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

  • STATUS
    Not Recruiting
  • End date
    Aug 15, 2023
  • participants needed
    320
  • sponsor
    Boehringer Ingelheim
Updated on 8 August 2022
ct scan
mechanical ventilation
chest x-ray
intubation
fluid overload
x-rays
d-dimer
acute respiratory distress
FIO2
respiratory failure
pao2
covid-19
pao2/fio2 ratio
SARS
oximetry
effusions
assisted breathing
assisted ventilation

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.

Details
Condition Acute Respiratory Distress Syndrome
Treatment Standard of Care, Alteplase
Clinical Study IdentifierNCT04640194
SponsorBoehringer Ingelheim
Last Modified on8 August 2022

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