Efficacy and Safety of BIO101 in the Prevention of Respiratory Deterioration in Hospitalized COVID-19 Patients
Public ClinicalTrials.gov record NCT04472728. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Adaptive Design, Phase 2-3, Randomized, Double-blind, Multicenter Study, Evaluating Safety, Efficacy, PK-PD of BIO101 in Prevention of Respiratory Deterioration in Hospitalized Patients With COVID-19 Pneumonia (Severe)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The COVA clinical study is a global multicentric, double-blind, placebo-controlled, group sequential and adaptive 2 parts phase 2-3 study targeting in participants 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).
Study identification
- NCT ID
- NCT04472728
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 238 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 45 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 25, 2020
- Primary completion
- Jun 5, 2022
- Completion
- Jun 5, 2022
- Last update posted
- Aug 11, 2026
2020 – 2022
United States locations
- U.S. sites
- 6
- U.S. states
- 6
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Abrazo Health | Phoenix | Arizona | 85015 | — |
| University of California, Irvine | Irvine | California | 92697 | — |
| Barnum Medical Research, Inc. 1029 Keyser Ave Suite H | Natchitoches | Louisiana | 71457 | — |
| Beaumont Health | Royal Oak | Michigan | 48073 | — |
| United Health Services Hospitals | Johnson City | New York | 13903 | — |
| WellSpan Health | York | Pennsylvania | 17403 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04472728, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 11, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04472728 live on ClinicalTrials.gov.