Clinical Trials Logo
  1. Home
  2. Other
  3. NCT04564716

Clinical Trial of Efficacy, Safety, and Immunogenicity of Gam-COVID-Vac Vaccine Against COVID-19 in Belarus

Covid19 Clinical Trial

Official title:
Сlinical Trial of Efficacy, Safety and Immunogenicity of Combined Vector Vaccine Gam-COVID-Vac in SARS-СoV-2 Infection Prophylactic Treatment in Republic of Belarus

Clinical Trial Summary

Randomized, double-blind (blinded for the trial subject and the study physician), placebo controlled, multi-center clinical trial in parallel assignment of efficacy, immunogenicity, and safety of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults in the SARS-СoV-2 infection prophylactic treatment.

Clinical Trial Description

Overall of 110 volunteers aged 18 to 60 should be screened taking into account possible early departure from the study. It is supposed that 100 subjects will complete all screening procedures and will be randomized in a 3:1 ratio into two groups: a control group (using placebo, 25 subjects) and a study group (using Gam-COVID-Vac Combined Vector Vaccine to Prevent Coronavirus Infection Caused by SARS-CoV-2", 75 subjects). The duration of participation in the study for one subject will be 180±14 days after the first dose of IMP/placebo, during which each subject will undergo a screening visit and five face-to-face visits to the doctor-researcher. Intramuscular injection of IMP or placebo will be carried out on vaccination visits N 1 and N 2 (Day 0 and Day 21±2). Further observation visits No 3, 4, 5 will be conducted on days 28±2, 42±2 and 180±14 respectively. It is allowed to conduct observation visits No. 3, 4 via telephone contact (TC). During the monitoring visits, all subjects of the study will be assessed on key vital indicators and data will be collected on changes in the status and well-being of the subjects since the previous visit. The duration of participation in the study for one subject will be 180±14 days after the first dose of IMP/placebo, during which each subject will undergo a screening visit and five observation visits. Intramuscular injection of IMP or placebo will be carried out on vaccination visits N 1 and N 2 (Day 0 and Day 21±2). Further observation visits No 3, 4, 5 will be conducted on days 28±2, 42±2 and 180±14 respectively. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04564716
Study type Interventional
Source Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Contact
Status Active, not recruiting
Phase Phase 3
Start date September 28, 2020
Completion date April 10, 2021
View Details
See also
  Status Clinical Trial Phase
Completed NCT05047692 - Safety and Immunogenicity Study of AdCLD-CoV19-1: A COVID-19 Preventive Vaccine in Healthy Volunteers Phase 1
Recruiting NCT04395768 - International ALLIANCE Study of Therapies to Prevent Progression of COVID-19 Phase 2
Completed NCT04506268 - COVID-19 SAFE Enrollment N/A
Completed NCT04508777 - COVID SAFE: COVID-19 Screening Assessment for Exposure
Terminated NCT04555096 - A Trial of GC4419 in Patients With Critical Illness Due to COVID-19 Phase 2
Completed NCT04961541 - Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine Phase 1/Phase 2
Active, not recruiting NCT04546737 - Study of Morphological, Spectral and Metabolic Manifestations of Neurological Complications in Covid-19 Patients N/A
Terminated NCT04581915 - PHRU CoV01 A Trial of Triazavirin (TZV) for the Treatment of Mild-moderate COVID-19 Phase 2/Phase 3
Completed NCT04494646 - BARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19) Phase 2
Not yet recruiting NCT04543006 - Persistence of Neutralizing Antibodies 6 and 12 Months After a Covid-19 N/A
Terminated NCT04542993 - Can SARS-CoV-2 Viral Load and COVID-19 Disease Severity be Reduced by Resveratrol-assisted Zinc Therapy Phase 2
Completed NCT04532294 - Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants Phase 1
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Not yet recruiting NCT04527211 - Effectiveness and Safety of Ivermectin for the Prevention of Covid-19 Infection in Colombian Health Personnel Phase 3
Completed NCT04537663 - Prevention Of Respiratory Tract Infection And Covid-19 Through BCG Vaccination In Vulnerable Older Adults Phase 4
Completed NCT04387292 - Ocular Sequelae of Patients Hospitalized for Respiratory Failure During the COVID-19 Epidemic N/A
Not yet recruiting NCT05038449 - Study to Evaluate the Efficacy and Safety of Colchicine Tablets in Patients With COVID-19 N/A
Completed NCT04979858 - Reducing Spread of COVID-19 in a University Community Setting: Role of a Low-Cost Reusable Form-Fitting Fabric Mask N/A
Completed NCT04610502 - Efficacy and Safety of Two Hyperimmune Equine Anti Sars-CoV-2 Serum in COVID-19 Patients Phase 2
Active, not recruiting NCT06042855 - ACTIV-6: COVID-19 Study of Repurposed Medications - Arm G (Metformin) Phase 3