18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Phase II: 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)Primary· Up to 8 days
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.
Group
Value
95% CI
Placebo Intravenous (i.v.) + Placebo Inhaled
0.15
± 1.25
Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled
-2.84
± NA
Phase II: Number of Participants With Loss of Detection of Severe Acute Respiratory Syndrome Coronavirus 2 Ribonucleic Acid (SARS-CoV-2 RNA) by Site Collected NP Swab at Day 4, 8, 15, 22 and 29Secondary· At Day 4, Day 8, Day 15, Day 22, and Day 29
Number of participants with loss of detection of Severe acute respiratory syndrome coronavirus 2 ribonucleic acid (SARS-CoV-2 RNA) by site collected NP swab at Day 4, 8, 15, 22 and 29 is report. The "Yes" = loss of detection of SARS-CoV-2 RNA; "No" = SARS-CoV-2 RNA detected; "Missing" = not evaluable.
Day 4
Group
Value
95% CI
Placebo Intravenous (i.v.) + Placebo Inhaled
0
Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled
0
Placebo Intravenous (i.v.) + Placebo Inhaled
2
Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled
1
Placebo Intravenous (i.v.) + Placebo Inhaled
0
Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled
0
Day 8
Group
Value
95% CI
Placebo Intravenous (i.v.) + Placebo Inhaled
0
Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled
0
Placebo Intravenous (i.v.) + Placebo Inhaled
2
Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled
1
Placebo Intravenous (i.v.) + Placebo Inhaled
0
Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled
0
Day 15
Group
Value
95% CI
Placebo Intravenous (i.v.) + Placebo Inhaled
1
Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled
1
Placebo Intravenous (i.v.) + Placebo Inhaled
1
Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled
0
Placebo Intravenous (i.v.) + Placebo Inhaled
0
Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled
0
Day 22
Group
Value
95% CI
Placebo Intravenous (i.v.) + Placebo Inhaled
1
Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled
0
Placebo Intravenous (i.v.) + Placebo Inhaled
0
Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled
0
Placebo Intravenous (i.v.) + Placebo Inhaled
1
Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled
1
Day 29
Group
Value
95% CI
Placebo Intravenous (i.v.) + Placebo Inhaled
0
Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled
0
Placebo Intravenous (i.v.) + Placebo Inhaled
0
Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled
0
Placebo Intravenous (i.v.) + Placebo Inhaled
2
Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled
1
Phase II: Time-weighted Change From Baseline in Viral Shedding Over 29 Days in Site Collected Nasopharyngeal (NP) Swabs by Quantitative Reverse Transcription Polymerase Chain Reaction (RT-qPCR)Primary· Up to 29 days
Time-weighted change from baseline in viral shedding over 29 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.
Group
Value
95% CI
Placebo Intravenous (i.v.) + Placebo Inhaled
-2.09
± 1.60
Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled
-4.18
± NA
Adverse events — posted to ClinicalTrials.gov
Time frame: From dosing until end of 90-day follow-up period, up to 91 days..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Placebo Intravenous (i.v.) + Placebo Inhaled
Serious: 0/2 (0%)
Deaths: 0/2
Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04894474 — A Study to Test Whether BI 767551 Can Prevent COVID-19 in People Who Have Been Exposed to SARS-CoV-2
· Phase 2, PHASE3
· withdrawn
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Other Boehringer Ingelheim trials
Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 28 July 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04822701.