|drug3361||Tenofovir/ Emtricitabine ( 300 mg / 200 mg daily during 60 days) + Personal Protective Equipment (PPE) Wiki||1.00|
|drug2492||Placebo (1 tablet daily during 60 days) + Personal Protective Equipment (PPE) Wiki||1.00|
|drug2511||Placebo Administration Wiki||0.50|
|D045169||Severe Acute Respiratory Syndrome NIH||0.04|
|D018352||Coronavirus Infections NIH||0.03|
There is one clinical trial.
This phase I trial evaluates the side effects and best dose of COH04S1, a synthetic modified vaccinia Ankara (MVA)-based SARS-CoV-2 vaccine, for the prevention of COVID-19. COVID-19 is caused by the SARS-CoV-2 virus. SARS-CoV-2 has demonstrated the capability to spread rapidly, leading to significant impacts on healthcare systems and causing societal disruption. COH04S1 was created by placing small pieces of SARS-CoV-2 DNA (the chemical form of genes) into synthetic MVA, which may be able to induce immunity (the ability to recognize and fight against an infection) to SARS-CoV-2. The purpose of this study is to determine the safety and the optimal dose of the COH04S1 vaccine.
Description: Evaluated based on the Division of Microbiology and Infectious Diseases criteria.Measure: Incidence of adverse events Time: Up to 365 days
Description: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-specific IgA, IgG, and IgM measured in serum and saliva by enzyme-linked immunosorbent assay.Measure: Humoral immunity Time: During 1 year of observation
Description: Level of neutralizing antibodies and percentage of participants with neutralizing antibodies as determined by a pseudotyped lentivirus-S assay.Measure: Level of SARS-CoV-2-specfic neutralizing antibodies Time: Up to 365 days
Description: SARS-CoV-2-specific IFN-gamma, TNF-alpha, IL-2, IL-4, IL6, IL-13 cytokine levels will be measured to assess Th1 vs Th2 polarization.Measure: Th1 vs Th2 polarization Time: Up to 365 days
Description: Percentage of participants with T cell immunity to SARS-CoV-2 S and N proteins post vaccination.Measure: SARS-CoV-2- antigen specific T cell responses to the COH04S1 vaccine Time: Up to 365 days
Description: Percentage of participants with activated/cycling and memory phenotype markers on the surface of SARS-CoV-2- specific T cells elicited as a result of the COH04S1 vaccinationMeasure: Evolution of activated/cycling and memory phenotype markers on the surface of SARS-CoV-2- specific T cells elicited as a result of the COH04S1 vaccination Time: Up to 365 days
Description: Immunogenicity will be evaluated based on the percentage of participants with SARS-CoV-2 S and N antibodies and T cell immunity post vaccination.Measure: Comparison of one vaccine injection vs two vaccine injections for immunogenicity Time: Up to 365 days
Description: Safety will be evaluated based on the Division of Microbiology and Infectious Diseases criteria.Measure: Comparison of one vaccine injection vs two vaccine injections for adverse events Time: Up to 365 days
Description: Number of participants with incidental COVID-19 will be determined during the study follow-up period and correlated with vaccination regimen and placebo.Measure: Incidence of coronavirus 2019 (COVID-19) Time: Up to 365 days
Description: Number of participants with mild versus severe COVID-19 will be determined within each vaccine dose level and regimen.Measure: Severity of COVID-19 and resolution Time: Up to 365 days
Description: Number of participants with incidental COVID-19 will be determined to provide initial data on acquired COVID-19 in the placebo group as an exploratory objective.Measure: Incidence of COVID-19 in placebo group Time: Up to 365 days
Data processed on January 01, 2021.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports