A Study to Test BI 767551 in People With Mild to Moderate Symptoms of COVID-19
Public ClinicalTrials.gov record NCT04822701. 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
A Phase II/III Seamless, Randomized, Double-blind, Placebo-controlled, Parallel-group, Group-sequential Study to Evaluate Efficacy, Safety and Tolerability of BI 767551 for the Treatment of Symptomatic, Non-hospitalized Adults With Mild to Moderate COVID-19.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is open to adults with mild to moderate symptoms of COVID-19 (coronavirus disease). The purpose of this study is to find out whether a medicine called BI 767551 helps people with COVID-19. BI 767551 is an antibody against the coronavirus. The study has 2 parts. Part 1 wants to find out the best dose of BI 767551 given as infusion into a vein. It also tests how BI 767551 is taken up by the body when taken via an inhaler. Participants are put into 4 groups by chance. Participants get BI 767551 or placebo once. * 1 group gets a high dose of BI 767551 as an infusion into a vein * 1 group gets a low dose of BI 767551 as an infusion into a vein * 1 group gets BI 767551 via an inhaler * 1 group gets placebo both as an infusion into a vein and via an inhaler The placebo infusion and inhaler look like the BI 767551 infusion and inhaler but do not contain any medicine. Doctors check how BI 767551 reduces the amount of coronavirus. Once the best dose of BI 767551 is found, part 2 of the study tests BI 767551 in a larger group of people. Also, in part 2, the participants get BI 767551 or placebo as an infusion into a vein once. In this part, doctors will check how many people need to be treated in a hospital or die. The results will be compared between the groups. For each part, participants are in the study for about 13 weeks. During this time, they visit the study site about 8 times and get about 3 remote visits. The doctors also regularly check participants' health and take note of any unwanted effects of BI 767551.
Study identification
- NCT ID
- NCT04822701
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 5 participants
Conditions and interventions
Conditions
Interventions
- BI 767551 intravenous Drug
- BI 767551 inhaled Drug
- Placebo intravenous Drug
- Placebo inhaled Drug
Drug
Eligibility (public fields only)
- Age range
- 18 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
- Apr 20, 2021
- Primary completion
- Jul 1, 2021
- Completion
- Oct 3, 2021
- Last update posted
- Jul 27, 2022
2021
United States locations
- U.S. sites
- 4
- U.S. states
- 2
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ocean Blue Medical Research Center, Inc. | Miami Springs | Florida | 33166 | — |
| Pharmatex Research | Amarillo | Texas | 79109 | — |
| Advanced Surgeons and Physicians Network | Houston | Texas | 77027 | — |
| Crossroads Clinical Research | Victoria | Texas | 77904 | — |
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 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04822701, 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 Jul 27, 2022 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04822701 live on ClinicalTrials.gov.