Protective Role of Inhaled Steroids for Covid-19 Infection

• Status: Terminated
• Trial end date: 2021-05-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Budesonide, Formoterol Fumarate Drug Combination

Criteria

Inclusion criera :

• Patient ≥ 18 years old and ≤ 75 years old

• Laboratory proved infection by COVID-19 by RT-PCR on a respiratory biological sample within 2 days

• Hospitalization is required according to current local recommendations

• Patient affiliated to a social security regime

• Patient able to give free, informed and written consent

Exclusion criteria :

• Oxygen flow rate >8l/min at inclusion

• Current treatment with any inhaled steroid (any other form of steroid administration does not exclude the patient)

• Intensive care unit is required for the patient (based on investigator judgement)

• Patient with cognitive impairment which do not guarantee proper use of the treatment by the patient himself

• Pregnant (positive β-HCG at inclusion) or breastfeeding women

• Participation in another interventional drug study involving human participants and concerning COVID-19 infection or being in the exclusion period of a previous study involving human participants

• Contraindications to the treatments (history of hypersensitivity)

• Patient admitted for isolation, for social reason or due to comorbidities without gravity sign

• Long-term patient treated with digitalis, disopyramide, procainamide or phenothiazine that could lengthen the QT space