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Clinical trial

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

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Last updated:15th Sep 2020
Status: Recruiting
Identifier: NCT04331054
Protective Role of Inhaled Steroids for Covid-19 Infection (INHASCO)

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

Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 436 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Protective Role of Inhaled Steroids for Covid-19 Infection
Actual Study Start Date: April 13, 2020
Estimated Primary Completion Date: January 13, 2022
Estimated Study Completion Date: January 13, 2022

- Active Comparator: 1: Usual practice
- Experimental: 2: Usual practice + SYMBICORT RAPIHALER

Category Value
Study type(s) Interventional
Expected enrolment 436
Actual Study start date 13 April 2020
Estimated Study Completion Date 13 January 2022

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