NCT04331054

Protective Role of Inhaled Steroids for Covid-19 Infection

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Covid-19 Infection
• Hospitalization in Respiratory Disease Department

Interventions

Type	Name	Description
DRUG	2: Usual practice + SYMBICORT RAPIHALER	2 puffs bid during 30 days by inhalation
OTHER	1: Usual practice	Usual practice

Timeline

• Start date: 2020-04-13
• Primary completion: 2021-05-28
• Completion: 2021-05-28
• First posted: 2020-04-02
• Last updated: 2021-08-03

Locations

1 site across 1 country: France