Trial Outcomes & Findings for A Study to Test BI 767551 in People With Mild to Moderate Symptoms of COVID-19 (NCT NCT04822701)
NCT ID: NCT04822701
Last Updated: 2022-07-28
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
5 participants
Primary outcome timeframe
Up to 8 days
Results posted on
2022-07-28
Participant Flow
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.
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.
Participant milestones
| Measure |
Placebo Intravenous (i.v.) + Placebo Inhaled
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.
|
Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled
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.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
1
|
|
Overall Study
Treated
|
2
|
1
|
|
Overall Study
COMPLETED
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
Placebo Intravenous (i.v.) + Placebo Inhaled
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.
|
Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled
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.
|
|---|---|---|
|
Overall Study
Not treated
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
A Study to Test BI 767551 in People With Mild to Moderate Symptoms of COVID-19
Baseline characteristics by cohort
| Measure |
Placebo Intravenous (i.v.) + Placebo Inhaled
n=2 Participants
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.
|
Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled
n=1 Participants
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
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.5 Years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
37.0 Years
STANDARD_DEVIATION NA • n=7 Participants
|
36.0 Years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Log-transformed Nasopharyngeal (NP) swab viral load at baseline
|
5.24 log10 copies / milliliter
STANDARD_DEVIATION 2.09 • n=5 Participants
|
7.32 log10 copies / milliliter
STANDARD_DEVIATION NA • n=7 Participants
|
5.93 log10 copies / milliliter
STANDARD_DEVIATION 1.90 • n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 8 daysPopulation: 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.
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.
Outcome measures
| Measure |
Placebo Intravenous (i.v.) + Placebo Inhaled
n=2 Participants
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.
|
Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled
n=1 Participants
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.
|
|---|---|---|
|
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 log10 copies / milliliter
Standard Deviation 1.25
|
-2.84 log10 copies / milliliter
Standard Deviation NA
Only 1 participant was analyzed and no standard deviation can be calculated.
|
PRIMARY outcome
Timeframe: Up to 29 daysPopulation: 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.
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.
Outcome measures
| Measure |
Placebo Intravenous (i.v.) + Placebo Inhaled
n=2 Participants
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.
|
Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled
n=1 Participants
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.
|
|---|---|---|
|
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 log10 copies / milliliter
Standard Deviation 1.60
|
-4.18 log10 copies / milliliter
Standard Deviation NA
Only 1 participant was analyzed and no standard deviation can be calculated.
|
SECONDARY outcome
Timeframe: At Day 4, Day 8, Day 15, Day 22, and Day 29Population: Treated set (TS): This subject set includes all subjects who received any amount of study drug.
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.
Outcome measures
| Measure |
Placebo Intravenous (i.v.) + Placebo Inhaled
n=2 Participants
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.
|
Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled
n=1 Participants
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.
|
|---|---|---|
|
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
Day 4 · Yes
|
0 Participants
|
0 Participants
|
|
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
Day 4 · No
|
2 Participants
|
1 Participants
|
|
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
Day 4 · Missing
|
0 Participants
|
0 Participants
|
|
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
Day 8 · Yes
|
0 Participants
|
0 Participants
|
|
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
Day 8 · No
|
2 Participants
|
1 Participants
|
|
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
Day 8 · Missing
|
0 Participants
|
0 Participants
|
|
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
Day 15 · Yes
|
1 Participants
|
1 Participants
|
|
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
Day 15 · No
|
1 Participants
|
0 Participants
|
|
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
Day 15 · Missing
|
0 Participants
|
0 Participants
|
|
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
Day 22 · Yes
|
1 Participants
|
0 Participants
|
|
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
Day 22 · No
|
0 Participants
|
0 Participants
|
|
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
Day 22 · Missing
|
1 Participants
|
1 Participants
|
|
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
Day 29 · Yes
|
0 Participants
|
0 Participants
|
|
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
Day 29 · No
|
0 Participants
|
0 Participants
|
|
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
Day 29 · Missing
|
2 Participants
|
1 Participants
|
Adverse Events
Placebo Intravenous (i.v.) + Placebo Inhaled
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Intravenous (i.v.) + Placebo Inhaled
n=2 participants at risk
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.
|
Placebo Intravenous (i.v.) + BI 767551 250 mg Inhaled
n=1 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Parotitis
|
50.0%
1/2 • From dosing until end of 90-day follow-up period, up to 91 days.
Treated set (TS): This subject set includes all subjects who received any amount of study drug.
|
0.00%
0/1 • From dosing until end of 90-day follow-up period, up to 91 days.
Treated set (TS): This subject set includes all subjects who received any amount of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
1/2 • From dosing until end of 90-day follow-up period, up to 91 days.
Treated set (TS): This subject set includes all subjects who received any amount of study drug.
|
0.00%
0/1 • From dosing until end of 90-day follow-up period, up to 91 days.
Treated set (TS): This subject set includes all subjects who received any amount of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
1/2 • From dosing until end of 90-day follow-up period, up to 91 days.
Treated set (TS): This subject set includes all subjects who received any amount of study drug.
|
0.00%
0/1 • From dosing until end of 90-day follow-up period, up to 91 days.
Treated set (TS): This subject set includes all subjects who received any amount of study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
50.0%
1/2 • From dosing until end of 90-day follow-up period, up to 91 days.
Treated set (TS): This subject set includes all subjects who received any amount of study drug.
|
0.00%
0/1 • From dosing until end of 90-day follow-up period, up to 91 days.
Treated set (TS): This subject set includes all subjects who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
50.0%
1/2 • From dosing until end of 90-day follow-up period, up to 91 days.
Treated set (TS): This subject set includes all subjects who received any amount of study drug.
|
0.00%
0/1 • From dosing until end of 90-day follow-up period, up to 91 days.
Treated set (TS): This subject set includes all subjects who received any amount of study drug.
|
|
Nervous system disorders
Dizziness
|
50.0%
1/2 • From dosing until end of 90-day follow-up period, up to 91 days.
Treated set (TS): This subject set includes all subjects who received any amount of study drug.
|
100.0%
1/1 • From dosing until end of 90-day follow-up period, up to 91 days.
Treated set (TS): This subject set includes all subjects who received any amount of study drug.
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER