|
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
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NCT04483830
|
Suloexide in the Treatment of Early Stages of COVID-19 |
Completed |
Phase 2|Phase 3 |
Jun/05/2020 |
Sep/07/2020 |
- Alternative id - Clidm/Vas/2020-05-01
- Interventions - Drug: Sulodexide|Drug: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Clinedem, San Luis Rio Colorado, Sonora, Mexico
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment
- Enrollment - 243
- Age - 40 Years to 80 Years (Adult, Older Adult)
- Outcome measures - hospital care|days of hospital care|days of need suplemental oxigen|serum level of d-dimmer|serum level of creatinine|thromboembolic event|need for mechanical ventilation
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NCT04932876
|
The Response of the Immune System of Patients With End Stage Kidney Disease on Dialysis and Kidney Transplant Recipients Vaccinated for COVID-19 |
Recruiting |
|
Apr/24/2021 |
Mar/01/2023 |
- Alternative id - RESCOMUOI82152
- Interventions - Biological: SARS - COV 2 VACCINE
- Study type - Observational
- Study results - No Results Available
- Locations - Evangelia Ntounousi, Ioannina, Epirus, Greece
- Study designs - Observational Model: Case-Control|Time Perspective: Prospective
- Enrollment - 100
- Age - 18 Years to 90 Years (Adult, Older Adult)
- Outcome measures - Efficacy of the vaccine|Complications caused by the vaccine
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NCT03348670
|
Discovery Stage COVID-19 Antigen Presentation Therapeutic Biologics Mix to Treat COVID-19 Virus Infection |
Active, not recruiting |
Early Phase 1 |
Oct/20/2021 |
Mar/28/2022 |
- Alternative id - IND158083|FWA00015357|IRB00009424|IORG0007849|NDA216636|BLA761273
- Interventions - Biological: CoronaVac® plus TICE® BCG Mix for Intradermal Injection
- Study type - Interventional
- Study results - No Results Available
- Locations - MIDI Clinical Trial Sites -c/o- Dr. Han Xu - Sponsor / Investigators / Physicians / Laboratories Operation Site, Rockville, Maryland, United States
- Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 20
- Age - 24 Years to 74 Years (Adult, Older Adult)
- Outcome measures - Negative testing COVID-19 by standard RT-PCR assay
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NCT05130710
|
The Impact of COVID-19 Pandemic on Clinical Presentation and Staging of Gastric Cancer |
Completed |
|
Feb/25/2020 |
Feb/25/2021 |
- Alternative id - IR.TUMS.IKHC.REC.1399.414
- Interventions - Procedure: staging laparoscopy
- Study type - Observational
- Study results - No Results Available
- Locations - Cancer institute, Imam Khomeini Hospital Complex, Tehran, Iran, Islamic Republic of
- Study designs - Observational Model: Case-Control|Time Perspective: Prospective
- Enrollment - 80
- Age - Child, Adult, Older Adult
- Outcome measures - presence of peritoneal seeding|presence of peri-gastric lymph node involvement
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NCT04539262
|
Study in Participants With Early Stage Coronavirus Disease 2019 (COVID-19) to Evaluate the Safety, Efficacy, and Pharmacokinetics of Remdesivir Administered by Inhalation |
Completed |
Phase 1|Phase 2 |
Sep/14/2020 |
Mar/22/2021 |
- Alternative id - GS-US-553-9020
- Interventions - Drug: Remdesivir (RDV)|Drug: Placebo
- Study type - Interventional
- Study results - Has Results
- Locations - The Institute for Liver Health, Mesa, Arizona, United States|The Institute for Liver Health, Tucson, Arizona, United States|Franco Felizarta, MD, Bakersfield, California, United States|Aurora FDRC Inc., Costa Mesa, California, United States|Elevated Health, Huntington Beach, California, United States|Cedars-Sinai Medical Center, Los Angeles, California, United States|Western Clinical Research, Placentia, California, United States|UC Davis Health/Medical Center, Sacramento, California, United States|Bradenton Research Center, Inc., Bradenton, Florida, United States|Integrity Clinical Research, LLC, Doral, Florida, United States|Holy Cross Hospital, Fort Lauderdale, Florida, United States|Evolution Clinical Trials, Inc., Hialeah Gardens, Florida, United States|Research in Miami, Inc., Hialeah, Florida, United States|Optimus U Corporation, Miami, Florida, United States|L & C Professional Medical Research Institute, Miami, Florida, United States|Westchester Research Center at Westchester General Hospital, Miami, Florida, United States|MedBio Trials, Miami, Florida, United States|Nuovida Research Center, Corp, Miami, Florida, United States|IMIC Inc, Palmetto Bay, Florida, United States|Triple O Research Institute, PA, West Palm Beach, Florida, United States|Family Care Research, Boise, Idaho, United States|CTU Covid Research Center, New Orleans, Louisiana, United States|STAT Research, Vandalia, Ohio, United States|Inquest Clinical Research, Baytown, Texas, United States|DFW Clinical Research, Dallas, Texas, United States|Baylor Research Institute, Dallas, Texas, United States|PCP for Life-Tidwell, Houston, Texas, United States|Providence Regional Medical Center Everett, Everett, Washington, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
- Enrollment - 156
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Time-weighted Average Change From Baseline in Nasopharyngeal Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Through Day 7|Time-weighted Average Change From Baseline in Oropharyngeal SARS-CoV-2 Viral Load Through Day 7|Time-weighted Average Change From Baseline in Saliva SARS-CoV-2 Viral Load Through Day 7|Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)|Percentage of Participants With Treatment-Emergent Laboratory Abnormalities as Per Severity Grade|Percentage of Participants With Treatment-Emergent Adverse Events Leading to Study Treatment Discontinuation|Number of Participants With All-Cause Medically Attended Visits (MAVs) or Death by Day 28|Number of Participants With COVID-19 Related MAVs or Death by Day 28|Number of Participants With Hospitalization by Day 28|Pharmacokinetic (PK) Parameter: AUC0-24h of Remdesivir (RDV) and Its Metabolites (GS-441524 and GS-704277) in Parts A and B|PK Parameter: AUClast of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B|PK Parameter: CLss/F of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B|PK Parameter: t1/2 of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B|PK Parameter: Vz/F of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B|PK Parameter: Cmax of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B|PK Parameter: Tmax of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B|PK Parameter: Clast of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B|PK Parameter: Tlast of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B|PK Parameter: AUCtau of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B|PK Parameter: λz of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B|PK Parameter: Ctau of RDV and Its Metabolites (GS-441524 and GS-704277) in Parts A and B|Change in Nasopharyngeal SARS-CoV-2 Viral Load From Baseline to Day 5|Change in Oropharyngeal SARS-CoV-2 Viral Load From Baseline to Day 5|Change in Saliva SARS-CoV-2 Viral Load From Baseline to Day 5|Change in Nasopharyngeal SARS-CoV-2 Viral Load From Baseline to Day 7|Change in Oropharyngeal SARS-CoV-2 Viral Load From Baseline to Day 7|Change in Saliva SARS-CoV-2 Viral Load From Baseline to Day 7|Change in Nasopharyngeal SARS-CoV-2 Viral Load From Baseline to Day 14 in Parts A and B|Change in Oropharyngeal SARS-CoV-2 Viral Load From Baseline to Day 14 in Parts A and B|Change in Saliva SARS-CoV-2 Viral Load From Baseline to Day 14 in Parts A and B|Time to Negative Nasopharyngeal SARS-CoV-2 Polymerase Chain Reaction (PCR)|Time to Negative Oropharyngeal SARS-CoV-2 Polymerase Chain Reaction (PCR)|Time to Negative Saliva SARS-CoV-2 Polymerase Chain Reaction (PCR)|Time to Alleviation (Mild or Absent) of Baseline COVID-19 Symptoms as Reported on the COVID-19 Adapted InFLUenza Patient-Reported Outcome (FLU-PRO©) Questionnaire in Part C
|
|
NCT04405843
|
Efficacy of Ivermectin in Adult Patients With Early Stages of COVID-19 (EPIC Trial) |
Completed |
Phase 2|Phase 3 |
Jul/14/2020 |
Dec/21/2020 |
- Alternative id - ScDi823|IVE-PA
- Interventions - Drug: Ivermectin Oral Product|Drug: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Centro de Estudios en Infectología Pediátrica, Cali, Valle, Colombia
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 476
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Time to event|Clinical condition on day 2|Clinical condition on day 5|Clinical condition on day 8|Clinical condition on day 11|Clinical condition on day 15|Clinical condition on day 21|Proportion of subjects with additional care|Proportion of subjects who die|Duration of additional care|Adverse events|Proportion of subjects who discontinue intervention|Duration of fever
|
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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
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NCT04789447
|
Initial CT Findings and CO-RADS Stage in COVID-19 |
Completed |
|
Mar/04/2021 |
May/06/2021 |
- Alternative id - CT-19
- Interventions -
- Study type - Observational
- Study results - No Results Available
- Locations - Sultan Abdülhamid Han Training and Research Hospital, Istanbul, Turkey|Sultan Abdülhamid Han Training and Research Hospital, Istanbul, Turkey
- Study designs - Observational Model: Cohort|Time Perspective: Retrospective
- Enrollment - 895
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - mortality|need for intensive care|need for intenvasive mechanical ventilation
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NCT05033145
|
Study on Safety and Clinical Efficacy of AZVUDINE in Initial Stage COVID-19 Patients (SARS-CoV-2 Infected) |
Not yet recruiting |
Phase 3 |
Oct/01/2021 |
Jul/01/2022 |
- Alternative id - FNC IGZ-2
- Interventions - Drug: AZVUDINE|Drug: AZVUDINE placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Clinical Research Unit / High Complexity Center (CRU/HCC) / Galzu Institute, Campos Dos Goytacazes, Rio De Janeiro, Brazil|Hospital Moacyr Gomes de Azevedo, Cambuci, RJ, Brazil|Hospital Santa Casa de Misericórdia de Campos, Campos Dos Goytacazes, RJ, Brazil|Unidade de Pesquisa Clínica / Centro de Alta Complexidade, Campos dos Goytacazes, RJ, Brazil|Unidade Pré Hospitalar São José, Campos Dos Goytacazes, RJ, Brazil|Hospital de Itaocara, Itaocara, RJ, Brazil|Hospital Armando Vidal, São Fidelis, RJ, Brazil
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 312
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Hospitalized patients proportion during the study|Proportion of participants with clinical evolution of cure during the study|Improvement of participant clinical status|Severity and duration of clinical symptoms|Assessment of renal function biochemical markers (serum creatinine and calculated glomerular filtration rate)|Assessment of liver function biochemical markers (AST/TGO, ALT/TGP, ALP, GGT, BIL total, and direct BIL)|Evaluation of time to negative conversion of SARS-CoV-2 viral load by RT-PCR|Evaluation of the number of cycles for the detection of SARS-CoV-2 viral load by RT-PCR and application of the standard curve for calculating viral load.|Analysis of the relationship between the calculated viral load and the clinical evolution of the participants in experimental (FNC) and PLACEBO groups.|Evaluation of drug interaction events.|Overall mortality assessment.|Assessment of adverse events frequency.|Assessment of adverse events intensity.|Assessment of unexpected adverse events frequency.|Assessment of unexpected adverse events intensity.|Assessment of serious adverse events frequency.|Assessment of serious adverse events intensity.|Evaluation of the tolerability of azvudine in the 5 mg regimen orally QD up to 14 days.|Assessment of adherence of azvudine in the 5 mg regimen orally QD up to 14 days.|Time of use of azvudine in the 5 mg regimen orally QD up to 14 days.
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NCT04424056
|
A Trial Using ANAKINRA, TOCILIZUMAB Alone or in Association With RUXOLITINIB in Severe Stage 2b and 3 of COVID19-associated Disease |
Not yet recruiting |
Phase 3 |
Sep/01/2020 |
Nov/01/2022 |
- Alternative id - 2020-23
- Interventions - Drug: Anakinra +/- Ruxolitinib (stages 2b/3)|Drug: Anakinra and Ruxolitinib (Advanced stage 3)|Drug: Tocilizumab +/- ruxolitinib (stages 2b/3)|Drug: Tocilizumab and Ruxolitinib (Advanced stage 3)|Other: Standard of care
- Study type - Interventional
- Study results - No Results Available
- Locations - Assistance Publique Hôpitaux de Marseille, Marseille, France
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 216
- Age - 18 Years to 75 Years (Adult, Older Adult)
- Outcome measures - Ventilation free days at D28
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NCT04784481
|
Ivermectin Reproposing for Mild Stage COVID-19 Outpatients |
Completed |
Phase 1|Phase 2 |
Sep/20/2020 |
Jan/18/2021 |
- Alternative id - 5077-410-CH2020
- Interventions - Drug: Ivermectin
- Study type - Interventional
- Study results - No Results Available
- Locations - SI.PRO.SA, Ministerio de Salud Pública, Tucumán, Argentina
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 254
- Age - 18 Years to 75 Years (Adult, Older Adult)
- Outcome measures - Proportion test|Odd Ratio|Odd Ratio and logistic regression test
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NCT04507867
|
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III |
Completed |
Not Applicable |
Sep/07/2020 |
Apr/10/2021 |
- Alternative id - 202036
- Interventions - Dietary Supplement: Nutritional support system (NSS)|Other: Conventional nutritional support designed by hospital nutritionists
- Study type - Interventional
- Study results - Has Results
- Locations - ISSEMYM "Arturo Montiel Rojas" Medical Center, Toluca de Lerdo, Mexico State, Mexico
- Study designs - Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: Triple (Participant, Care Provider, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 80
- Age - 30 Years to 75 Years (Adult, Older Adult)
- Outcome measures - Overall Survival|Overall Mortality at Day 40|Survival in Intubated Patients at Day 40|Mortality in Intubated Patients at Day 40|Progression to Mechanical Ventilation Assistance|Participants With Normal Bristol Scale at Day 3|Hidric Balance on Day 3|Oxigen Saturation >90% on Day 3|PHQ-9 Test|Oxigen Flow (Intragroup)|qSOFA at Day 3|Number of Defectations on Day 3|Number of Participants With Distension on Day 3
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NCT04941105
|
Impact of PCSK9 Inhibition on Clinical Outcome in Patients During the Inflammatory Stage of the COVID-19 |
Recruiting |
Phase 3 |
Jun/01/2021 |
Jul/31/2021 |
- Alternative id - IMPACT-SIRIO 5
- Interventions - Drug: Evolocumab|Drug: Saline solution
- Study type - Interventional
- Study results - No Results Available
- Locations - Antoni Jurasz University Hospital No. 1, Bydgoszcz, Poland
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 60
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Need for intubation|Death from any cause|Change in serum interleukin-6 concentration from day 0 to day 3|Change in serum interleukin-6 concentration from day 0 to day 7|The time of invasive mechanical ventilation|The time with Non-invasive mechanical ventilation (NIV) or High-flow nasal cannula (HFNC)|The time with oxygen therapy|The duration of hospitalization|Discontinuation of oxygen therapy before discharge
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NCT04366232
|
Efficacy of Intravenous Anakinra and Ruxolitinib During COVID-19 Inflammation |
Terminated |
Phase 2 |
Aug/19/2020 |
Oct/02/2020 |
- Alternative id - 2020-CHITS-003|2020-001963-10
- Interventions - Drug: Anakinra alone (stages 2b/3)|Drug: Anakinra and Ruxolitinib (overcome stage 3)|Other: Standard of care
- Study type - Interventional
- Study results - No Results Available
- Locations - AP-HM, Hôpital de la Conception, Marseille, Bouches-du-Rhône, France|Hôpital Sainte-Musse, Toulon, VAR, France|Sainte Anne Teaching Military Hospital, Toulon, Var, France
- 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 - Biological criteria|Duration of oxygen therapy (days)|Number of intensive care units admissions|Number of days in intensive care units|Mortality rate|Total number of days in hospital|Organ failure score modification (Sepsis-related Organ Failure Assessment (SOFA) score)|Number of bacterial and/or fungal sepsis
|
