Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04331054
Other study ID # P 200394
Secondary ID 2020-001306-35
Status Terminated
Phase Phase 3
First received
Last updated
Start date April 13, 2020
Est. completion date May 28, 2021

Study information

Verified date July 2021
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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


Recruitment information / eligibility

Status Terminated
Enrollment 146
Est. completion date May 28, 2021
Est. primary completion date May 28, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 ß-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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
2: Usual practice + SYMBICORT RAPIHALER
2 puffs bid during 30 days by inhalation
Other:
1: Usual practice
Usual practice

Locations

Country Name City State
France Hôpital Bichat - Service de Pneumologie Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
within 30 days
Secondary Mortality rate at D30 At day30
Secondary Time (in days) from randomization to death up to 30 days after randomization
Secondary Number of days alive outside ICU within 30 days At day30
Secondary Number of days alive free of invasive or non-invasive ventilation within 30 days At day30
Secondary Number of days alive with oxygen therapy within 30 days At day30
Secondary Maximal oxygen rate within 30 days At day30
Secondary 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) at Day 7
Secondary Number of days alive outside hospital within 30 days at Day 30
Secondary Use of antibiotics for respiratory (proved or suspected) infection within 30 days at Day 30
Secondary Difference between CRP levels at randomization and at Day 7 (or at the time of discharge if occurs before Day 7) at Day 7
Secondary Safety outcomes included events that occurred during treatment, serious adverse events, and premature discontinuation of treatment. up to 30 days after randomization
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04997551 - Double Blind Randomized Clinical Trial of Use of Colchicine Added to Standard Treatment in Hospitalized With Covid-19 Phase 3
Recruiting NCT04977024 - SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA SARS-COV-2 Vaccine in Patients With Blood Cancer Phase 2
Completed NCT05049226 - Third Dose Vaccination With AstraZeneca or Pfizer COVID-19 Vaccine Among Adults Received Sinovac COVID-19 Vaccine Phase 2
Terminated NCT04455815 - A Trial Looking at the Use of Camostat in People Who Have Tested Positive for Coronavirus (COVID-19) (SPIKE-1) Phase 2
Completed NCT04666025 - SARS-CoV-2 Donor-Recipient Immunity Transfer
Completed NCT04662437 - The Status of Parathyroid Hormone Secretion in Covid-19 Patients
Recruiting NCT05792878 - Study of COVID-19 Infection and Its Clinical Prognosis in Chronic Hepatitis B Patients With Antiviral Therapy
Completed NCT04659200 - Thyroid Function Tests and Status of Thyroid Autoantibodies in Covid-19 Patients
Recruiting NCT04470583 - Evaluating Clinical Parameters of COVID-19 in Pregnancy
Withdrawn NCT04377568 - Efficacy of Human Coronavirus-immune Convalescent Plasma for the Treatment of COVID-19 Disease in Hospitalized Children Phase 2
Completed NCT04848610 - The Factors That Affect the Infection of COVID-19
Recruiting NCT04582903 - Send-In Sample Collection for Comprehensive Analyses of Innate and Adaptive Immune Responses During Acute COVID-19 and Convalescence
Recruiting NCT06032000 - Evaluation of Safety and Immunogenicity of a SARS-CoV-2(Severe Acute Respiratory Syndrome Coronavirus 2) Booster Vaccine (LEM-mR203) Phase 1
Terminated NCT04941703 - "CHANGE COVID-19 Severity" Phase 1/Phase 2
Active, not recruiting NCT04639466 - A Synthetic MVA-based SARS-CoV-2 Vaccine, GEO-CM04S1, for the Prevention of COVID-19 Infection Phase 1/Phase 2
Completed NCT04575038 - CRISIS2: A Phase 2 Study of the Safety and Antiviral Activity of Brequinar in Non-hospitalized Pts With COVID-19 Phase 2
Recruiting NCT05022446 - The Impact of COVID-19 on Pulmonary Procedures
Completed NCT04347798 - IMPACT: IMPact of Antimalarials on Covid-19 Infections in RAPPORT
Active, not recruiting NCT04650178 - Well-being in Cancer Patients With Neuropathy During COVID-19 Who Participated in Prior Clinical Trials
Recruiting NCT04169542 - Impact of COVID-19 Pandemic on Out-of-Pocket Costs, Lost Wages, and Unemployment in Patients With Breast Cancer Undergoing Breast Surgery