Effect of Corticosteroid Treatment on Prognosis in ARDS Secondary to Covid-19

Acute Respiratory Distress Syndrome Secondary to Covid-19 Clinical Trial

— CoCovSDRA  

Official title:

Effect of Early Corticosteroid Therapy on Mortality in Patient With Acute Respiratory Distress Syndrome Secondary to Covid-19

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04586114
• Other study ID #: 2020PI109
• Status: Active, not recruiting
• Start date: March 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2020
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome Secondary to Covid-19
• Neoplasm Metastasis
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Drug:
• Corticosteroids and Derivatives
Any systemic corticosteroid treatment administrated during ICU stay

Locations

Country	Name	City	State
France	Hopital Central, Service de Reanimation Medicale	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

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