Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
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There is one clinical trial.
The COVA clinical study is a global multicentric, double-blind, placebo-controlled, group sequential and adaptive 2 parts phase 2-3 study targeting in patients with SARS-CoV-2 pneumonia. Part 1 is a Phase 2 exploratory Proof of Concept (PoC) study to provide preliminary data on the activity, safety and tolerability of BIO101 in the target population. Part 2 is a phase 3 pivotal randomized study to provide further evidence of safety and efficacy of BIO101 after 28 days of double-blind dosing. BIO101 is the investigational new drug that activates the Mas receptor (MasR) through the protective arm of the Renin Angiotensin System (RAS).
Description: For interim analysis intended to obtain indication of activity of BIO101. Primary endpoint: • Proportion of subjects with negative events, of either of the following: All-cause mortality Respiratory failure, defined as any of the following: Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage) Requiring ECMO Requiring high-flow oxygen
Measure: End-of-Part 1 interim analysis: Proportion of subjects with all cause mortality or with respiratory failure. Time: up to 28 daysDescription: For sample size re-assessment for part 2, time frame - up to 28 days: • Proportion of participants with negative events, of either of the following: All-cause mortality Respiratory failure, defined as any of the following: Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage) Requiring high-flow oxygen
Measure: For part-2 sample size interim analysis: Proportion of subjects with all cause mortality or with respiratory failure. Time: up to 28 daysDescription: • Proportion of participants with of subjects with negative events, of either of the following. All-cause mortality Respiratory failure, defined as any of the following: Mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage) Requiring ECMO Requiring high-flow oxygen
Measure: For the final analysis: Proportion of subjects with all cause mortality or respiratory failure. Time: up to 28 daysDescription: • SpO2/FiO2
Measure: Interim analysis; indication of activity of BIO101: Oxygen saturation by pulse oximetry (SpO2) SpO2 / Fraction of inspired oxygen (FiO2) ratio Time: 28 daysDescription: • Inflammatory markers including: IL 6 TNFα D-dimer
Measure: Interim analysis; indication of activity of BIO101: Inflammatory markers Time: 28 daysDescription: • Renin Angiotensin System biomarkers: Angiotensin 2 Angiotensin-converting enzyme (ACE) levels
Measure: Interim analysis; indication of activity of BIO101: Renin Angiotensin System biomarkers Time: 28 daysDescription: Proportion of participants with events of all-cause mortality Proportion of participants with 'positive' events: o official discharge from hospital care by the department due to improvement in patient condition (self-discharge by patient is not considered a positive event) Proportion of participants with events of respiratory failure, defined as any of the following: Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage) Requiring ECMO Requiring high-flow oxygen
Measure: Key secondary endpoint for final analysis: Proportion of participants with positive or negative events Time: 28 daysDescription: Oxygen saturation in arterial blood, measured by pulse-oximetry (SpO2) SpO2/FiO2 Proportion of participants with CPAP/BiPAP events, defined as requiring CPAP/BiPAP in participants entering the study on low flow oxygen)
Measure: Additional secondary endpoints for final analysis: Respiratory function Time: 28 daysDescription: For participants who experienced a positive event: proportion of participants with with sustained positive outcome (to asesss durability of effect after those participants discontinued study medication). Time to event: official discharge from hospital care due to improvement
Measure: Additional secondary endpoints for final analysis:proportion of patients who experienced positive event Time: 28 daysDescription: Time to events, of either of the following: All-cause mortality Respiratory failure, defined as any of the following: Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage); Requiring ECMO; Requiring high-flow oxygen • Proportion of participants with CPAP/BiPAP events, defined as requiring CPAP/BiPAP in participants entering the study on low flow oxygen)
Measure: Additional secondary endpoints for final analysis:proportion of patients who experienced negative events Time: 28 daysDescription: National Early Warning Score 2 (NewS2): scores: 0-7
Measure: Additional secondary endpoint for final analysis: The National Early Warning Score 2 (NewS2): Time: 28 daysDescription: Cmax: Peak Plasma concentration
Measure: Additional secondary endpoint for final analysis: Population Pharmacokinetics study (pop-PK) Time: 1dayDescription: tmax: Time to reach peak plasma concentration
Measure: Additional secondary endpoint : Population Pharmacokinetics study (pop-PK) Time: 1 dayDescription: AUC: Area under the plasma concentration versus time curve
Measure: Secondary endpoint: Population Pharmacokinetics study (pop-PK) Time: 1 dayAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
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