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BIO101 for Coronavirus (COVA Trial)

Phase 2 & 3
Waitlist Available
Led By Capucine Morelot-Panzini, MD
Research Sponsored by Biophytis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

COVA Trial Summary

This trial is testing an investigational new drug to see if it is safe and effective in treating patients with SARS-CoV-2 pneumonia. The trial is divided into two parts, with the first part being an exploratory study to gather preliminary data and the second part being a larger study to provide more evidence of the safety and efficacy of the drug.

Eligible Conditions
  • COVID-19
  • Coronavirus

COVA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
End-of-Part 1 interim analysis: Proportion of subjects with all cause mortality or with respiratory failure.
For part-2 sample size interim analysis: Proportion of subjects with all cause mortality or with respiratory failure.
For the final analysis: Proportion of subjects with all cause mortality or respiratory failure.
Secondary outcome measures
Additional secondary endpoint : Population Pharmacokinetics study (pop-PK)
Additional secondary endpoint for final analysis: Population Pharmacokinetics study (pop-PK)
Additional secondary endpoint for final analysis: The National Early Warning Score 2 (NewS2)
+10 more

COVA Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BIO101Experimental Treatment1 Intervention
BIO101 350 mg bid
Group II: PlaceboPlacebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BIO101
2018
Completed Phase 2
~240

Find a Location

Who is running the clinical trial?

BiophytisLead Sponsor
2 Previous Clinical Trials
451 Total Patients Enrolled
Capucine Morelot-Panzini, MDPrincipal InvestigatorDépartement R3S GHU APHP-Sorbonne Université, Pitié Salpetrière

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
TrialsJournal
Testing the Efficacy and Safety of BIO101, for the Prevention of Respiratory Deterioration, in Patients with COVID-19 Pneumonia (COVA Study): A Structured Summary of a Study Protocol for a Randomised Controlled Trial
Dioh, W., M. Chabane, C. Tourette, A. Azbekyan, C. Morelot-Panzini, L. A. Hajjar, M. Lins, et al.. 2021. “Testing the Efficacy and Safety of BIO101, for the Prevention of Respiratory Deterioration, in Patients with COVID-19 Pneumonia (COVA Study): A Structured Summary of a Study Protocol for a Randomised Controlled Trial”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-020-04998-5.
clinicaltrials.govStudy
Testing the Efficacy and Safety of BIO101 for the Prevention of Respiratory Deterioration in COVID-19 Patients
2020. "Testing the Efficacy and Safety of BIO101 for the Prevention of Respiratory Deterioration in COVID-19 Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04472728.
~51 spots leftby Apr 2025
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