Testing the Efficacy and Safety of BIO101 for the Prevention of Respiratory Deterioration in COVID-19 Patients
Status:
Recruiting
Trial end date:
2021-09-01
Target enrollment:
Participant gender:
Summary
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).