Protective Role of Inhaled Steroids for Covid-19 Infection
- Conditions
- Hospitalization in Respiratory Disease DepartmentCovid-19 Infection
- Registration Number
- NCT04331054
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 146
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Time (in days) to clinical improvement within 30 days after randomization within 30 days 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.
The seven-category ordinal scale consisted of the following categories:
1. Not hospitalized with resumption of normal activities
2. Not hospitalized, but unable to resume normal activities
3. Hospitalized, not requiring supplemental oxygen
4. Hospitalized, requiring supplemental oxygen
5. Hospitalized, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation, or both;
6. Hospitalized, requiring ECMO, invasive mechanical ventilation, or both
7. Death.
These parameters will be evaluated daily during hospitalization.
- Secondary Outcome Measures
Name Time Method Mortality rate at D30 At day30 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) at Day 7 Number of days alive outside hospital within 30 days at Day 30 Use of antibiotics for respiratory (proved or suspected) infection within 30 days at Day 30 Number of days alive outside ICU within 30 days At day30 Time (in days) from randomization to death up to 30 days after randomization Difference between CRP levels at randomization and at Day 7 (or at the time of discharge if occurs before Day 7) at Day 7 Safety outcomes included events that occurred during treatment, serious adverse events, and premature discontinuation of treatment. up to 30 days after randomization Number of days alive free of invasive or non-invasive ventilation within 30 days At day30 Number of days alive with oxygen therapy within 30 days At day30 Maximal oxygen rate within 30 days At day30
Trial Locations
- Locations (1)
Hôpital Bichat - Service de Pneumologie
🇫🇷Paris, France