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

Phase 2

Terminated

Conditions: COVID-19

Interventions: Drug: Placebo intravenous
Drug: BI 767551 intravenous
Drug: BI 767551 inhaled
Drug: Placebo inhaled

Registration Number: NCT04822701

Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phase II, Arm 1: Placebo intravenous (i.v.) + placebo inhaled	Placebo intravenous	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.
Phase II, Arm 1: Placebo intravenous (i.v.) + placebo inhaled	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.
Phase II, Arm 2: BI 767551 10 milligrams (mg)/kilogram (kg) intravenous (i.v.) + placebo inhaled	BI 767551 intravenous	-
Phase II, Arm 2: BI 767551 10 milligrams (mg)/kilogram (kg) intravenous (i.v.) + placebo inhaled	Placebo inhaled	-
Phase II, Arm 3: BI 767551 40 mg/kg intravenous (i.v.) + placebo inhaled	BI 767551 intravenous	-
Phase II, Arm 3: BI 767551 40 mg/kg intravenous (i.v.) + placebo inhaled	Placebo inhaled	-
Phase II, Arm 4: Placebo intravenous (i.v.) + BI 767551 250 mg inhaled	BI 767551 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.
Phase II, Arm 4: Placebo intravenous (i.v.) + BI 767551 250 mg inhaled	Placebo intravenous	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.
Phase III, Arm 1: BI 767551 (medium or high dose infusion) or low dose inhalation	BI 767551 intravenous	-
Phase III, Arm 2: Placebo	Placebo intravenous	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (5): Ocean Blue Medical Research Center, Inc.
🇺🇸
Miami Springs, Florida, United States
Advanced Surgeons and Physicians Network
🇺🇸
Houston, Texas, United States
Pharmatex Research
🇺🇸
Amarillo, Texas, United States
Crossroads Clinical Research
🇺🇸
Victoria, Texas, United States
Hospital Universitario Infanta Leonor
🇪🇸
Madrid, Spain