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Effect of Treatments in Patients Hospitalized for Severe COVID-19 Pneumonia: a Multicenter Cohort Study

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ClinicalTrials.gov Identifier: NCT04365764
Recruitment Status : Recruiting
First Posted : April 28, 2020
Last Update Posted : May 20, 2020
Sponsor:
Collaborators:
Centre Hospitalier Intercommunal Robert Ballanger
Centre Hospitalier Intercommunal Montfermeil-Le Raincy
CMC Ambroise Paré
Information provided by (Responsible Party):
Lee S Nguyen, Groupe Hospitalier Pitie-Salpetriere

Brief Summary:
Several treatments have been used in during the Covid-19 pandemic of 2020. Using patients' registries from several hospitals in Paris, the investigators retrospectively analyzed associations between specific treatments, including but not limited to hydroxychloroquine, azithromycin, remdesivir, baricitinib, tocilizumab, sarilumab, lopinavir/ritonavir and oseltamivir; and clinical outcomes including, death and mechanical ventilation.

Condition or disease
Covid-19 ARDS Pneumonia

Detailed Description:

Several treatments have been used in during the Covid-19 pandemic of 2020. Using patients' registries from several hospitals in Paris, the investigators retrospectively analyzed associations between specific treatments, including but not limited to hydroxychloroquine, azithromycin, remdesivir, baricitinib, tocilizumab, sarilumab, lopinavir/ritonavir and oseltamivir; and clinical outcomes including, death and mechanical ventilation.

Other outcomes of interest include: acute kidney injury, encephalopathy, need for intensive care unit transfers.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Effect of Treatments in Patients Hospitalized for Severe COVID-19 Pneumonia: a Multicenter Cohort Study
Actual Study Start Date : March 14, 2020
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Group/Cohort
Exposed to the treatment
Exposure variable will be studied treatment
Not exposer to the treatment (control group)



Primary Outcome Measures :
  1. Composite of death and mechanical ventilation [ Time Frame: 14-days follow-up ]
    Composite of death and mechanical ventilation (i.e. intubation)


Secondary Outcome Measures :
  1. Death [ Time Frame: 14-days follow-up ]
    Death

  2. Mechanical ventilation [ Time Frame: 14-days follow-up ]
    Enabled by intubation

  3. Composite of death and mechanical ventilation [ Time Frame: 28-days follow-up ]
    Composite of death and mechanical ventilation

  4. World Health Organization score [ Time Frame: 14-days follow-up ]
    World Health Organization score

  5. World Health Organization score [ Time Frame: 28-days follow-up ]
    World Health Organization score



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population is cohort-base in routine care, in medical departments.
Criteria

Inclusion Criteria:

  • admitted for severe Covid-19 pneumonia (i.e. requiring O2-support more than 6L/min with SpO2<96%)

Exclusion Criteria:

  • patients who were previously in ICU
  • patients already hospitalized prior to study start date
  • patients in palliative care
  • lack of consent

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): NCT04365764


Contacts
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Contact: Joe-Elie Salem, MD, PhD 01 42 16 00 00 ext +33 joe-elie.salem@aphp.fr

Locations
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France
Centre Hospitalier Intercommunal Robert Ballanger Recruiting
Aulnay-sous-Bois, France
Contact: Hélène Gros, MD         
Centre Hospitalier Intercommunal Le Raincy-Montfermeil Recruiting
Montfermeil, France
Contact: Anis Saib, MD         
Sponsors and Collaborators
Groupe Hospitalier Pitie-Salpetriere
Centre Hospitalier Intercommunal Robert Ballanger
Centre Hospitalier Intercommunal Montfermeil-Le Raincy
CMC Ambroise Paré

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Responsible Party: Lee S Nguyen, Study coordinator, Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier: NCT04365764    
Other Study ID Numbers: CIC1421-20-06
First Posted: April 28, 2020    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD may be available on request.

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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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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections