NCT04604184

ACTION ON COVID-19: A Study to Test Whether BI 764198 Helps Lung Health of People Hospitalised With COVID-19

BI 764198 Efficacy and Safety in Prevention/Progression of ARDS and ARDS-related Complications Secondary to COVID-19 (ACTION ON COVID-19)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This study is open to adults with COVID-19 infection who are in hospital and receive oxygen. Participants need to be 50 years of age or older and need to be at risk of further worsening of their condition. The purpose of the study is to find out whether a medicine called BI 764198 helps people with COVID-19 infection and breathing problems. BI 764198 may prevent cell death and swelling of the lung tissue and therefore help patients with COVID-19 infection. Participants are put into 2 groups by chance. One group of participants gets BI 764198 capsules and the other group gets placebo capsules. The placebo capsules look exactly like the BI 764198 capsules but do not contain any medicine. Participants take 1 capsule per day. Participants are in the study for about a month. At study end, doctors compare the 2 groups for the number of patients that are alive and do not need mechanical breathing support. During the study, the doctors collect information on any health problems of the participants.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	BI 764198	BI 764198
DRUG	Placebo	Placebo

Timeline

• Start date: 2020-11-03
• Primary completion: 2021-03-24
• Completion: 2021-05-31
• First posted: 2020-10-27
• Last updated: 2022-04-11
• Results posted: 2022-04-11

Locations

25 sites across 6 countries: United States, Brazil, Chile, Mexico, Puerto Rico, Spain

Regulatory

• FDA-regulated drug study