Status:
TERMINATED
Protective Role of Inhaled Steroids for Covid-19 Infection
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Covid-19 Infection
Hospitalization in Respiratory Disease Department
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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...
Detailed Description
D1 inclusion / randomization visit: Patients who meet the eligibility criteria and whose infection with Covid-19 has been confirmed within 48 hours will be included in the respiratory diseases depart...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2021
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT04331054
Start Date
April 13 2020
End Date
May 28 2021
Last Update
August 3 2021
Active Locations (1)
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1
Hôpital Bichat - Service de Pneumologie
Paris, France, 75010