Covid 19 Clinical Trials

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).

NCT04472728 Covid-19 SARS-CoV2 Drug: BIO101 Drug: Placebo

Primary Outcomes

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 days

Description: 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 days

Description: • 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 days

Secondary Outcomes

Description: • 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 days

Description: • Inflammatory markers including: IL 6 TNFα D-dimer

Measure: Interim analysis; indication of activity of BIO101: Inflammatory markers

Time: 28 days

Description: • 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: Population-Pharmacokinetics study (pop-PK)

Measure: Additional secondary endpoint for final analysis: Population Pharmacokinetics study (pop-PK)

Time: 28 days

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation

Correlated Drug Terms (2)

Correlated MeSH Terms (3)

Correlated HPO Terms (0)

Clinical Trials

1 Adaptive Design Phase 2 to 3, Randomized, Double-blind, to Evaluate Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of BIO101 in the Prevention of the Respiratory Deterioration in Hospitalized COVID-19 Patients

NCT04472728 Covid-19 SARS-CoV2 Drug: BIO101 Drug: Placebo

Primary Outcomes

Secondary Outcomes

No related HPO nodes (Using clinical trials)