Acute Respiratory Distress Syndrome Secondary to Covid-19 Clinical Trial
— CoCovSDRAOfficial title:
Effect of Early Corticosteroid Therapy on Mortality in Patient With Acute Respiratory Distress Syndrome Secondary to Covid-19
Verified date | October 2020 |
Source | Central Hospital, Nancy, France |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Study conducted on hospitalized patient in critical ill units in Nancy and Metz to evaluate if early corticosteroid treatment in first seven days after admission improve patients outcome in Acute Respiratory Distress Syndrome secondary to Covid-19 compared to later corticosteroid therapy or no treatment. Also comparison of acquired infection with or without corticosteroid treatment during hospitalisation.
Status | Active, not recruiting |
Enrollment | 200 |
Est. completion date | December 31, 2020 |
Est. primary completion date | May 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - ICU hospitalized with acute respiratory distress syndrome secondary to Sars-Cov-2 infection diagnosed by PCR test - Hospitalized from 01/03/2020 to 30/04/2020 Exclusion Criteria: - Mechanical ventilation more than 48 hours at admission - Transfert to another ICU during stay for bed management - Corticosteroid treatment at admission |
Country | Name | City | State |
---|---|---|---|
France | Hopital Central, Service de Reanimation Medicale | Nancy |
Lead Sponsor | Collaborator |
---|---|
Central Hospital, Nancy, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mortality in ICU | Mortality rates in ICU in each group | within ICU stay, on average 15 days | |
Secondary | Mortality d28 | mortality at day 28 after ICU admission | 28 days | |
Secondary | acquired infections incidence | cumulative incidence of infection acquired during ICU stay | 28 days | |
Secondary | antibiotics duration | number of treatment days with antibiotics during ICU stay | 28 days | |
Secondary | mechanical ventilation duration | number of days of treatment by mechanical ventilation during ICU stay | 28 days |