A Phase 2/3 interventional study of BI 767551 intravenous and BI 767551 inhaled in COVID-19, sponsored by Boehringer Ingelheim. Terminated at 5 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-28.
Sponsored by Boehringer Ingelheim · Phase 2/3, Interventional, and Treatment
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.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 5 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria phase II and III:
Exclusion criteria phase II and III:
Severe or critical COVID-19 including at least one of
Exclusion criterion phase III only:
Single dose of sterile normal saline (NaCl 0.9%) used as placebo for intravenous (i.v.) was administered as intravenous infusion over a period of 60 minutes plus a single inhaled of solvent for dilution of BI 767551 used as placebo for inhalation administered via inhalation through a mouthpiece (Aerogen® Ultra) using a mesh nebulizer (Aerogen® Solo) on Day 1, followed by a 90-day follow-up period. The inhalation procedure was to start approximately 25 min after the start of infusion.
Drug: Placebo intravenous · Drug: Placebo inhaled
Drug: BI 767551 intravenous · Drug: Placebo inhaled
Drug: BI 767551 intravenous · Drug: Placebo inhaled
Single dose of sterile normal saline (NaCl 0.9%) used as placebo for intravenous (i.v.) was administered as intravenous infusion over a period of 60 minutes plus a single inhaled of 250 milligrams (mg) of BI 767551 administered via inhalation through a mouthpiece (Aerogen® Ultra) using a mesh nebulizer (Aerogen® Solo) on Day 1, followed by a 90-day follow-up period. The inhalation procedure was to start approximately 25 min after the start of infusion.
Drug: BI 767551 inhaled · Drug: Placebo intravenous
Drug: BI 767551 intravenous
Drug: Placebo intravenous
BI 767551 intravenous
BI 767551 inhaled
Placebo intravenous
Placebo inhaled
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)
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.
Time frame: Up to 8 days
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)
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.
Time frame: Up to 29 days
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 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.
Time frame: At Day 4, Day 8, Day 15, Day 22, and Day 29
This study was planned to evaluate the concept of pharmacological activity of BI 767551 in non-hospitalised patients with mild to moderate COVID-19 symptoms. The study was terminated early. 5 patients total participated in phase II and phase III was not conducted.
| Milestone | Placebo Intravenous (i.v.) + Placebo Inhaled | Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled |
|---|---|---|
| Started | 4 | 1 |
| Treated | 2 | 1 |
| Completed | 0 | 1 |
| Not completed | 4 | 0 |
| Withdrew: Not treated | 2 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
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.
| log10 copies / milliliter | Placebo Intravenous (i.v.) + Placebo Inhaled | Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled |
|---|---|---|
| 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) | 0.15 ± 1.25 | -2.84 ± NA |
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.
| Participants | Placebo Intravenous (i.v.) + Placebo Inhaled | Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled |
|---|---|---|
| Day 4 — Yes | 0 | 0 |
| Day 4 — No | 2 | 1 |
| Day 4 — Missing | 0 | 0 |
| Day 8 — Yes | 0 | 0 |
| Day 8 — No | 2 | 1 |
| Day 8 — Missing | 0 | 0 |
| Day 15 — Yes | 1 | 1 |
| Day 15 — No | 1 | 0 |
| Day 15 — Missing | 0 | 0 |
| Day 22 — Yes | 1 | 0 |
| Day 22 — No | 0 | 0 |
| Day 22 — Missing | 1 | 1 |
| Day 29 — Yes | 0 | 0 |
| Day 29 — No | 0 | 0 |
| Day 29 — Missing | 2 | 1 |
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.
| log10 copies / milliliter | Placebo Intravenous (i.v.) + Placebo Inhaled | Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled |
|---|---|---|
| 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) | -2.09 ± 1.60 | -4.18 ± NA |
Collected over From dosing until end of 90-day follow-up period, up to 91 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo Intravenous (i.v.) + Placebo Inhaled | 0/2 (0%) | 0/2 (0%) | 2/2 (100%) |
| Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Event | Placebo Intravenous (i.v.) + Placebo Inhaled | Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled |
|---|---|---|
| DizzinessNervous system disorders | 1/2 | 1/1 |
| ParotitisInfections and infestations | 1/2 | 0/1 |
| Alanine aminotransferase increasedInvestigations | 1/2 | 0/1 |
| Aspartate aminotransferase increasedInvestigations | 1/2 | 0/1 |
| Gamma-glutamyltransferase increasedInvestigations | 1/2 | 0/1 |
| Back painMusculoskeletal and connective tissue disorders | 1/2 | 0/1 |
Treated set (TS): This subject set includes all subjects who received any amount of study drug.
| Age, Continuous(Years) | Placebo Intravenous (i.v.) + Placebo Inhaled | Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled | Total |
|---|---|---|---|
| Mean | 35.5 ± 10.6 | 37.0 ± NA | 36.0 ± 7.5 |
| Sex: Female, Male(Participants) | Placebo Intravenous (i.v.) + Placebo Inhaled | Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled | Total |
|---|---|---|---|
| Female | 2 | 1 | 3 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Placebo Intravenous (i.v.) + Placebo Inhaled | Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 0 | 2 |
| Not Hispanic or Latino | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo Intravenous (i.v.) + Placebo Inhaled | Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 2 | 1 | 3 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Log-transformed Nasopharyngeal (NP) swab viral load at baseline(log10 copies / milliliter) | Placebo Intravenous (i.v.) + Placebo Inhaled | Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled | Total |
|---|---|---|---|
| Mean | 5.24 ± 2.09 | 7.32 ± NA | 5.93 ± 1.90 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.
Supporting information: Study protocol, Sap, Csr
This study is terminated, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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