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Protective Role of Inhaled Steroids for Covid-19 Infection

Trial Profile

Protective Role of Inhaled Steroids for Covid-19 Infection

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 20 Apr 2020

At a glance

  • Drugs Budesonide/formoterol (Primary)
  • Indications COVID 2019 infections
  • Focus Therapeutic Use
  • Acronyms INHASCO
  • Most Recent Events

    • 16 Apr 2020 Planned End Date changed from 1 Jul 2020 to 13 Jul 2020.
    • 16 Apr 2020 Planned primary completion date changed from 1 Jul 2020 to 13 Jul 2020.
    • 16 Apr 2020 Status changed from not yet recruiting to recruiting.

Trial Overview

Purpose

To compare time to clinical improvement in patients receiving standard of care associated to the combination budesonide/formoterol or standard of care only.

Primary Endpoints

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

Other Endpoints

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 [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 872

  • Sex male & female
  • Age Group 18-75 years; adult; elderly

Patient Inclusion Criteria

Inclusion criera : - Patient ≥ 18 years old and ≤ 75 years old - Laboratory proved infection by COVID-19 by RT-PCR on a nasopharyngeal 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

Patient 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

Trial Details

Identifiers

Identifier Owner
NCT04331054 ClinicalTrials.gov: US National Institutes of Health
EudraCT2020-001306-35 European Clinical Trials Database
APHP200394 -
P200394 -

Trial Dates

  • Initiation Dates

    Planned : 01 Apr 2020

    Actual : 13 Apr 2020

  • Primary Completion Dates

    Planned : 13 Jul 2020

  • End Dates

    Planned : 13 Jul 2020

Other Details

  • Design open; parallel; prospective; randomised
  • Phase of Trial Phase III
  • Location France
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
Budesonide/formoterolPrimary Drug Inhalation Solution

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)

1: Usual practice

arm will be follow during 30 days
Other: 1: Usual practice (Usual practice)

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Bruno CRESTANI, MD, PhD
+33 1 40 25 68 00 bruno.crestani@aphp.fr
show details
-
Camille TAILLE, MD, PhD
+33 1 40 25 68 63
camille.taille@aphp.fr
show details
Assistance Publique - Hopitaux de Paris, Hôpital Bichat - Service de Pneumologie France
VANHOYE
1 avenue Claude Vellefaux
PARIS
France
damien.vanhoye@aphp.fr
show details
DRCI APHP France

Centres

Centre Name Location Trial Centre Country
-
-
-
Assistance Publique - Hopitaux de Paris
-
-
DRCI APHP PARIS France
Hôpital Bichat - Service de Pneumologie Paris France

Trial History

Event Date Event Type Comment
20 Apr 2020 Other trial event Last checked against ClinicalTrials.gov record. Updated 20 Apr 2020
16 Apr 2020 Completion date Planned End Date changed from 1 Jul 2020 to 13 Jul 2020. Updated 20 Apr 2020
16 Apr 2020 Other trial event Planned primary completion date changed from 1 Jul 2020 to 13 Jul 2020. Updated 20 Apr 2020
16 Apr 2020 Status change - recruiting Status changed from not yet recruiting to recruiting. Updated 20 Apr 2020
14 Apr 2020 Other trial event New source identified and integrated Updated 14 Apr 2020
09 Apr 2020 Status change - not yet recruiting Status changed from recruiting to not yet recruiting. Updated 14 Apr 2020
08 Apr 2020 New trial record New trial record Updated 08 Apr 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. European Clinical Trials Database. Trial-Reg 2016;.

    Available from: URL: https://www.clinicaltrialsregister.eu
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