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NCT04853069
|
Oestrogen Treatment for COVID-19 Symptoms |
Not yet recruiting |
Phase 2 |
May/17/2021 |
Mar/31/2022 |
- Alternative id - MRC-05-099
- Interventions - Drug: Transdermal estradiol gel
- Study type - Interventional
- Study results - No Results Available
- Locations - Hamad Medical Corporation, Doha, Qatar
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 2000
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Evidence of disease progression for mild cases|Evidence of disease progression in hospitalised patients (moderate and severe cases)|Hospital mortality|Duration of hospital admission|Admission to ICU/ HDU facility|Need for renal replacement therapy|Ventilation|Time to being fit for hospital discharge
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NCT04710303
|
COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral Platform in Healthy South African Adults |
Recruiting |
Phase 1 |
Mar/02/2021 |
Apr/01/2022 |
- Alternative id - AW_001_ProVIVA-SA-1
- Interventions - Biological: hAd5-S-Fusion+N-ETSD vaccine
- Study type - Interventional
- Study results - No Results Available
- Locations - Khayelitsha Clinical Research Site, Khayelitsha, South Africa
- Study designs - Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 35
- Age - 18 Years to 50 Years (Adult)
- Outcome measures - Incidence of MAAEs and SAEs|Incidence and severity of solicited local reactogenicity AEs|Incidence and severity of solicited systemic reactogenicity AEs|Incidence and severity of unsolicited AEs|Incidence of changes of laboratory safety examinations|Vital Sign - Temperature|Vital Sign - Heart rate|Vital Sign - Blood Pressure|Vital Sign - Respiratory Rate|GMFR in IgG titer|GMT of S-specific, RBD-specific, and N-specific antibodies|Percentage of participants who seroconverted|GMFR in neutralizing antibody|GMT of neutralizing antibody|Seroconversion rate of neutralizing antibody|New HIV infections in vaccine recipients
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NCT05205707
|
Association of Circulating ACE2 Levels With COVID-19 |
Completed |
|
Jan/01/2022 |
Jan/21/2022 |
- Alternative id - 2021/5
- Interventions - Diagnostic Test: ACE serum levels
- Study type - Observational
- Study results - No Results Available
- Locations - The University of Jordan, Amman, Jordan
- Study designs - Observational Model: Cohort|Time Perspective: Cross-Sectional
- Enrollment - 261
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - ACE2 level
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NCT04766645
|
ACE2 Gender Differences in Stroke With COVID-19 |
Recruiting |
|
Jun/10/2021 |
Jan/01/2023 |
- Alternative id - FDG_Acegender_2021
- Interventions - Device: Robotic assisted intervention|Genetic: epigenetic analyses|Diagnostic Test: biochemical analyses
- Study type - Observational
- Study results - No Results Available
- Locations - Fondazione Don Carlo Gnocchi, Rome, Italy
- Study designs - Observational Model: Cohort|Time Perspective: Prospective
- Enrollment - 100
- Age - 18 Years to 90 Years (Adult, Older Adult)
- Outcome measures - Change in promoter methylation levels of ACE2|expression levels of miR-200c-3p in serum|serum levels of Angiotensin II, ACE2 and Vitamin D|Change in Modified Barthel Index (BI)|Changes in the Montreal Cognitive Assessment (MoCA)|Changes in the Cumulative Ilness Rating scale (CIRS)|Change in Fugl-Meyer Assessment of Motor Recovery after Stroke for Upper Extremity portion (FMA-UL)|Numerical Rating Scale (NRS)|Neuropathic Pain Four Questions (DN4)|change in Modified Ashworth Scale (MAS)|change in Motricity Index (MI)|hand grip strenght test|pinch grip strenght test|Change in Functional Ambulation Classification (FAC)|change in 10 Meter Walk Test (10MWT)|Change in Time Up And Go (TUG)|Change in Six-Minute Walking Test (6MWT)|Kinematic analysis
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NCT04335136
|
Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) as a Treatment for Patients With COVID-19 |
Completed |
Phase 2 |
Apr/30/2020 |
Dec/26/2020 |
- Alternative id - APN01-01-COVID19
- Interventions - Drug: RhACE2 APN01|Drug: Physiological saline solution
- Study type - Interventional
- Study results - Has Results
- Locations - Medizinische Universität Innsbruck, Innsbruck, Austria|Kaiser Franz Josef Spital, 4. Medizinische Abteilung mit Infektions- und Tropenmedizin, Wien, Austria|Medizinische Universität Wien, Wien, Austria|The National University Hospital, Rigshospitalet, Copenhagen, Denmark|Herlev Gentofte Hospital, Herlev, Denmark|Nordsjællands Hospital, Hillerød, Denmark|Hvidovre Hospital, Hvidovre, Denmark|Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany|Klinikum rechts der Isar, Technische Universität München, München, Germany|Regional State Budgetary Educational Institution "Clinical Hospital № 5, Barnaul", Barnaul, Russian Federation|State Healthcare Institution "State Clinical Hspital № 15 named after O.M. Filatov", Moscow, Russian Federation|Moscow State Budgetary Healthcare Institution "City Clinical Hospital №52 of Health Department of Moscow", Moscow, Russian Federation|Moscow State Budgetary Healthcare Institution "N.V. Sklifosovsky Research Institute for Emergency Medicine of Health Department of Moscow", Moscow, Russian Federation|Saint Petersburg SBHI City Hospital 38 named after N A Semashko, Pushkin, Russian Federation|Federal State Budgetary Educational Institution of Higher Education "Ryazan State Medical University named after I.P. Pavlov" HD RF, Ryazan, Russian Federation|Alexandrovskaya Hospital, Saint-Petersburg, Russian Federation|Saint-Petersburg State Budget Healthcare Institution City Hospital 15, Saint-Petersburg, Russian Federation|Federal State Budgetary Educational Institution of Higher Education " Saratov State Medical University named after V.I. Razumovsky" HD RF, Saratov, Russian Federation|Regional State Budgetary Healthcare Institution "Clinical Hospital №1", Smolensk, Russian Federation|State budgetary institution of Healthcare of Tver region "Regional clinical hospital", Tver, Russian Federation|Yaroslavl Regional Clinical Hospital for Military Veterans - International Centre for Gerontological Problems "Healthy Ageing", Yaroslavl, Russian Federation|Cambridge University Hospitals NHS Trust/University of Cambridge, Cambridge, United Kingdom
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
- Enrollment - 185
- Age - 18 Years to 80 Years (Adult, Older Adult)
- Outcome measures - All Cause-death or Invasive Mechanical Ventilation|Lactate Dehydrogenase (LDH) Level|Mortality|Ventilator-free Days (VFD)|Time to Death|Number of Responders, Defined as ≥2 Improvement in World Health Organization (WHO)'s 11-Point Score System at Days 7, 10, 14 and 28|Time to Hospital Discharge|Viral Ribonucleic Acid (RNA).|Time to a 2-point Decrease in WHO's 11-Point Score System|Number of Patients With Any Use of Invasive Mechanical Ventilation up to 28 Days or Hospital Discharge|Time to First Use of Invasive Mechanical Ventilation up to 28 Days or Hospital Discharge|PaO2/FiO2 Value|Modified Sequential Organ Failure Assessment Score (mSOFA Score, Total Score)|Lymphocyte Count|C-reactive Protein Levels|D-Dimer|Log-transformed Levels of LDH
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NCT04990557
|
CRISPR/Cas9-modified Human T Cell ( PD-1and ACE2 Knockout Engineered T Cells ) for Inducing Long-term Immunity in COVID-19 Patients |
Not yet recruiting |
Phase 1|Phase 2 |
Aug/01/2021 |
Nov/01/2022 |
- Alternative id - Novel Treatment for Covid-19
- Interventions - Drug: PD-1 and ACE2 Knockout T Cells
- Study type - Interventional
- Study results - No Results Available
- Locations -
- Study designs - Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 16
- Age - 18 Years to 70 Years (Adult, Older Adult)
- Outcome measures - Number of Participants With Adverse Events and/or Dose Limiting Toxicities as a Measure of Safety and Tolerability of Dose of PD-1 Knockout T Cells Using Common Terminology Criteria for Adverse Events (CTCAE v4.0) in Patients|Number of Patients With Overall Response to the reinfection|All cause mortality rate|Proportion of patients with upregulated inflammatory factors|Serum levels of IL-6,TNF,TLR3,CRP, ESR and Type I interferon|Absolute lymphocyte counts (CD4,CD8 and CD25+FOXP3+ Regulatory T)|Safety-Hematology
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NCT04416893
|
Part 2 on the Study Prevalence of SARS -Cov2 Carriage in Asymptomatic and Mildly-symptomatic Children (COVILLE2) (WHO) |
Withdrawn |
|
Nov/01/2020 |
Apr/01/2021 |
- Alternative id - COVILLE2
- Interventions - Diagnostic Test: RT-PCR SARS-Cov2|Diagnostic Test: Sars-Cov2 serology
- Study type - Observational
- Study results - No Results Available
- Locations -
- Study designs - Observational Model: Cohort|Time Perspective: Prospective
- Enrollment - 0
- Age - up to 15 Years (Child)
- Outcome measures - Proportion of asymptomatic children or children with mild respiratory symptoms|Cov2-SARS cases by age|Cov2-SARS cases by symptoms|Viral load|Presence of anti-SARS-CoV-2 antibodies (IgM and IgG) by the rapid serological test
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NCT04581161
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Proportional Open Ventilation (POV) Device and Its Efficacy in Managing Acute Respiratory Failure in COVID-19 Patients |
Recruiting |
Not Applicable |
Aug/28/2020 |
Oct/01/2020 |
- Alternative id - CR-RR-2020-004
- Interventions - Device: Life2000® Ventilator
- Study type - Interventional
- Study results - No Results Available
- Locations - Park Nicolette, Bloomington, Minnesota, United States
- Study designs - Allocation: Non-Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 10
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Life2000® Compared to HFNC (AIRVO)|PEEP level
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NCT04359329
|
Estrogen Patch for COVID-19 Symptoms |
Terminated |
Phase 2 |
Apr/20/2020 |
Jul/30/2020 |
- Alternative id - SBU-EstrogenPatch-COVID19
- Interventions - Drug: Estradiol patch
- Study type - Interventional
- Study results - No Results Available
- Locations - Stony Brook University Hospital, Stony Brook, New York, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 2
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Rate of Hospitalization|Rate of Transfer to Intensive Care Unit|Rate of Intubation|Rate of Death
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NCT04732468
|
COVID-19 Oral and Subcutaneous Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenovirus Platform in Healthy Volunteers in USA |
Active, not recruiting |
Phase 1 |
Feb/24/2021 |
Apr/01/2022 |
- Alternative id - COVID-4.005
- Interventions - Biological: hAd5-S-Fusion+N-ETSD (Suspension for injection)|Drug: hAd5-SFusion+ N-ETSD (Oral capsule)
- Study type - Interventional
- Study results - No Results Available
- Locations - Chan Soon - Shiong Institute for Medicine, El Segundo, California, United States|Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States
- Study designs - Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 26
- Age - 18 Years to 55 Years (Adult)
- Outcome measures - Incidence of MAAEs and SAEs|Incidence and severity of solicited local reactogenicity AEs|Incidence and severity of solicited systemic reactogenicity AEs|Incidence and severity of unsolicited AEs|Incidence of changes of laboratory safety examinations|Vital Sign - Temperature|Vital Sign - Heart rate|Vital Sign - Blood Pressure|Vital Sign - Respiratory Rate|GMFR in IgG titer|GMT of S-specific, RBD-specific, and N-specific antibodies|Percentage of subjects who seroconverted|GMFR in neutralizing antibody|GMT of neutralizing antibody|Seroconversion rate of neutralizing antibody|CD8+ T-Cell activity against SARS-CoV-2 S protein, RBD, and N protein|CD4+ T-Cell activity against SARS-CoV-2 S protein, RBD, and N protein
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NCT04375046
|
Recombinant Bacterial ACE2 Receptors -Like Enzyme of B38-CAP Could be Promising Treatment for COVID-19 Infection- and Its Inflammatory Complications Better Than Recombinant Human ACE2 |
Not yet recruiting |
Phase 1 |
Jul/01/2021 |
Oct/01/2021 |
- Alternative id - proposed by Mahmoud kazazzaz
- Interventions - Drug: Recombinant Bacterial ACE2 receptors -like enzyme of B38-CAP (rbACE2)
- Study type - Interventional
- Study results - No Results Available
- Locations -
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 24
- Age - 18 Years to 80 Years (Adult, Older Adult)
- Outcome measures - Time course of body temperature (fever)|Viral load over time|P/F ratio over time|Sequential organ failure assessment score(SOFA score) over time|Pulmonary Severity Index (PSI)|Image examination of chest over time|Proportion of subjects who progressed to critical illness or death|Time from first dose to conversion to normal or mild pneumonia|T-lymphocyte counts over time|C-reactive protein levels over time|Angiotensin II (Ang II) changes over time|Angiotensin 1-7 (Ang 1-7) changes over time|Angiotensin 1-5 (Ang 1-5) changes over time|Renin changes over time|Aldosterone changes over time|Angiotensin-converting enzyme (ACE) changes over time|Angiotensin-converting enzyme 2 (ACE2) changes over time|Interleukin 6 (IL-6) changes over time|Interleukin 8 (IL-8) changes over time|Soluble tumor necrosis factor receptor type II (sTNFrII) changes over time|Plasminogen activator inhibitor type-1 (PAI-1) changes over time|Von willebrand factor (vWF) changes over time|Tumor necrosis factor-α (TNF-α) changes over time|Soluble receptor for advanced glycation end products (sRAGE) changes over time|Surfactant protein-D (SP-D) changes over time|Angiopoietin-2 changes over time|Frequency of adverse events and severe adverse events
|
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NCT04382950
|
Combination of Recombinant Bacterial ACE2 Receptors -Like Enzyme of B38-CAP and Isotretinoin Could be Promising Treatment for COVID-19 Infection- and Its Inflammatory Complications |
Not yet recruiting |
Phase 1 |
Jul/01/2021 |
Oct/01/2021 |
- Alternative id - COV-2019 Treatment This is
- Interventions - Combination Product: Recombinant Bacterial ACE2 receptors -like enzyme of B38-CAP (rbACE2) plus Aerosolized 13 cis retinoic acid
- Study type - Interventional
- Study results - No Results Available
- Locations -
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 24
- Age - 18 Years to 60 Years (Adult)
- Outcome measures - Time course of body temperature (fever)|Viral load over time|P/F ratio over time|Sequential organ failure assessment score(SOFA score) over time|Pulmonary Severity Index (PSI)|Image examination of chest over time|Proportion of subjects who progressed to critical illness or death|Time from first dose to conversion to normal or mild pneumonia|T-lymphocyte counts over time|C-reactive protein levels over time|Angiotensin II (Ang II) changes over time|Angiotensin 1-7 (Ang 1-7) changes over time|Angiotensin 1-5 (Ang 1-5) changes over time|Renin changes over time|Aldosterone changes over time|Angiotensin-converting enzyme (ACE) changes over time|Interleukin 6 (IL-6) changes over time|Soluble tumor necrosis factor receptor type II (sTNFrII) changes over time|Plasminogen activator inhibitor type-1 (PAI-1) changes over time|Von willebrand factor (vWF) changes over time|Tumor necrosis factor-α (TNF-α) changes over time|Soluble receptor for advanced glycation end products (sRAGE) changes over time|Surfactant protein-D (SP-D) changes over time|Frequency of adverse events and severe adverse events
|
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NCT04640610
|
Angiotensin-converting Enzyme 2 (ACE2) Expression in Tonsils and Adenoids |
Withdrawn |
|
Jun/30/2021 |
Jun/30/2021 |
- Alternative id - APHP201032
- Interventions - Other: Storage of operating waste
- Study type - Observational
- Study results - No Results Available
- Locations - Hôpital Mondor, Créteil, France|Hôpital Bicêtre, Le Kremlin-Bicêtre, France|Hôpital Lariboisière, Paris, France|Hôpital Armand Trousseau, Paris, France|Hôpital Pitié Salpêtrière, Paris, France|HEGP, Paris, France|Hôpital Necker-Enfants Malades, Paris, France|Hôpital Bichat, Paris, France|Hôpital Tenon, Paris, France
- Study designs - Observational Model: Cohort|Time Perspective: Prospective
- Enrollment - 0
- Age - Child, Adult, Older Adult
- Outcome measures - Expression of ACE 2 receptor and TMPRSS2 serine protease|Location of ACE 2 receptor and TMPRSS2 serine protease
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NCT04658433
|
The Effect of Omega -3 Supplements on the Serum Levels of ACE/ACE2 Ratio as a Potential Key in Cardiovascular Disease and COVID-19; A Randomized Clinical Trial in the Covid-19 Uninfected Jordanian People |
Completed |
Not Applicable |
Mar/05/2021 |
Feb/10/2022 |
- Alternative id - 2020-PHA-22
- Interventions - Dietary Supplement: 300 mg of omega3-FA
- Study type - Interventional
- Study results - No Results Available
- Locations - Mahmoud S Abu-Samak, Amman, Jordan
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Prevention
- Enrollment - 100
- Age - 35 Years to 65 Years (Adult, Older Adult)
- Outcome measures - serum ACE levels|serum ACE2 levels|Lipid profile mg/dL
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NCT04324996
|
A Phase I/II Study of Universal Off-the-shelf NKG2D-ACE2 CAR-NK Cells for Therapy of COVID-19 |
Recruiting |
Phase 1|Phase 2 |
Feb/21/2020 |
Aug/31/2022 |
- Alternative id - ChongqingPublicHMC
- Interventions - Biological: NK cells,IL15-NK cells,NKG2D CAR-NK cells,ACE2 CAR-NK cells,NKG2D-ACE2 CAR-NK cells
- Study type - Interventional
- Study results - No Results Available
- Locations - Chongqing Public Health Medical Center, Chongqing, China
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 90
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Clinical response|Side effects in the treatment group
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NCT04632732
|
Apelin; ACE2 and Biomarkers of Alveolar-capillary Permeability in SARS-cov-2 (COVID-19). |
Completed |
|
Oct/26/2020 |
Oct/01/2021 |
- Alternative id - 2021-3862-APEL-COVID
- Interventions - Diagnostic Test: COVID-19 test|Diagnostic Test: Blood sampling
- Study type - Observational
- Study results - No Results Available
- Locations - Sherbrooke University, Sherbrooke, Quebec, Canada
- Study designs - Observational Model: Cohort|Time Perspective: Prospective
- Enrollment - 140
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Blood apelins-13/12, -17/16, -36|Blood angiotensin II|Blood Clara cell protein (CC16)|Blood interleukine-6 (IL-6)|Blood surfactant protein D (SP-D)|Plasma apelins degradation speed measurement by UPLC|Plasma ACE2 activity measurement by fluorometry|Plasma kallikrein activity measurement by fluorometry|Plasma neprilysin activity measurement by fluorometry|Plasma ras activity measurement by fluorometry|APACHEII|Oxygenation index|Mechanical ventilation|Pulmonary compliance (Dynamic, real-time, on ventilator device: Tidal volume / Plateau pressure - PEEP|Length of hospital stay|SOFA
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NCT04287686
|
Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) as a Treatment for Patients With COVID-19 |
Withdrawn |
Not Applicable |
Feb/01/2020 |
Apr/01/2020 |
- Alternative id - GIRH-APN01
- Interventions - Drug: Recombinant human angiotensin-converting enzyme 2 (rhACE2)
- Study type - Interventional
- Study results - No Results Available
- Locations - GCP Office of The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 0
- Age - 18 Years to 80 Years (Adult, Older Adult)
- Outcome measures - Time course of body temperature (fever)|Viral load over time|P/F ratio over time|Sequential organ failure assessment score(SOFA score) over time|Pulmonary Severity Index (PSI)|Image examination of chest over time|Proportion of subjects who progressed to critical illness or death|Time from first dose to conversion to normal or mild pneumonia|T-lymphocyte counts over time|C-reactive protein levels over time|Angiotensin II (Ang II) changes over time|Angiotensin 1-7 (Ang 1-7) changes over time|Angiotensin 1-5 (Ang 1-5) changes over time|Renin changes over time|Aldosterone changes over time|Angiotensin-converting enzyme (ACE) changes over time|Angiotensin-converting enzyme 2 (ACE2) changes over time|Interleukin 6 (IL-6) changes over time|Interleukin 8 (IL-8) changes over time|Soluble tumor necrosis factor receptor type II (sTNFrII) changes over time|Plasminogen activator inhibitor type-1 (PAI-1) changes over time|Von willebrand factor (vWF) changes over time|Tumor necrosis factor-α (TNF-α) changes over time|Soluble receptor for advanced glycation end products (sRAGE) changes over time|Surfactant protein-D (SP-D) changes over time|Angiopoietin-2 changes over time|Frequency of adverse events and severe adverse events
|
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NCT04865029
|
Estradiol and Progesterone in Hospitalized COVID-19 Patients |
Recruiting |
Phase 2 |
Jul/22/2021 |
May/01/2022 |
- Alternative id - 2020-939
- Interventions - Other: Placebo injection and placebo pill|Drug: Estradiol Cypionate 5 MG/ML|Drug: Progesterone 200 MG Oral Capsule
- Study type - Interventional
- Study results - No Results Available
- Locations - Tulane University Medical Center, New Orleans, Louisiana, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 120
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - The proportion of patients who achieve scores 1 or 2 on the 9-point World Health Organization (WHO) ordinal scale through day 28.|Length of hospital stay|Readmission|Duration of mechanical ventilation|Time of death|Cause of death|Change in biological markers ferritin, procalcitonin and troponin|Change in biological markers C-reactive protein and D-Dimer|Change in hypercoagulability marker fibrinogen|Change in tissue injury markers ALT, AST and LDH|Change in inflammation marker neutrophil:lymphocyte ratio|Grade 3 and 4 adverse events occurrence|Serious adverse events occurrence
|
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NCT04367402
|
COST (COvid STudio) ACTION: Study for the Evaluation of Specific Antibodies Anti Covid-19 Linked to Covid-19 Infection, Symptoms and Genetic Expression of ACE2 Polymorphisms in Patients (COST ACTION) |
Recruiting |
|
Mar/30/2020 |
Sep/01/2020 |
- Alternative id - 2020/ST/057
- Interventions - Other: BioMedomics COVID-19 IgM-IgG Rapid Test
- Study type - Observational
- Study results - No Results Available
- Locations - AO San Paolo, Milan, IT, Italy
- Study designs - Observational Model: Case-Control|Time Perspective: Retrospective
- Enrollment - 600
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Retrospective study on individuals with or without symptoms to verify the reliability of a prognostic/diagnostic test based on IgM/IgG analysis.|ACE2 expression in patients with COVID-19 infection
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NCT04961541
|
Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine |
Active, not recruiting |
Phase 1|Phase 2 |
Sep/08/2021 |
Mar/01/2022 |
- Alternative id - 2019nCoV-ICC-E-101
- Interventions - Biological: ICC Vaccine|Biological: qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant|Biological: SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant
- Study type - Interventional
- Study results - No Results Available
- Locations - Paratus Clinical Research - Canberra, Bruce, Australian Capital Territory, Australia|Paratus Clinical Research - Western Sydney, Blacktown, New South Wales, Australia|Northern Beaches Clinical Research, Brookvale, New South Wales, Australia|Paratus Clinical Research - Central Coast, Kanwal, New South Wales, Australia|Hunter Diabetes Centre, Merewether, New South Wales, Australia|University of the Sunshine Coast,Southbank, Brisbane, Queensland, Australia|University of the Sunshine Coast, Health Hub Morayfield, Morayfield, Queensland, Australia|University of the Sunshine Coast, Sippy Downs, Queensland, Australia|Austrials Pty Ltd - Taringa, Taringa, Queensland, Australia|Emeritus Research, Camberwell, Victoria, Australia
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Prevention
- Enrollment - 642
- Age - 50 Years to 70 Years (Adult, Older Adult)
- Outcome measures - Number of participants with solicited local and systemic AE's|Percentage of participants reporting all AE's|Percentage of participants with MAAE's, AESI's (including PIMMCs), SAEs|HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B strain(s) expressed as GMT|HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B strain(s) expressed as (GMFRPost/Pre)|HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B strain(s) expressed as SCR|Percentage of participants with a reciprocal HAI titer ≥ 40 expressed as SPR|HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B strain(s) expressed as GMTR|Microneutralization (MN50) antibody responses expressed as GMT|Microneutralization (MN50) antibody responses expressed as GMFR|Microneutralization (MN50) antibody responses expressed as SCR|Microneutralization (MN50) antibody responses expressed as GMTR|Serum IgG antibody concentrations as ELISA units to the SARS-CoV-2 spike protein expressed as GMEU|Serum IgG antibody concentrations as ELISA units to the SARS-CoV-2 spike protein expressed as GMFR|Serum IgG antibody concentrations as ELISA units to the SARS-CoV-2 spike protein expressed as SCR|Serum IgG antibody concentrations as ELISA units to the SARS-CoV-2 spike protein expressed as GMEUR|MN50 GMTs to the SARS-CoV-2 expressed as GMT|MN50 GMTs to the SARS-CoV-2 expressed as GMFR|MN50 GMTs to the SARS-CoV-2 expressed as SCR|MN50 GMTs to the SARS-CoV-2 expressed as GMTR
|
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NCT04591717
|
COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral-COVID-19 in Normal Healthy Volunteers |
Active, not recruiting |
Phase 1 |
Oct/19/2020 |
Nov/19/2021 |
- Alternative id - QUILT-COVID-19-hAd5-Vaccine
- Interventions - Biological: hAd5-S-Fusion+N-ETSD vaccine
- Study type - Interventional
- Study results - No Results Available
- Locations - Chan Soon - Shiong Institute for Medicine, El Segundo, California, United States|Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States
- Study designs - Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 34
- Age - 18 Years to 55 Years (Adult)
- Outcome measures - Incidence of MAAEs and SAEs|Incidence and severity of solicited local reactogenicity AEs|Incidence and severity of solicited systemic reactogenicity AEs|Incidence and severity of unsolicited AEs|Incidence of abnormal changes of laboratory safety examinations|Vital Signs - Fever|Vital Signs - Tachycardia|Vital Signs - Bradycardia|Vital Signs - Hypertension|Vital Signs - Hypotension|Vital Signs - Respiratory Rate|GMFR in IgG titer|GMT of S-specific, RBD-specific, and N-specific antibodies against 2019 novel coronavirus|Percentage of subjects who seroconverted|GMFR in neutralizing antibody|GMT|Seroconversion rate of neutralizing antibody|CD8+ T-Cell activity against SARS-CoV-2 S protein, RBD, and N protein|CD4+ T-Cell activity against SARS-CoV-2 S protein, RBD, and N protein
|
