Covid-19 InfectionPhase 3INHASCONCT04331054
Protective Role of Inhaled Steroids for Covid-19 Infection
A Phase 3 study testing 2: Usual practice + SYMBICORT RAPIHALER and 1: Usual practice in people with Covid-19 Infection and Hospitalization in Respiratory Disease Department, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Covid-19 Infection, Hospitalization in Respiratory Disease Department
- What is being tested?
- 2: Usual practice + SYMBICORT RAPIHALER and 1: Usual practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteFrance
- Study dates
- 13 Apr 2020to 28 May 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- 2: Usual practice + SYMBICORT RAPIHALER, 1: Usual practice
- Keywords
- Covid-19, Asthma, Inhaled steroids, Formoterol, Oxygen
- Medical subject headings
- COVID-19, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2: Usual practice + SYMBICORT RAPIHALERDrug
2 puffs bid during 30 days by inhalation
1: Usual practiceOther
Usual practice
| Study group | Role | What they receive |
|---|---|---|
| 1: Usual practice | Active comparator | arm will be follow during 30 days Receives: Other: 1: Usual practice |
| 2: Usual practice + SYMBICORT RAPIHALER | Experimental | Usual practice + SYMBICORT RAPIHALER 200/6 µg ( 2 puffs bid during 30 days) Receives: Drug: 2: Usual practice + SYMBICORT RAPIHALER |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 30 days
Secondary outcomes (11)
Mortality rate at D30
Measured: At day30
Time (in days) from randomization to death
Measured: up to 30 days after randomization
Number of days alive outside ICU within 30 days
Measured: At day30
Number of days alive free of invasive or non-invasive ventilation within 30 days
Measured: At day30
Number of days alive with oxygen therapy within 30 days
Measured: At day30
Maximal oxygen rate within 30 days
Measured: 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)
Measured: at Day 7
Number of days alive outside hospital within 30 days
Measured: at Day 30
Use of antibiotics for respiratory (proved or suspected) infection within 30 days
Measured: at Day 30
Difference between CRP levels at randomization and at Day 7 (or at the time of discharge if occurs before Day 7)
Measured: at Day 7
Safety outcomes included events that occurred during treatment, serious adverse events, and premature discontinuation of treatment.
Measured: up to 30 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start13 Apr 2020
- Primary completion28 May 2021
- Study completion28 May 2021
Why it stopped: Insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19 InfectionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Camille TAILLE, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331054
- Sponsor's protocol ID
- P 200394
- Other IDs
- 2020-001306-35
- Acronym
- INHASCO
- Status last verified
- Jul 2021
- First submitted
- 29 Mar 2020
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Role of Inhaled Steroids for Covid-19 Infection
- ClinicalTrials.gov ID
- NCT04331054
- Acronym / sponsor ID
- INHASCO / P 200394
- Keywords
- Covid-19, Asthma, Inhaled steroids, Formoterol, Oxygen
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 13 Apr 2020 (actual)
- Primary completion
- 28 May 2021 (actual)
- Study completion
- 28 May 2021 (actual)
- First posted
- 2 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: Usual practice | Active comparator | Other: 1: Usual practicearm will be follow during 30 days |
| 2: Usual practice + SYMBICORT RAPIHALER | Experimental | Drug: 2: Usual practice + SYMBICORT RAPIHALERUsual practice + SYMBICORT RAPIHALER 200/6 µg ( 2 puffs bid during 30 days) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2: Usual practice + SYMBICORT RAPIHALER2 puffs bid during 30 days by inhalation | Drug | 2: Usual practice + SYMBICORT RAPIHALER |
| 1: Usual practiceUsual practice | Other | 1: Usual practice |
Primary outcome
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.
11 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Camille TAILLE, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 2: Usual practice + SYMBICORT RAPIHALER and 1: Usual practice in people with Covid-19 Infection and Hospitalization in Respiratory Disease Department, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time (in days) to clinical improvement within 30 days after randomization (time frame: within 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.