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Testing the Efficacy and Safety of BIO101 for the Prevention of Respiratory Deterioration in COVID-19 Patients

NCT04472728 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 238

Last updated 2023-05-15

No results posted yet for this study

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).

Conditions

Interventions

DRUG

BIO101

BIO101 capsules

DRUG

Placebo

placebo capsules

Sponsors & Collaborators

  • Biophytis

    lead INDUSTRY

Principal Investigators

  • Capucine Morelot-Panzini, MD · Département R3S GHU APHP-Sorbonne Université, Pitié Salpetrière

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-26
Primary Completion
2022-06-06
Completion
2022-09-30
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Brazil
  • France
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04472728 on ClinicalTrials.gov