Protective Role of Inhaled Steroids for Covid-19 Infection

Covid-19 Infection Clinical Trial

— INHASCO  

Official title:

Protective Role of Inhaled Steroids for Covid-19 Infection

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04331054
• Other study ID #: P 200394
• Secondary ID: 2020-001306-35
• Status: Terminated
• Phase: Phase 3
• Start date: April 13, 2020
• Est. completion date: May 28, 2021

Study information

• Verified date: July 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 146
• Est. completion date: May 28, 2021
• Est. primary completion date: May 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Communicable Diseases
• Covid-19 Infection
• Hospitalization in Respiratory Disease Department
• Infection
• Respiration Disorders
• Respiratory Tract Diseases

Intervention

Drug:
• 2: Usual practice + SYMBICORT RAPIHALER
2 puffs bid during 30 days by inhalation

Other:
• 1: Usual practice
Usual practice

Locations

Country	Name	City	State
France	Hôpital Bichat - Service de Pneumologie	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mortality rate at D30		At day30
Secondary	Time (in days) from randomization to death		up to 30 days after randomization
Secondary	Number of days alive outside ICU within 30 days		At day30
Secondary	Number of days alive free of invasive or non-invasive ventilation within 30 days		At day30
Secondary	Number of days alive with oxygen therapy within 30 days		At day30
Secondary	Maximal oxygen rate within 30 days		At day30
Secondary	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
Secondary	Number of days alive outside hospital within 30 days		at Day 30
Secondary	Use of antibiotics for respiratory (proved or suspected) infection within 30 days		at Day 30
Secondary	Difference between CRP levels at randomization and at Day 7 (or at the time of discharge if occurs before Day 7)		at Day 7
Secondary	Safety outcomes included events that occurred during treatment, serious adverse events, and premature discontinuation of treatment.		up to 30 days after randomization