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

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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Respiratory Distress Syndrome Secondary to Covid-19
• Intervention / Treatment: Drug: Corticosteroids and Derivatives

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• France
  • Nancy, France, 54000
    • Hopital Central, Service de Reanimation Medicale

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient more than 18 years old hospitalized in ICU from 01/03/2020 to 30/04/2020 with acute respiratory distress syndrome secondary to Sars-Cov-2 infection without any corticosteroid treatment before admission, excluding patients with mechanical ventilation more than 48 hours before admission and patients transferred to other ICU.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Early corticosteroid; Corticosteroid treatment within first seven days after ICU admission	Drug: Corticosteroids and Derivatives; Any systemic corticosteroid treatment administrated during ICU stay
Late corticosteroid; Corticosteroid treatment later than seventh day's after ICU admission	Drug: Corticosteroids and Derivatives; Any systemic corticosteroid treatment administrated during ICU stay
No corticosteroid; No corticosteroid treatment during ICU stay

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality in ICU	Mortality rates in ICU in each group	within ICU stay, on average 15 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Sebastien GIBOT, Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): May 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: October 8, 2020
• First Submitted That Met QC Criteria: October 13, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 16, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Neoplasms; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease; Infant, Newborn, Diseases; Neoplastic Processes; Lung Injury; Infant, Premature, Diseases; COVID-19; Syndrome; Neoplasm Metastasis; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: 2020PI109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No