou University Hospital, Suwon, Korea, Republic of|Wonju Severance Christian Hospital, Wonju, Korea, Republic of
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Prevention
  • Enrollment - 328
  • Age - 19 Years to 85 Years   (Adult, Older Adult)
  • Outcome measures - Occurrence of immediate systemic reactions - Stage 1|Occurrence of solicited local Adverse Events (AEs) during 7 days post each vaccination - Stage 1|Occurrence of solicited systemic AEs during 7 days post each vaccination - Stage 1|Occurrence of unsolicited AEs during 28 days post each vaccination - Stage 1|Occurrence of Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs) and Adverse Events of Special Interest (AESIs) during the whole study period - Stage 1|(Only in Sentinel group) Occurrence of out-of-normal range clinical laboratory test results (including change from baseline values) during 7 days post 1st vaccination - Stage 1|GMT of IgG antibody to the SARS-CoV-2 RBD measured by Enzyme-linked Immunosorbent Assay (ELISA) - Stage 2|GMFR of IgG antibody to the SARS-CoV-2 RBD from baseline measured by ELISA - Stage 2|Percentage of participants with ≥ 4-fold rise from baseline in ELISA IgG titer - Stage 2|GMT of neutralizing antibody to the SARS-CoV-2 measured by pseudovirus and wild-type virus neutralization assays - Stage 2|GMFR of neutralizing antibody to the SARS-CoV-2 from baseline measured by pseudovirus and wild-type virus neutralization assays - Stage 2|Percentage of participants with ≥ 4-fold rise from baseline in pseudovirus and wild-type neutralizing antibody titer - Stage 2|Cell-mediated response for both Th1 and Th2 (e.g. INF-γ, IL-4 using Enzyme-linked ImmunoSpot (ELISpot) or other system) - Stage 2|GMT of IgG antibody to the SARS-CoV-2 RBD measured by ELISA - Stage 1|GMFR of IgG antibody to the SARS-CoV-2 RBD from baseline measured by ELISA - Stage 1|Percentage of participants with ≥ 4-fold rise from baseline in ELISA IgG titer - Stage 1|GMT of neutralizing antibody to the SARS-CoV-2 measured by pseudovirus and wild-type virus neutralization assays - Stage 1|GMFR of neutralizing antibody to the SARS-CoV-2 from baseline measured by pseudovirus and wild-type virus neutralization assays - Stage 1|Percentage of participants with ≥ 4-fold rise from baseline in pseudovirus and wild-type neutralizing antibody titer - Stage 1|Cell-mediated response for both Th1 and Th2 (e.g. INF-γ, IL-4 using ELISpot or other system) - Stage 1|Occurrence of immediate systemic reactions - Stage 2|Occurrence of solicited local AEs during 7 days post each vaccination - Stage 2|Occurrence of solicited systemic AEs during 7 days post each vaccination - Stage 2|Occurrence of unsolicited AEs during 28 days post each vaccination - Stage 2|Occurrence of SAEs, MAAEs and AESIs during the whole study period - Stage 2
NCT04776317 Chimpanzee Adenovirus and Self-Amplifying mRNA Prime-Boost Prophylactic Vaccines Against SARS-CoV-2 in Healthy Adults Recruiting Phase 1 Mar/25/2021 Sep/19/2022
  • Alternative id - 20-0034|5UM1AI148684-03
  • Interventions - Biological: ChAdV68-S|Biological: ChAdV68-S-TCE|Biological: SAM-LNP-S|Biological: SAM-LNP-S-TCE|Other: Sodium Chloride, 0.9%
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Emory Vaccine Center - The Hope Clinic, Decatur, Georgia, United States|Saint Louis University - Center for Vaccine Development, Saint Louis, Missouri, United States|Baylor College of Medicine - Molecular Virology and Microbiology, Houston, Texas, United States|The University of Washington - Virology Research Clinic, Seattle, Washington, United States
  • Study designs - Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
  • Enrollment - 147
  • Age - 18 Years to 99 Years   (Adult, Older Adult)
  • Outcome measures - Occurrence of Adverse Events of Special Interest (AESIs)|Occurrence of clinical safety laboratory adverse events by severity grade|Occurrence of Serious Adverse Events (SAEs)|Occurrence of solicited local reactogenicity adverse events (AEs)|Occurrence of solicited systemic reactogenicity adverse events (AEs)|Occurrence of unsolicited adverse events (AEs)|Geometric mean fold rise from baseline in titer measured by a SARS-CoV-2 neutralization assay|Geometric mean fold rise from baseline in titer of receptor-binding domain (RBD) specific Immunoglobulin G (IgG)|Geometric mean fold rise from baseline in titer of Spike-specific Immunoglobulin G (IgG)|Geometric mean titer measured by a SARS-CoV-2 neutralization assay|Geometric mean titer of receptor-binding domain (RBD) specific Immunoglobulin G (IgG)|Geometric mean titer of Spike-specific Immunoglobulin G (IgG)|Percent of cells expressing a cytokine by cell type (CD4+ or CD8+), cytokine set (Th1 or Th2 cytokine for CD4+ and CD8+ cytokine for CD8+ or other combinations of interest) and peptide pool (covering spike and T cell epitope regions)|Percentage of subjects who seroconverted for RBD from wild-type virus and emergent viral strains|Percentage of subjects who seroconverted for spike protein from wild-type virus and emergent viral strains|Percentage of subjects who seroconverted for wild-type virus and emergent viral strains|Rate of spot-forming cell per million cells by peptide pool|Responder status, derived from the intracellular cytokine staining (ICS) cell counts for each set of applicable cytokines and each peptide pool|Responder status, determined by interferon (IFN) gamma Enzyme Linked Immunospot Assay (ELISpot) for each peptide pool|Th1/Th2 cytokine balance of T cell response
NCT04348305 Hydrocortisone for COVID-19 and Severe Hypoxia Completed Phase 3 Apr/17/2020 Sep/08/2021
  • Alternative id - RH-ITA-008|2020-001395-15
  • Interventions - Drug: Hydrocortisone|Drug: Sodium Chloride 9mg/mL
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Aarhus University Hospital - Dept of Intensive care, Aarhus, Denmark|Rigshospitalet, Copenhagen, Denmark|Dept of Infectious diseases, Rigshospitalet, Copenhagen, Denmark|Herlev Hospital - Dept. of Intensive Care, Herlev, Denmark|North Zealand Hospital, Hillerød, Denmark|Hvidovre Hospital - Dept of Infectious diseases, Hvidovre, Denmark|Hvidovre Hospital - Dept of Intensive Care, Hvidovre, Denmark|Hvidovre Hospital - Dept of Pulmonary Medicine, Hvidovre, Denmark|Kolding Hospital, Kolding, Denmark|Køge Hospital, Køge, Denmark|Dept of Intensive Care, Odense University Hospital, Odense, Denmark|Roskilde Hospital, Roskilde, Denmark|Slagelse Hospital, Slagelse, Denmark|Viborg Hospital, Viborg, Denmark
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
  • Enrollment - 30
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Days alive without life support at day 28|All-cause mortality at day 28|Days alive without life support at day 90|All-cause mortality at day 90|Number of participants with one or more serious adverse reactions|Days alive and out of hospital at day 90|All-cause mortality at 1 year after randomisation|Health-related quality of life at 1 year
NCT04406389 Anticoagulation in Critically Ill Patients With COVID-19 (The IMPACT Trial) Recruiting Phase 4 Oct/13/2020 Dec/01/2022
  • Alternative id - 20-04021936
  • Interventions - Drug: Enoxaparin sodium|Drug: Unfractionated heparin|Drug: Fondapariniux|Drug: Argatroban
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Weill Cornell Medicine, New York, New York, United States
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 186
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - 30-day mortality|Length of Intensive Care Unit (ICU) Stay in Days|Number of documented venous thromboembolism (VTE), arterial thrombosis (stroke, myocardial infarction, other) and microthrombosis events|Number of major and clinically relevant non-major bleeding events
NCT04826588 Randomised Evaluation of COVID-19 Therapy (RECOVERY) in Children With PIMS-TS in Switzerland (SWISSPED-RECOVERY) Recruiting Phase 3 May/23/2021 Jul/01/2022
  • Alternative id - 2021-00362; ks21Bielicki2
  • Interventions - Drug: Methylprednisolone sodium succinate 10 mg/kg intravenously|Biological: Human normal immunoglobulin (IVIg)|Drug: Methylprednisolone sodium succinate 2 mg/kg
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Cantonal Hospital Aarau, Department of Paediatrics, Aarau, Switzerland|University of Basel Children's Hospital, Basel, Switzerland|Ente Ospedaliero Cantonale Ticino (EOC) Pediatrica, Bellinzona, Switzerland|Department of Pediatrics, University of Bern, Bern, Switzerland|Department of Child, Woman and, Adolescent Medecine, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland|Department of Pediatrics,University Hospital of Lausanne (CHUV), Lausanne, Switzerland|Department of Pediatrics, Cantonal Hospital Luzern, Luzern 16, Switzerland|Children's Hospital of Eastern Switzerland, St. Gallen, Switzerland|Department of Pediatrics, Cantonal Hospital Fribourg, Villars-sur-Glâne, Switzerland|University Children's Hospital Zuerich, Zuerich, Switzerland
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 75
  • Age - 44 Weeks to 18 Years   (Child, Adult)
  • Outcome measures - Hospital length of stay|All-cause mortality among patients|Composite endpoint of death or need for mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
NCT05166876 Brequinar Combined With Dipyridamole in Patients With Mild to Moderate COVID-19 Recruiting Phase 2 Feb/01/2022 Jul/01/2022
  • Alternative id - CCB-CRISIS-04
  • Interventions - Drug: Brequinar Sodium|Drug: Dipyridamole 75 MG|Drug: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - RIMS - Government Medical College, Srikakulam, Andhra Pradesh, India|King George Hospital, Visakhapatnam, Andhra Pradesh, India|JIPMER Hospital, Pondicherry, Puducherry, India|Noble Hospital, Hadapsar, Pune, India|Panimalar Hospital, Chennai, Tamil Nadu, India
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
  • Enrollment - 112
  • Age - 18 Years to 65 Years   (Adult, Older Adult)
  • Outcome measures - Safety and tolerability of the brequinar-dipyridamole combination in COVID-19 subjects|Reduction of SARS-CoV-2 levels using qPCR through Day 29 and at days 4, 8, 12, 15, 22, and 29|Reduction in time to symptom improvement|Reduction in percentage of subjects requiring hospital admission/re-admission as an in-patient for >24 hours|Reduction in percentage of subjects requiring medical attended visits, e.g., hospitalization, emergency room visits, Urgent Care/Family Doctor visits|Reduction in percentage of subjects requiring supplemental support such as oxygen
NCT04389840 Dociparstat for the Treatment of Severe COVID-19 in Adults at High Risk of Respiratory Failure Terminated Phase 2|Phase 3 Jun/03/2020 May/20/2021
  • Alternative id - CMX-DS-004
  • Interventions - Drug: Dociparstat sodium|Drug: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - University of Alabama at Birmingham, Birmingham, Alabama, United States|Advanced Pulmonary Research Institute/Wellington Regional Medical Center, Loxahatchee Groves, Florida, United States|Augusta University, Augusta, Georgia, United States|Our Lady of the Lake, Baton Rouge, Louisiana, United States|Tulane University, New Orleans, Louisiana, United States|University Medical Center, New Orleans, Louisiana, United States|William Beaumont Hospital, Royal Oak, Michigan, United States|Wake Forest Baptist Health, Winston-Salem, North Carolina, United States|Texas Health Harris Methodist Hospital Fort Worth, Dallas, Texas, United States|Ascension St. Francis Hospital, Milwaukee, Wisconsin, United States|Ascension All Saints Hospital, Racine, Wisconsin, United States
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
  • Enrollment - 3
  • Age - 18 Years to 85 Years   (Adult, Older Adult)
  • Outcome measures - Proportion of participants who are alive and free of invasive mechanical ventilation|All-cause mortality
NCT04655716 Urine Alkalinisation to Prevent AKI in COVID-19 Active, not recruiting Phase 3 Jul/19/2021 Dec/31/2022
  • Alternative id - 283852
  • Interventions - Drug: Sodium Bicarbonate 150Meq/L/D5W Inj
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Guy's & St Thomas' NHS Foundation Trust, London, United Kingdom
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 80
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - proportion of patients treated who achieve >50% of urine measurements above pH 7.0 over the duration of intervention|number of days alive and free of stage 2-3 AKI (up to day 28) in each group|proportion of patients developing stage 2-3 AKI|ventilator-free days|hospital-free days
NCT04721457 The Efficacy of Pre-procedural Mouth Rinses on COVID-19 Saliva Viral Load Completed Phase 4 Jan/03/2021 Dec/10/2021
  • Alternative id - 1384
  • Interventions - Drug: Distilled Water|Drug: 1% Povidone Iodine (PVP-I)|Drug: 1.5% Hydrogen Peroxide (H2O2)|Drug: 0.075% Cetylpyridinium Chloride (CPC)|Drug: 0.1% Sodium Hypochlorite
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Alhamra TETAMMAN clinic (PHC), Jeddah, Saudi Arabia
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Prevention
  • Enrollment - 120
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Change in SARS-Cov-2 viral load (Quantitative Real-Time Reverse-Transcriptase Polymerase Chain Reaction (qRT-PCR))|ct values
NCT04743011 Enriched Heparin Anti COVID-19 Trial Recruiting Phase 1|Phase 2 Jun/01/2021 Dec/31/2021
  • Alternative id - UPECLIN-MB-2
  • Interventions - Drug: Heparin sodium|Drug: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Hospital das Clinicas de Boucatu, Botucatu, Sao Paulo, Brazil|School of Medicine at Botucatu- Paulista State University- UNESP, São Paulo, Brazil, Botucatu, SP, Brazil
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
  • Enrollment - 50
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Change in activated partial thromboplastin time (APTT) > 1.5|Viral load in nasal swab reverse transcription polymerase chain reaction (RT-PCR).|Number of participants needing supplemental oxygen therapy|Number of participants needing mechanical pulmonary ventilation|Number of hospitalization days|Number of participants that develop renal failure|Number of participants that develop major cardiovascular events|Number of participants transferred to the intensive care unit (ICU)|Number of participants presenting secondary pulmonary bacterial infections|Number of participants that develop deep vein thrombosis (DVT)|Number of participants that develop pancreatitis|Number of participants that need corticosteroid therapy|Number of deaths among participants|Number of participants with increased white blood cell count|Number of participants with increased C reactive protein test|Number of participants with deterioration of arterial blood gas paO2/pFiO2 ratio|Number of participants with altered sodium|Number of participants with altered potassium|Number of participants with increased pulmonary area compromised (%)
NCT04419610 RAS and Coagulopathy in COVID19 Completed Early Phase 1 Oct/09/2020 May/12/2021
  • Alternative id - 283093
  • Interventions - Biological: TRV027|Other: sodium chloride 0.9%
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Imperial College NHS Trust, London, United Kingdom
  • Study designs - Allocation: Randomized|Intervention Model: Single Group Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Health Services Research
  • Enrollment - 30
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Coagulopathy associated with COVID-19|Markers of dysregulation of coagulation system|Markers of dysregulation of RAS|Markers of Haemolysis/inflammation|Markers of Haemolysis/Inflammation|Markers of Inflammation (bacterial sepsis)|Markers of organ dysregulation - kidney|Markers of dysregulation of cardiovascular system|marker of dysregulation of endocrine system
NCT04900129 Inhalation of Vapor With Medication (Diclofenac Sodium, Menthol, Methyl Salicylate and N-Acetyl Cysteine) Reduces Oxygen Need and Hospital Stay in COVID-19 Patients - A Case Control Study Completed Phase 1 Dec/01/2020 Dec/30/2020
  • Alternative id - SBMC Barisal 2020 1896
  • Interventions - Combination Product: Menthol 0.02%, Methyl salicylate 0.05%, N- Acetyl cysteine 1.2 gm%, and Diclofenac sodium 1gm%
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - HN Sarker, Barisal, Bangladesh
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
  • Enrollment - 43
  • Age - 20 Years and older   (Adult, Older Adult)
  • Outcome measures - Inhalation of Vapor with Medication (Diclofenac Sodium, Menthol, Methyl Salicylate and N-Acetyl Cysteine) Reduces Oxygen Need and Hospital Stay in COVID-19 Patients - A Case Control Study
NCT04364763 A Study to Evaluate the Effect of RBT-9 on Progression of COVID-19 in High-Risk Individuals (The PREVENT Study) Terminated Phase 2 Aug/05/2020 Sep/30/2021
  • Alternative id - REN-005
  • Interventions - Drug: RBT-9 (90 mg)|Drug: 0.9% sodium chloride (normal saline)
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - New Smyrna Beach, FL, New Smyrna Beach, Florida, United States|Berkley, MI, Berkley, Michigan, United States|El Paso, TX, El Paso, Texas, United States|Fort Worth, TX, Fort Worth, Texas, United States|Houston, Houston, Texas, United States
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 42
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Evaluate the effect of RBT-9 versus placebo on clinical status of COVID-19 patients as measured using the 8-point World Health Organization (WHO) Ordinal Clinical Scale|Time to first occurrence of death from any cause or new/worsened organ dysfunction|All-cause survival|Oxygen saturation (SpO2)/fraction of inspired oxygen (FiO2) ratio|Fever incidence|Acute kidney injury (AKI) incidence|New or worsening congestive heart failure (HF)|Hospitalization status|Ventricular tachycardia or fibrillation lasting at least 30 seconds and/or associated with hemodynamic instability or pulseless electrical activity, or resuscitated cardiac arrest|Oxygen-free days|Intensive care unit (ICU) status|Days on ventilator|Time to and duration of vasopressor or inotrope utilization|Dialysis status
NCT05077917 Cromolyn Sodium for Treatment of COVID-19 Pneumonia Recruiting Phase 3 Nov/15/2021 Dec/01/2022
  • Alternative id - E21197
  • Interventions - Drug: Cromolyn Sodium|Other: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - University Medical Center of El Paso, El Paso, Texas, United States
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
  • Enrollment - 60
  • Age - 18 Years to 80 Years   (Adult, Older Adult)
  • Outcome measures - Change in requirement for oxygen supplementation based on daily assessment of flow (LPM or %Fi O2) and delivery device (cannula, mask, CPAP/BiPAP, ventilator)|Change in respiratory symptoms (cough, shortness of breath, and fatigue) determined by data extraction from medical record, self-assessment by subject, or subject survey as appropriate for stage of the study.|hospital length of stay|change the patient score from the PROMIS survey provided to subjects at days 7, 14, and 21.
NCT04401527 Treatment of Lung Injury From COVID-19 Infection With Intravenous Sodium Nitrite Withdrawn Phase 2 Jul/22/2020 Aug/15/2020
  • Alternative id - SN02-01
  • Interventions - Drug: Sodium Nitrite|Drug: Normal Saline
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Participating Research Facility, Tampa, Florida, United States|Participating Research Facility, Fort Worth, Texas, United States
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
  • Enrollment - 0
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Survival with Unassisted Breathing|Survival without Mechanical Ventilation|Survival without Intensive Care|Survival without Hospitalization|Survival without ECMO|Survival
NCT04490239 Intranasal Heparin Tolerability Study Completed Early Phase 1 Oct/09/2020 Nov/18/2020
  • Alternative id - Intranasal Heparin
  • Interventions - Drug: Intranasal heparin sodium (porcine)
  • Study type - Interventional
  • Study results - Has Results
  • Locations - The University of Mississippi National Center for Natural Products Research, University, Mississippi, United States
  • Study designs - Allocation: N/A|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
  • Enrollment - 6
  • Age - 18 Years to 65 Years   (Adult, Older Adult)
  • Outcome measures - Number of Participants With Normal or Abnormal Activated Partial Thromboplastin Time (aPTT), Acute Phase Day 1|Number of Participants With Normal or Abnormal Activated Partial Thromboplastin Time (aPTT), Acute Phase Day 2|Number of Participants With Normal or Abnormal Activated Partial Thromboplastin Time (aPTT), Chronic Phase Day 14|Number of Participants With Normal or Abnormal Activated Partial Thromboplastin Time (aPTT), Chronic Phase Day 15|Percent Change in Platelet Count From Pre-dose Baseline|Number of Incidents of Epistaxis, Acute Phase|Number of Incidents of Epistaxis, Chronic Phase|Number of Participants With Normal or Abnormal Platelet Counts, Chronic Phase Day 14|Other Adverse Effects, Acute Phase|Other Adverse Effects, Chronic Phase
NCT04537962 Salivary SARS-CoV-2 Load of Covid-19 Patients After Oral Antimicrobial Solutions and Dentifrices Completed Not Applicable Jul/14/2020 Sep/30/2021
  • Alternative id - 4172-20
  • Interventions - Other: Colgate Periogard® mouthwash|Other: Colgate Peroxyl® mouthwash|Other: Colgate Total® Mouthwash|Other: Toothpaste with sodium monofluorophosphate|Other: Toothpaste with sodium fluoride and zinc|Other: Toothpaste with tin fluoride
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Hospital israelita Albert Einstein, Sao Paulo, Brazil
  • Study designs - Allocation: Randomized|Intervention Model: Factorial Assignment|Masking: Triple (Participant, Care Provider, Outcomes Assessor)|Primary Purpose: Supportive Care
  • Enrollment - 202
  • Age - 18 Years to 90 Years   (Adult, Older Adult)
  • Outcome measures - Reduction of SARS-CoV-2 load in the oral mucosa and saliva
NCT04784767 SARS-COV-2-Spike-Ferritin-Nanoparticle (SpFN) Vaccine With ALFQ Adjuvant for Prevention of COVID-19 in Healthy Adults Active, not recruiting Phase 1 Apr/05/2021 Oct/30/2023
  • Alternative id - S-20-03|WRAIR # 2847|EID030|IND 27301
  • Interventions - Biological: 25 µg SpFN_1B-06-PL + ALFQ (QS21 Adjuvant)|Drug: Sodium chloride, USP, for injection (0.9% NaCl)|Biological: 50 µg SpFN_1B-06-PL + ALFQ (QS21 Adjuvant)
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - WRAIR Clinical Trials Center, Silver Spring, Maryland, United States
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Prevention
  • Enrollment - 29
  • Age - 18 Years to 55 Years   (Adult)
  • Outcome measures - Number of participants with local and systemic reactions|Incidents of treatment-adverse events as assessed by FDA Toxicity grading scale.|Number of participants with humoral immune response at Study Day 43 (+/- 2).|Number of participants with binding antibody response rate|Number of participants with neutralizing antibody response rate|Number of participants with ACE-2 binding inhibition
NCT05277285 STS Administration on Coronavirus Disease (COVID-19) Patients in Critical Care Recruiting Phase 2 Mar/16/2022 Feb/28/2023
  • Alternative id - H4COVID
  • Interventions - Drug: Sodium Thiosulfate 25% Solution for Injection
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - General Hospitan of Athens KAT 2nd Department of ICU, Athens, Kifisia, Greece
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 30
  • Age - 18 Years to 110 Years   (Adult, Older Adult)
  • Outcome measures - Comparison of treatment-emergent serious and non-serious adverse events between treatment groups.|World Health Organization clinical progression scale (WHO-CPS) on day 7 from inclusion in the study|WHO-CPS on day 14 from inclusion in the study|WHO-CPS on day 28 from inclusion in the study|Average value of the total sequential organ failure assessment (SOFA) score on day 7|Hydrogen sulfide concentrations daily until day 7 in patient's blood serum.|IL-6 cytokine concentrations daily until day 7 in patient's blood serum.|TNF cytokine concentrations daily until day 7 in patient's blood serum.|Production of Th1, Th2 and T17 cytokines from mononuclear cells of patient's blood on days 1,4 and 7|Ferritin concentrations on days 1,4 and 7|C-reactive protein concentrations on days 1,4 and 7|D-dimers concentrations on days 1,4 and 7|Cytokine IL-6 concentrations on days 1,4 and 7
NCT04573322 Safety and Efficacy of Trans Sodium Crocetinate (TSC) in SARS-CoV-2 (COVID-19) Infected Subjects Completed Phase 1|Phase 2 Sep/10/2020 Apr/29/2021
  • Alternative id - 100-303
  • Interventions - Drug: Trans Sodium Crocetinate|Drug: Normal saline
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - National Institute of Infectious Diseases- Prof. Dr. Matei Balş, Bucharest, Romania
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
  • Enrollment - 25
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)|Time to recovery through Day 28|WHO Ordinal Severity Scale|WHO Ordinal Severity Scale - Time to Improvement|WHO Ordinal Severity Scale - Change from Baseline|National Early Warning Score (NEWS)|National Early Warning Score (NEWS) - Change from Baseline|Mechanical Ventilation|Mechanical Ventilation - Duration|Hospitalization|Oxygenation|Oxygenation - New Oxygen Use|Oxygenation - Advanced Therapies|Oxygenation - Time to Return to Baseline|Oxygenation - Pulse Oximetry|Oxygenation - ABG Measurements|Mortality
NCT05181709 A Live Recombinant Newcastle Disease Virus-vectored COVID-19 Vaccine Phase 1 Study. Recruiting Phase 1 Jan/01/2022 Jul/01/2023
  • Alternative id - STUDY-21-01589
  • Interventions - Drug: Sodium Chloride|Biological: NDV-HXP-S IN low dose|Biological: NDV-HXP-S IM low dose|Biological: NDV-HXP-S IN high dose|Biological: NDV-HXP-S IM high dose
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Icahn School of Medicine at Mount Sinai, New York, New York, United States
  • Study designs - Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
  • Enrollment - 35
  • Age - 19 Years to 59 Years   (Adult)
  • Outcome measures - Number of local and systemic reactions|Number of adverse events (AEs)|Number of serious adverse events (SAEs)|Number of medically-attended adverse events (MAAEs)
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