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NCT04822701 · ClinicalTrials.gov registry record · Phase 2
A Study to Test BI 767551 in People With Mild to Moderate Symptoms of COVID-19
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT04822701: Clinical Trial Phase 2 study, sponsored by Boehringer Ingelheim.
NCT04822701 is a Phase 2 study that was terminated before completion, run by Boehringer Ingelheim. The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04822701, a Phase 2 study, was terminated before completion, sponsored by Boehringer Ingelheim.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Time-weighted change from baseline in viral shedding over 8 days in site collected nasopharyngeal (NP) swabs by Quantitative Reverse Transcription Polymerase chain reaction (RT-qPCR), defined as a absolute change from baseline in log10 viral load, is reported.
Interventions
- DRUG BI 767551 intravenous
- DRUG BI 767551 inhaled
- DRUG Placebo intravenous
- DRUG Placebo inhaled
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2021-04-21 |
| Est. Completion | 2021-10-04 |
| Phase | Phase 2 |
Why NCT04822701 stopped before completion
NCT04822701 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 4 interventions - of which BI 767551 intravenous is the first listed.
NCT04822701 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04822701 about?
NCT04822701 is a clinical study titled "A Study to Test BI 767551 in People With Mild to Moderate Symptoms of COVID-19". 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 ...
What is the current status of trial NCT04822701?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2021-04-21. Estimated completion is 2021-10-04.
What interventions are being tested in trial NCT04822701?
The interventions under investigation include: BI 767551 intravenous (DRUG), BI 767551 inhaled (DRUG), Placebo intravenous (DRUG), Placebo inhaled (DRUG).
Who is sponsoring clinical trial NCT04822701?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04822701's enrollment target sits among peer trials
5 2000th of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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