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

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.

Study Overview

• Status: Terminated
• Conditions: Covid-19 Infection; Hospitalization in Respiratory Disease Department
• Intervention / Treatment: Other: 1: Usual practice; Drug: 2: Usual practice + SYMBICORT RAPIHALER

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
• Enrollment (Actual): 146
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Paris, France, 75010
    • Hôpital Bichat - Service de Pneumologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1: Usual practice; arm will be follow during 30 days	Other: 1: Usual practice; Usual practice
Experimental: 2: Usual practice + SYMBICORT RAPIHALER; Usual practice + SYMBICORT RAPIHALER 200/6 µg ( 2 puffs bid during 30 days)	Drug: 2: Usual practice + SYMBICORT RAPIHALER; 2 puffs bid during 30 days by inhalation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time (in days) to clinical improvement within 30 days after randomization	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: Not hospitalized with resumption of normal activities; Not hospitalized, but unable to resume normal activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation, or both;; Hospitalized, requiring ECMO, invasive mechanical ventilation, or both; Death. These parameters will be evaluated daily during hospitalization.	within 30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Mortality rate at D30	At day30
Time (in days) from randomization to death	up to 30 days after randomization
Number of days alive outside ICU within 30 days	At day30
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
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
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Camille Taillé, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2020
• Primary Completion (Actual): May 28, 2021
• Study Completion (Actual): May 28, 2021

Study Registration Dates

• First Submitted: March 29, 2020
• First Submitted That Met QC Criteria: April 1, 2020
• First Posted (Actual): April 2, 2020

Study Record Updates

• Last Update Posted (Actual): August 3, 2021
• Last Update Submitted That Met QC Criteria: July 31, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Asthma; Covid-19; Oxygen; Formoterol; Inhaled steroids
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Infections; Communicable Diseases; Respiration Disorders; Respiratory Tract Diseases; Anti-Asthmatic Agents; Respiratory System Agents; Budesonide, Formoterol Fumarate Drug Combination
• Other Study ID Numbers: P 200394; 2020-001306-35 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No