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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04331054
Recruitment Status : Recruiting
First Posted : April 2, 2020
Last Update Posted : September 15, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment Phase
Covid-19 Infection Hospitalization in Respiratory Disease Department Drug: 2: Usual practice + SYMBICORT RAPIHALER Other: 1: Usual practice Phase 3

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

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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

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




Primary Outcome Measures :
  1. Time (in days) to clinical improvement within 30 days after randomization [ Time Frame: within 30 days ]

    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:

    1. Not hospitalized with resumption of normal activities
    2. Not hospitalized, but unable to resume normal activities
    3. Hospitalized, not requiring supplemental oxygen
    4. Hospitalized, requiring supplemental oxygen
    5. Hospitalized, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation, or both;
    6. Hospitalized, requiring ECMO, invasive mechanical ventilation, or both
    7. Death.

    These parameters will be evaluated daily during hospitalization.



Secondary Outcome Measures :
  1. Mortality rate at D30 [ Time Frame: At day30 ]
  2. Time (in days) from randomization to death [ Time Frame: up to 30 days after randomization ]
  3. Number of days alive outside ICU within 30 days [ Time Frame: At day30 ]
  4. Number of days alive free of invasive or non-invasive ventilation within 30 days [ Time Frame: At day30 ]
  5. Number of days alive with oxygen therapy within 30 days [ Time Frame: At day30 ]
  6. Maximal oxygen rate within 30 days [ Time Frame: At day30 ]
  7. 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) [ Time Frame: at Day 7 ]
  8. Number of days alive outside hospital within 30 days [ Time Frame: at Day 30 ]
  9. Use of antibiotics for respiratory (proved or suspected) infection within 30 days [ Time Frame: at Day 30 ]
  10. Difference between CRP levels at randomization and at Day 7 (or at the time of discharge if occurs before Day 7) [ Time Frame: at Day 7 ]
  11. Safety outcomes included events that occurred during treatment, serious adverse events, and premature discontinuation of treatment. [ Time Frame: up to 30 days after randomization ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04331054


Contacts
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Contact: Camille TAILLE, MD, PhD +33 1 40 25 68 63 camille.taille@aphp.fr
Contact: Bruno CRESTANI, MD, PhD +33 1 40 25 68 00 bruno.crestani@aphp.fr

Locations
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France
Hôpital Bichat - Service de Pneumologie Recruiting
Paris, France, 75010
Contact: Camille TAILLE, MD, PhD    +33 1 40 25 68 63    camille.taille@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Camille TAILLE, MD, PhD Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04331054    
Other Study ID Numbers: P 200394
2020-001306-35 ( EudraCT Number )
First Posted: April 2, 2020    Key Record Dates
Last Update Posted: September 15, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Covid-19
Asthma
Inhaled steroids
Formoterol
Oxygen
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiration Disorders
Respiratory Tract Diseases
Budesonide, Formoterol Fumarate Drug Combination
Anti-Asthmatic Agents
Respiratory System Agents