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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04331054
Recruitment Status : Terminated (Insufficient recruitment)
First Posted : April 2, 2020
Last Update Posted : August 3, 2021
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE March 29, 2020
First Posted Date  ICMJE April 2, 2020
Last Update Posted Date August 3, 2021
Actual Study Start Date  ICMJE April 13, 2020
Actual Primary Completion Date May 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2020)
  • Mortality rate at D30 [ Time Frame: At day30 ]
  • Time (in days) from randomization to death [ Time Frame: up to 30 days after randomization ]
  • Number of days alive outside ICU within 30 days [ Time Frame: At day30 ]
  • Number of days alive free of invasive or non-invasive ventilation within 30 days [ Time Frame: At day30 ]
  • Number of days alive with oxygen therapy within 30 days [ Time Frame: At day30 ]
  • Maximal oxygen rate within 30 days [ Time Frame: 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) [ Time Frame: at Day 7 ]
  • Number of days alive outside hospital within 30 days [ Time Frame: at Day 30 ]
  • Use of antibiotics for respiratory (proved or suspected) infection within 30 days [ Time Frame: at Day 30 ]
  • 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 ]
  • Safety outcomes included events that occurred during treatment, serious adverse events, and premature discontinuation of treatment. [ Time Frame: up to 30 days after randomization ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Protective Role of Inhaled Steroids for Covid-19 Infection
Official Title  ICMJE Protective Role of Inhaled Steroids for Covid-19 Infection
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Covid-19 Infection
  • Hospitalization in Respiratory Disease Department
Intervention  ICMJE
  • Drug: 2: Usual practice + SYMBICORT RAPIHALER
    2 puffs bid during 30 days by inhalation
  • Other: 1: Usual practice
    Usual practice
Study Arms  ICMJE
  • Active Comparator: 1: Usual practice
    arm will be follow during 30 days
    Intervention: Other: 1: Usual practice
  • Experimental: 2: Usual practice + SYMBICORT RAPIHALER
    Usual practice + SYMBICORT RAPIHALER 200/6 µg ( 2 puffs bid during 30 days)
    Intervention: Drug: 2: Usual practice + SYMBICORT RAPIHALER
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 31, 2021)
146
Original Estimated Enrollment  ICMJE
 (submitted: April 1, 2020)
436
Actual Study Completion Date  ICMJE May 28, 2021
Actual Primary Completion Date May 28, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04331054
Other Study ID Numbers  ICMJE P 200394
2020-001306-35 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Assistance Publique - Hôpitaux de Paris
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Camille TAILLE, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP