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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04586114
Recruitment Status : Active, not recruiting
First Posted : October 14, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Acute Respiratory Distress Syndrome Secondary to Covid-19 Drug: Corticosteroids and Derivatives

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Effect of Early Corticosteroid Therapy on Mortality in Patient With Acute Respiratory Distress Syndrome Secondary to Covid-19
Actual Study Start Date : March 1, 2020
Actual Primary Completion Date : May 31, 2020
Estimated Study Completion Date : December 31, 2020


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



Primary Outcome Measures :
  1. Mortality in ICU [ Time Frame: within ICU stay, on average 15 days ]
    Mortality rates in ICU in each group


Secondary Outcome Measures :
  1. Mortality d28 [ Time Frame: 28 days ]
    mortality at day 28 after ICU admission

  2. acquired infections incidence [ Time Frame: 28 days ]
    cumulative incidence of infection acquired during ICU stay

  3. antibiotics duration [ Time Frame: 28 days ]
    number of treatment days with antibiotics during ICU stay

  4. mechanical ventilation duration [ Time Frame: 28 days ]
    number of days of treatment by mechanical ventilation during ICU stay



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04586114


Locations
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France
Hopital Central, Service de Reanimation Medicale
Nancy, France, 54000
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Sebastien GIBOT Central Hospital, Nancy, France
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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT04586114    
Other Study ID Numbers: 2020PI109
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Neoplastic Processes
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury