drugset / Trial / NCT04331054

Protective Role of Inhaled Steroids for Covid-19 Infection

NCT04331054 ↗

Phase 3 Terminated 146 enrolled Assistance Publique - Hôpitaux de Paris
RandomizedParallel-groupOpen-labelTreatment

Summary

We hypothesize that inhaled steroid therapy and long acting beta 2 adrenergic agonist, widely prescribed in asthma patients, may also have a local protective effect against coronavirus infection, even in patients without asthma. The primary purpose is To compare time to clinical improvement in patients receiving standard of care associated to the combination budesonide/formoterol or standard of care only. Time (in days) to clinical improvement is defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever came first within 30 days.

Timeline

Start
2020-04-13
Primary completion
2021-05-28
Completion
2021-05-28

Outcome

Outcome not reported

Stopped (Enrollment): “Insufficient recruitment”

Drugs

EvaluationDrugModalityDoseRoute
Subject Budesonide Small molecule 200 ug Inhaled
Subject Formoterol Other / unclassified 6 ug Inhaled

Indications