Protective Role of Inhaled Steroids for Covid-19 Infection (INHASCO)
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| ClinicalTrials.gov Identifier: NCT04331054 |
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Recruitment Status: Terminated(Insufficient recruitment)
First Posted: April 2, 2020
Last Update Posted: August 3, 2021
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| 新冠肺炎InfectionHospitalization in Respiratory Disease Department | Drug: 2: Usual practice + SYMBICORT RAPIHALEROther: 1: Usual practice | Phase 3 |
D1包容 /随机化访问：
符合资格标准并在48小时内证实其感染COVID-19的患者将由呼吸道疾病部门纳入呼吸道疾病部门。
患者将被随机分为对照组或干预组。对于介入的患者，试验治疗（Symbicort Rapihaler 200/6 µ）将在12小时内开始。
Follow-up period (D2 to D29) and end of study visit (D30):
在他们住院,病人将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: | 介入(临床试验) |
| ActualEnrollment: | 146 participants |
| Allocation: | Randomized |
| 干预模型： | Parallel Assignment |
| 掩蔽： | 不ne (Open Label) |
| Primary Purpose: | 治疗 |
| Official Title: | Protective Role of Inhaled Steroids for Covid-19 Infection |
| ActualStudy Start Date: | April 13, 2020 |
| ActualPrimary Completion Date: | May 28, 2021 |
| ActualStudy Completion Date: | May 28, 2021 |
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: 1: Usual practice
arm will be follow during 30 days |
Other: 1: Usual practice
Usual practice |
| Experimental: 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 |
- 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:
- 未在正常活动中恢复住院
- 不t 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.
- 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 ]
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 接受健康的志愿者： | 不 |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number):NCT04331054
| 法国 | |
| Hôpital Bichat - Service de Pneumologie | |
| Paris, France, 75010 | |
| Principal Investigator: | Camille TAILLE, MD, PhD | Assistance Publique - Hôpitaux de Paris |
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT04331054 |
| Other Study ID Numbers: | P 200394 2020-001306-35 ( EudraCT Number ) |
| First Posted: | April 2, 2020Key Record Dates |
| Last Update Posted: | August 3, 2021 |
| Last Verified: | July 2021 |
| Studies a U.S. FDA-regulated Drug Product: | 不 |
| Studies a U.S. FDA-regulated Device Product: | 不 |
| 新冠肺炎 Asthma Inhaled steroids Formoterol Oxygen |
| Infections Communicable Diseases COVID-19 Respiration Disorders Respiratory Tract Diseases Disease Attributes Pathologic Processes Respiratory Tract Infections Pneumonia, Viral Pneumonia |
病毒疾病 Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases 布德斯奈德，福托赛富马酸药物组合 Anti-Asthmatic Agents Respiratory System Agents |