A Study to Test BI 767551 in People With Mild to Moderate Symptoms of COVID-19

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Terminated
CT.gov ID
NCT04822701
Collaborator
(none)
5
5
6
5.5
1
0.2

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
  • Drug: BI 767551 intravenous
  • Drug: BI 767551 inhaled
  • Drug: Placebo intravenous
  • Drug: Placebo inhaled
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
5 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This trial consists of two phases: Exploratory Phase II: Randomised, double-blind, placebo controlled, doubledummy,Phase II, parallel group design comparing different doses and modes of administration of BI 767551 to placebo. Confirmatory Phase III: Randomised, double-blind, placebo-controlled, parallel group, Phase III comparing BI 767551 to placebo.This trial consists of two phases:Exploratory Phase II:Randomised, double-blind, placebo controlled, doubledummy,Phase II, parallel group design comparing different doses and modes of administration of BI 767551 to placebo.Confirmatory Phase III:Randomised, double-blind, placebo-controlled, parallel group, Phase III comparing BI 767551 to placebo.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase II/III Seamless, Randomized, Double-blind, Placebo-controlled, Parallel-group, Group-sequential Study to Evaluate Efficacy, Safety and Tolerability of BI 767551 for the Treatment of Symptomatic, Non-hospitalized Adults With Mild to Moderate COVID-19.
Actual Study Start Date :
Apr 21, 2021
Actual Primary Completion Date :
Jul 2, 2021
Actual Study Completion Date :
Oct 4, 2021

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

  1. 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.

  2. 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

  1. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT04822701
Other Study ID Numbers:
  • 1487-0001
  • 2020-005588-29
First Posted:
Mar 30, 2021
Last Update Posted:
Jul 28, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

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

1. Primary Outcome
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)
2. Secondary Outcome
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%
3. Primary Outcome
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

This trial was prematurely discontinued due to sponsor decision. 4 participants were enrolled in the Phase II "Placebo intravenous (i.v.) + placebo inhaled" group and 1 participant in the "Placebo intravenous (i.v.) + BI 250 mg inhaled" group. No patients were entered in the planned Phase II "BI 10 milligrams (mg)/kilogram (kg) intravenous (i.v.) + placebo inhaled" and "BI 40 mg/kg i.v. + placebo inhaled" groups. Phase III part was not conducted.

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
Email clintriage.rdg@boehringer-ingelheim.com
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT04822701
Other Study ID Numbers:
  • 1487-0001
  • 2020-005588-29
First Posted:
Mar 30, 2021
Last Update Posted:
Jul 28, 2022
Last Verified:
Jul 1, 2022