A Study to Test BI 767551 in People With Mild to Moderate Symptoms of COVID-19
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2/Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Placebo Comparator: Phase II, Arm 1: Placebo intravenous (i.v.) + 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 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
Placebo intravenous
Drug: Placebo inhaled
Placebo inhaled
|
Experimental: Phase II, Arm 2: BI 767551 10 milligrams (mg)/kilogram (kg) intravenous (i.v.) + placebo inhaled
|
Drug: BI 767551 intravenous
BI 767551 intravenous
Drug: Placebo inhaled
Placebo inhaled
|
Experimental: Phase II, Arm 3: BI 767551 40 mg/kg intravenous (i.v.) + placebo inhaled
|
Drug: BI 767551 intravenous
BI 767551 intravenous
Drug: Placebo inhaled
Placebo inhaled
|
Experimental: Phase II, Arm 4: Placebo intravenous (i.v.) + BI 767551 250 mg 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
BI 767551 inhaled
Drug: Placebo intravenous
Placebo intravenous
|
Experimental: Phase III, Arm 1: BI 767551 (medium or high dose infusion) or low dose inhalation
|
Drug: BI 767551 intravenous
BI 767551 intravenous
|
Placebo Comparator: Phase III, Arm 2: Placebo
|
Drug: Placebo intravenous
Placebo intravenous
|
Outcome Measures
Primary Outcome Measures
- 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) [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.
- 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) [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.
Secondary Outcome Measures
- 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 [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.
Eligibility Criteria
Criteria
Inclusion criteria phase II and III:
-
≥ 18 years old, males and females
-
Signed and dated written informed consent in accordance with International Council on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
-
Documentation of laboratory-confirmed Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, as determined by a molecular test (antigen or nucleic acid) from any respiratory tract specimen (nasopharyngeal (NP) or nasal swab or saliva) collected no more than 72 hours prior to start of treatment
-
Patients experienced mild to moderate Coronavirus Disease 2019 (COVID-19)-related symptoms or measured fever for no more than 5 days prior to start of treatment where symptoms are defined by fever, feeling feverish, fatigue, cough, shortness of breath at rest or during activity, sore throat, body pain or muscle pain/ aches, chills, headache, nasal obstruction or congestion, loss of smell or taste, nausea, diarrhea, vomiting, or dysgeusia
-
One or more of the following signs/symptoms present on day of start of treatment: fever, feeling feverish, fatigue, cough, shortness of breath at rest or during activity, sore throat, body pain or muscle pain/ aches, chills, headache, nasal obstruction or congestion, loss of smell or taste, nausea, diarrhea, vomiting, or dysgeusia
-
Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly
Exclusion criteria phase II and III:
-
Body weight of less than 40 kg
-
Severe or critical COVID-19 including at least one of
-
Oxygen saturation (SpO2) ≤ 93 % on room air or on their usual level of oxygen supplementation in case of chronic oxygen use
-
Ratio of arterial oxygen partial pressure (PaO2 in millimeters of mercury) to fractional inspired oxygen (FiO2) < 300 (in case arterial blood sample was taken)
-
History of hospitalization for COVID-19
-
Current or imminent need for hospitalization or immediate medical attention in the clinical opinion of the site investigator. Does not include patients hospitalized for isolation only
-
Receipt of intravenous immunoglobulin within 12 weeks prior to Visit 2
-
Receipt of COVID-19 convalescent plasma treatment at any time prior to Visit 2
-
Receipt of any SARS-CoV-2 monoclonal antibody treatment at any time prior to Visit 2
-
Receipt of SARS-CoV-2 vaccine at any time prior to Visit 2
-
Receipt of an investigational product for COVID-19 within 5 half-lives prior to Visit 2
-
Receipt of systemic steroids (e.g. prednisone, dexamethasone) within 4 weeks prior to Visit 2 unless used for chronic condition Further exclusion criteria apply.
Exclusion criterion phase III only:
- Previous enrolment in this trial. Patients participating in Phase II are not eligible for Phase III. Re-screening is allowed once, for repeat of Quantitative Reverse Transcription Polymerase chain reaction (RT-qPCR) or antigen SARS-CoV-2 test, if required. The test method used for initial screening (RT-qPCR or antigen) should be used for re-screening.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Ocean Blue Medical Research Center, Inc. | Miami Springs | Florida | United States | 33166 |
2 | Pharmatex Research | Amarillo | Texas | United States | 79109 |
3 | Advanced Surgeons and Physicians Network | Houston | Texas | United States | 77027 |
4 | Crossroads Clinical Research | Victoria | Texas | United States | 77904 |
5 | Hospital Universitario Infanta Leonor | Madrid | Spain | 28031 |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
None specified.Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- 1487-0001
- 2020-005588-29
Study Results
Participant Flow
Recruitment Details | 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. |
---|---|
Pre-assignment Detail | All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated. |
Arm/Group Title | Placebo Intravenous (i.v.) + Placebo Inhaled | Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled |
---|---|---|
Arm/Group Description | Single dose of sterile normal saline (NaCl 0.9%) used as placebo was administered as intravenous (i.v.) 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. | Single dose of sterile normal saline (NaCl 0.9%) used as placebo was administered as intravenous (i.v.) 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. |
Period Title: Overall Study | ||
STARTED | 4 | 1 |
Treated | 2 | 1 |
COMPLETED | 0 | 1 |
NOT COMPLETED | 4 | 0 |
Baseline Characteristics
Arm/Group Title | Placebo Intravenous (i.v.) + Placebo Inhaled | Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled | Total |
---|---|---|---|
Arm/Group Description | Single dose of sterile normal saline (NaCl 0.9%) used as placebo was administered as intravenous (i.v.) 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. | Single dose of sterile normal saline (NaCl 0.9%) used as placebo was administered as intravenous (i.v.) 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. | Total of all reporting groups |
Overall Participants | 2 | 1 | 3 |
Age (Years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [Years] |
35.5
(10.6)
|
37.0
(NA)
|
36.0
(7.5)
|
Sex: Female, Male (Count of Participants) | |||
Female |
2
100%
|
1
100%
|
3
100%
|
Male |
0
0%
|
0
0%
|
0
0%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
2
100%
|
0
0%
|
2
66.7%
|
Not Hispanic or Latino |
0
0%
|
1
100%
|
1
33.3%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
Asian |
0
0%
|
0
0%
|
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
Black or African American |
0
0%
|
0
0%
|
0
0%
|
White |
2
100%
|
1
100%
|
3
100%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Log-transformed Nasopharyngeal (NP) swab viral load at baseline (log10 copies / milliliter) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [log10 copies / milliliter] |
5.24
(2.09)
|
7.32
(NA)
|
5.93
(1.90)
|
Outcome Measures
Title | 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) |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Modified Intention-To-Treat set (mITT): This subject set includes all randomised subjects that received any amount of study drug and who have at least a measurable baseline value (above Lower limit of quantification (LLOQ)) and a second measurement in the first week (up to 7 days after drug intake) of SARS-CoV-2 RNA by site collected nasopharyngeal (NP) swab. |
Arm/Group Title | Placebo Intravenous (i.v.) + Placebo Inhaled | Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled |
---|---|---|
Arm/Group Description | Single dose of sterile normal saline (NaCl 0.9%) used as placebo was administered as intravenous (i.v.) 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. | Single dose of sterile normal saline (NaCl 0.9%) used as placebo was administered as intravenous (i.v.) 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. |
Measure Participants | 2 | 1 |
Mean (Standard Deviation) [log10 copies / milliliter] |
0.15
(1.25)
|
-2.84
(NA)
|
Title | 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 |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Treated set (TS): This subject set includes all subjects who received any amount of study drug. |
Arm/Group Title | Placebo Intravenous (i.v.) + Placebo Inhaled | Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled |
---|---|---|
Arm/Group Description | Single dose of sterile normal saline (NaCl 0.9%) used as placebo was administered as intravenous (i.v.) 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. | Single dose of sterile normal saline (NaCl 0.9%) used as placebo was administered as intravenous (i.v.) 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. |
Measure Participants | 2 | 1 |
Yes |
0
0%
|
0
0%
|
No |
2
100%
|
1
100%
|
Missing |
0
0%
|
0
0%
|
Yes |
0
0%
|
0
0%
|
No |
2
100%
|
1
100%
|
Missing |
0
0%
|
0
0%
|
Yes |
1
50%
|
1
100%
|
No |
1
50%
|
0
0%
|
Missing |
0
0%
|
0
0%
|
Yes |
1
50%
|
0
0%
|
No |
0
0%
|
0
0%
|
Missing |
1
50%
|
1
100%
|
Yes |
0
0%
|
0
0%
|
No |
0
0%
|
0
0%
|
Missing |
2
100%
|
1
100%
|
Title | 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) |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Modified Intention-To-Treat set (mITT): This subject set includes all randomised subjects that received any amount of study drug and who have at least a measurable baseline value (above Lower limit of quantification (LLOQ)) and a second measurement in the first week (up to 7 days after drug intake) of SARS-CoV-2 RNA by site collected nasopharyngeal (NP) swab. |
Arm/Group Title | Placebo Intravenous (i.v.) + Placebo Inhaled | Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled |
---|---|---|
Arm/Group Description | Single dose of sterile normal saline (NaCl 0.9%) used as placebo was administered as intravenous (i.v.) 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. | Single dose of sterile normal saline (NaCl 0.9%) used as placebo was administered as intravenous (i.v.) 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. |
Measure Participants | 2 | 1 |
Mean (Standard Deviation) [log10 copies / milliliter] |
-2.09
(1.60)
|
-4.18
(NA)
|
Adverse Events
Time Frame | From dosing until end of 90-day follow-up period, up to 91 days. | |||
---|---|---|---|---|
Adverse Event Reporting Description | Treated set (TS): This subject set includes all subjects who received any amount of study drug. | |||
Arm/Group Title | Placebo Intravenous (i.v.) + Placebo Inhaled | Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled | ||
Arm/Group Description | Single dose of sterile normal saline (NaCl 0.9%) used as placebo was administered as intravenous (i.v.) 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. | Single dose of sterile normal saline (NaCl 0.9%) used as placebo was administered as intravenous (i.v.) 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. | ||
All Cause Mortality |
||||
Placebo Intravenous (i.v.) + Placebo Inhaled | Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/2 (0%) | 0/1 (0%) | ||
Serious Adverse Events |
||||
Placebo Intravenous (i.v.) + Placebo Inhaled | Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/2 (0%) | 0/1 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Placebo Intravenous (i.v.) + Placebo Inhaled | Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 2/2 (100%) | 1/1 (100%) | ||
Infections and infestations | ||||
Parotitis | 1/2 (50%) | 0/1 (0%) | ||
Investigations | ||||
Alanine aminotransferase increased | 1/2 (50%) | 0/1 (0%) | ||
Aspartate aminotransferase increased | 1/2 (50%) | 0/1 (0%) | ||
Gamma-glutamyltransferase increased | 1/2 (50%) | 0/1 (0%) | ||
Musculoskeletal and connective tissue disorders | ||||
Back pain | 1/2 (50%) | 0/1 (0%) | ||
Nervous system disorders | ||||
Dizziness | 1/2 (50%) | 1/1 (100%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Results Point of Contact
Name/Title | Boehringer Ingelheim Call Center |
---|---|
Organization | Boehringer Ingelheim |
Phone | 1-800-243-0127 |
clintriage.rdg@boehringer-ingelheim.com |
- 1487-0001
- 2020-005588-29