Clinical trial NCT04331054: Protective Role of Inhaled Steroids for Covid-19 Infection
Official title: Protective Role of Inhaled Steroids for Covid-19 Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Covid-19 Infection
Hospitalization in Respiratory Disease Department
Keywords: Covid-19
Asthma
Inhaled steroids
Formoterol
Oxygen
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-04-02
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 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

Eligibility 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

Primary outcomes:
measure: Time (in days) to clinical improvement within 30 days after randomization
timeFrame: within 30 days
Secondary outcomes:
measure: Mortality rate at D30
timeFrame: At day30
measure: Time (in days) from randomization to death
timeFrame: up to 30 days after randomization
measure: Number of days alive outside ICU within 30 days
timeFrame: At day30
measure: Number of days alive free of invasive or non-invasive ventilation within 30 days
timeFrame: At day30
measure: Number of days alive with oxygen therapy within 30 days
timeFrame: At day30
measure: Maximal oxygen rate within 30 days
timeFrame: At day30
measure: Difference between PaO2/FiO2 ratio at randomization and at Day 7 (or at the time of stopping oxygen therapy or discharge if occurs before Day 7)
timeFrame: at Day 7
measure: Number of days alive outside hospital within 30 days
timeFrame: at Day 30
measure: Use of antibiotics for respiratory (proved or suspected) infection within 30 days
timeFrame: at Day 30
measure: Difference between CRP levels at randomization and at Day 7 (or at the time of discharge if occurs before Day 7)
timeFrame: at Day 7
measure: Safety outcomes included events that occurred during treatment, serious adverse events, and premature discontinuation of treatment.
timeFrame: up to 30 days after randomization
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Bichat - Service de Pneumologie
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Camille TAILLE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: