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

• Conditions: Acute Respiratory Distress Syndrome Secondary to Covid-19
• Interventions: Drug: Corticosteroids and Derivatives

• Registration Number: NCT04586114
• Lead Sponsor: Central Hospital, Nancy, France

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-01
• Primary Completion: 2020-05-31
• Status Verified: 2020-10
• Study First Submitted: 2020-10-08
• Study First Submitted QC: 2020-10-13
• Study First Posted: 2020-10-14
• Last Update Submitted: 2020-10-16
• Last Update Posted: 2020-10-19
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Early corticosteroid	Corticosteroids and Derivatives	Corticosteroid treatment within first seven days after ICU admission
Late corticosteroid	Corticosteroids and Derivatives	Corticosteroid treatment later than seventh day's after ICU admission

Primary Outcome Measures

Name	Time	Method
Mortality in ICU	within ICU stay, on average 15 days	Mortality rates in ICU in each group

Secondary Outcome Measures

Name	Time	Method
acquired infections incidence	28 days	cumulative incidence of infection acquired during ICU stay
antibiotics duration	28 days	number of treatment days with antibiotics during ICU stay
Mortality d28	28 days	mortality at day 28 after ICU admission
mechanical ventilation duration	28 days	number of days of treatment by mechanical ventilation during ICU stay

Trial Locations

Locations (1)

Hopital Central, Service de Reanimation Medicale; 🇫🇷 Nancy, France