Protective Role of Inhaled Steroids for Covid-19 Infection
Latest Information Update: 04 Nov 2021
At a glance
- Drugs Budesonide/formoterol (Primary)
- Indications COVID 2019 infections
- Focus Therapeutic Use
- Acronyms INHASCO
- 31 Jul 2021 Status changed from active, no longer recruiting to discontinued due to insufficient recruitment.
- 14 May 2021 Status changed from discontinued to active, no longer recruiting.
- 14 May 2021 Planned number of patients changed from 872 to 436.
Most Recent Events
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.
Comments
According to ClinicalTrials.gov: US National Institutes of Health record, this study has been discontinued due to insufficient recruitment.
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 | - |
Biomarker
| NCT Number | Biomarker Name | Biomarker Function |
|---|---|---|
| NCT04331054 | C-reactive protein (CRP) | Outcome Measure |
| CGA | Eligibility Criteria | |
| chorionic gonadotropin beta subunit 5 | Eligibility Criteria | |
| hypertrichosis 2 (generalized, congenital) | Eligibility Criteria |
Subjects
- Subject Type patients
-
Number
Planned: 436
Actual: 146
- 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 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
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 Jan 2022
Actual : 28 May 2021
-
End Dates
Planned : 13 Jan 2022
Actual : 28 May 2021
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
show details
camille.taille@aphp.fr |
Assistance Publique - Hopitaux de Paris, Hôpital Bichat - Service de Pneumologie | France |
|
VANHOYE
1 avenue Claude Vellefaux
show details
PARIS France damien.vanhoye@aphp.fr |
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 |
|---|---|---|
| 05 Aug 2021 | Other trial event | Last checked against ClinicalTrials.gov record. Updated 05 Aug 2021 |
| 03 Aug 2021 | Biomarker Update | Biomarkers information updated Updated 04 Nov 2021 |
| 31 Jul 2021 | Status change - discontinued | Status changed from active, no longer recruiting to discontinued due to insufficient recruitment. Updated 05 Aug 2021 |
| 14 May 2021 | Status change - active, no longer recruiting | Status changed from discontinued to active, no longer recruiting. Updated 19 May 2021 |
| 14 May 2021 | Other trial event | Planned number of patients changed from 872 to 436. Updated 19 May 2021 |
| 29 Apr 2021 | Other trial event | Last checked against European Clinical Trials Database record. Updated 29 Apr 2021 |
| 29 Apr 2021 | Status change - discontinued | Status changed from recruiting to discontinued. Updated 29 Apr 2021 |
| 14 Sep 2020 | Completion date | Planned End Date changed from 13 Jul 2020 to 13 Jan 2022. Updated 16 Sep 2020 |
| 14 Sep 2020 | Other trial event | Planned primary completion date changed from 13 Jul 2020 to 13 Jan 2022. Updated 16 Sep 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
-
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov -
European Clinical Trials Database. Trial-Reg 2023;.
Available from: URL: https://www.clinicaltrialsregister.eu
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