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.
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 department by the
pneumologist investigator.
Patients will be randomized either to the control group or to the intervention group. For
interventional patients, trial treatment (SYMBICORT RAPIHALER 200/6 µ) will begin within 12
hours.
Follow-up period (D2 to D29) and end of study visit (D30):
Throughout their hospital stay, patients will be followed in accordance with the practice of
the service.
During hospitalization, investigators are free to decide for antibiotics, steroids, anti
viral drugs, hydroxychloroquine and oxygen support management in accordance with local
practice. None of the laboratory tests are made for the study. They are usually performed in
patients hospitalized for acute respiratory infection.
Interventional patient will also be treated with SYMBICORT RAPIHALER 200/6 µg (2 puffs 2
times a day).
In the event that the patient is discharged from hospital before the end of his
participation, he will be contacted by phone on D30 in order to obtain information concerning
the period outside hospitalization
Drug: 2: Usual practice + SYMBICORT RAPIHALER
2 puffs bid during 30 days by inhalation
Other: 1: Usual practice
Usual practice
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
Hôpital Bichat - Service de Pneumologie
Paris, France
Camille TAILLE, MD, PhD, Principal Investigator
Assistance Publique - Hôpitaux de Paris