Protective Role of Inhaled Steroids for Covid-19 Infection

NCT ID: NCT04331054

Last Updated: 2021-08-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-13
• Study Completion Date: 2021-05-28

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

Conditions

Covid-19 Infection; Hospitalization in Respiratory Disease Department

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1: Usual practice

arm will be follow during 30 days

Group Type: ACTIVE_COMPARATOR

1: Usual practice

Intervention Type: OTHER

Usual practice

2: Usual practice + SYMBICORT RAPIHALER

Usual practice + SYMBICORT RAPIHALER 200/6 µg ( 2 puffs bid during 30 days)

Group Type: EXPERIMENTAL

2: Usual practice + SYMBICORT RAPIHALER

Intervention Type: DRUG

2 puffs bid during 30 days by inhalation

Interventions

2: Usual practice + SYMBICORT RAPIHALER

2 puffs bid during 30 days by inhalation

Intervention Type: DRUG

1: Usual practice

Usual practice

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Camille TAILLE, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Bichat - Service de Pneumologie

Paris, , France

Countries

France

Other Identifiers

2020-001306-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

P 200394

Identifier Type: -

Identifier Source: org_study_id