Protective Role of Inhaled Steroids for Covid-19 Infection (INHASCO)

Assistance Publique - Hôpitaux de Paris

Status and phase

Terminated

Phase 3

Conditions

Covid-19 Infection

Hospitalization in Respiratory Disease Department

Treatments

Drug: 2: Usual practice + SYMBICORT RAPIHALER

Other: 1: Usual practice

Study type

Interventional

Funder types

Other

Identifiers

NCT04331054

P 200394

2020-001306-35 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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 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

Enrollment

146 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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