COVID-19
Conditions
Interventions
Trade Name: SYMBICORT RAPIHALER 200/6 µg par dose, suspension pour inhalation en flacon pressurisé
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: BUDESONIDE
CAS Number: 51333-22-3
Conce
Sponsors
DRCI APHP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient = 18 years old - Laboratory proved infection by COVID-19 within 2 days - Hospitalization is required (based on investigator judgement) - Patient affiliated to a social security regime - Patient able to give free, informed and written consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 436 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 436
Exclusion criteria
Exclusion criteria: - 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 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 - Not to be resuscitated decision (co-morbidity, …)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare time to clinical improvement in patients receiving standard of care associated to the combination budesonide/formoterol or standard of care only. ;Secondary Objective: To compare in patients receiving standard of care associated to the combination budesonide/formoterol or standard of care only the : - Mortality - Percentage admitted to ICU - Percentage requiring invasive or non-invasive ventilation - Duration of oxygen therapy - Duration of hospital stay - Number of co-infections - Systemic inflammation - Treatment tolerance. ;Primary end point(s): 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. ;Timepoint(s) of evaluation of this end point: 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Objectives and Endpoints : To compare in patients receiving standard of care associated to the combination budesonide/formoterol or standard of care only the : - Mortality - Percentage admitted to ICU - Percentage requiring invasive or non-invasive ventilation - Duration of oxygen therapy - Duration of hospital stay - Number of co-infections - Systemic inflammation - Treatment tolerance. Secondary Endpoints : - Mortality rate at D30 - Time (in days) from randomization to death - Number of days alive outside ICU within 30 days - Number of days alive free of invasive or non invasive ventilation within 30 days - Number of days alive with oxygen therapy within 30 days - Maximal oxygen rate within 30 days - PaO2/FiO2 ratio at randomization and at Day 7 (or at the time of stopping oxygen therapy or discharge if occurs before Day 7) - Number of days alive outside hospital within 30 days Use of antibiotics for respiratory (proved or suspected) infection within 30 days - CRP levels at randomization and at Day 7 (or at the time of discharge if occurs before Day 7) - Safety outcomes included events that occurred during treatment, serious adverse events, and premature discontinuation of treatment. ;Timepoint(s) of evaluation of this end point: cf below | — |
Countries
France
Contacts
Public ContactVANHOYE
DRCI APHP
Outcome results
None listed