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

NCT04822701 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2022-07-28

Study results available
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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.

Conditions

Interventions

DRUG

BI 767551 intravenous

BI 767551 intravenous

DRUG

BI 767551 inhaled

BI 767551 inhaled

DRUG

Placebo intravenous

Placebo intravenous

DRUG

Placebo inhaled

Placebo inhaled

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-21
Primary Completion
2021-07-02
Completion
2021-10-04
FDA Drug
Yes

Countries

  • United States
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04822701 on ClinicalTrials.gov