drugset / Trial / NCT04640194

A Study to Test Whether Different Doses of Alteplase Help People With Severe Breathing Problems Because of COVID-19

NCT04640194

Phase 2/3 Completed 104 enrolled Boehringer Ingelheim
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a study in adults with severe breathing problems because of COVID-19. People who are in hospital on breathing support can participate in the study. The purpose of the study is to find out whether a medicine called alteplase helps people get better faster. The study has 2 parts. In the first part, participants are put into 3 groups by chance. Participants in 2 of the groups get 2 different doses of alteplase, in addition to standard treatment. Participants in the third group get standard treatment. In the second part of the study, participants are put into 2 groups by chance. One group gets alteplase and standard treatment. The other group gets only standard treatment. Alteplase is given as an infusion into a vein. In both study parts, treatments are given for 5 days. Doctors monitor patients and check whether their breathing problems improve. They compare results between the groups after 1 month. Participants are in the study for 3 months.

Timeline

Start
2020-12-16
Primary completion
2022-07-19
Completion
2022-07-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Alteplase Protein / enzyme biologic 0.02 mg/kg Intravenous
Subject Alteplase Protein / enzyme biologic 0.04 mg/kg Intravenous