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

Primary Purpose

Covid-19 Infection, Hospitalization in Respiratory Disease Department

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
2: Usual practice + SYMBICORT RAPIHALER
1: Usual practice
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid-19 Infection focused on measuring Covid-19, Asthma, Inhaled steroids, Formoterol, Oxygen

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Bichat - Service de Pneumologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1: Usual practice

2: Usual practice + SYMBICORT RAPIHALER

Arm Description

arm will be follow during 30 days

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 29, 2020
Last Updated
July 31, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT04331054
Brief Title
Protective Role of Inhaled Steroids for Covid-19 Infection
Acronym
INHASCO
Official Title
Protective Role of Inhaled Steroids for Covid-19 Infection
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
Insufficient recruitment
Study Start Date
April 13, 2020 (Actual)
Primary Completion Date
May 28, 2021 (Actual)
Study Completion Date
May 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19 Infection, Hospitalization in Respiratory Disease Department
Keywords
Covid-19, Asthma, Inhaled steroids, Formoterol, Oxygen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1: Usual practice
Arm Type
Active Comparator
Arm Description
arm will be follow during 30 days
Arm Title
2: Usual practice + SYMBICORT RAPIHALER
Arm Type
Experimental
Arm Description
Usual practice + SYMBICORT RAPIHALER 200/6 µg ( 2 puffs bid during 30 days)
Intervention Type
Drug
Intervention Name(s)
2: Usual practice + SYMBICORT RAPIHALER
Intervention Description
2 puffs bid during 30 days by inhalation
Intervention Type
Other
Intervention Name(s)
1: Usual practice
Intervention Description
Usual practice
Primary Outcome Measure Information:
Title
Time (in days) to clinical improvement within 30 days after randomization
Description
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.
Time Frame
within 30 days
Secondary Outcome Measure Information:
Title
Mortality rate at D30
Time Frame
At day30
Title
Time (in days) from randomization to death
Time Frame
up to 30 days after randomization
Title
Number of days alive outside ICU within 30 days
Time Frame
At day30
Title
Number of days alive free of invasive or non-invasive ventilation within 30 days
Time Frame
At day30
Title
Number of days alive with oxygen therapy within 30 days
Time Frame
At day30
Title
Maximal oxygen rate within 30 days
Time Frame
At day30
Title
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
Title
Number of days alive outside hospital within 30 days
Time Frame
at Day 30
Title
Use of antibiotics for respiratory (proved or suspected) infection within 30 days
Time Frame
at Day 30
Title
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
Title
Safety outcomes included events that occurred during treatment, serious adverse events, and premature discontinuation of treatment.
Time Frame
up to 30 days after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camille TAILLE, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Bichat - Service de Pneumologie
City
Paris
ZIP/Postal Code
75010
Country
France

12. IPD Sharing Statement

Learn more about this trial

Protective Role of Inhaled Steroids for Covid-19 Infection

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