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NCT04365764 Clinical Trial

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

Covid-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04365764
Other study ID # CIC1421-20-06
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 14, 2020
Est. completion date December 31, 2022

Study information
Verified date April 2023
Source Groupe Hospitalier Pitie-Salpetriere
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 vaccines targeted against SARS-CoV-2, hydroxychloroquine, azithromycin, remdesivir, baricitinib, tocilizumab, sarilumab, lopinavir/ritonavir and oseltamivir; and clinical outcomes including, death and mechanical ventilation.

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 vaccines targeted against SARS-CoV-2, 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.

Recruitment information / eligibility
Status Completed
Enrollment 400
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Centre Hospitalier Intercommunal Robert Ballanger Aulnay-sous-Bois
France Centre Hospitalier Intercommunal Le Raincy-Montfermeil Montfermeil

Sponsors (4)
Lead Sponsor Collaborator
Groupe Hospitalier Pitie-Salpetriere Centre Hospitalier Intercommunal Montfermeil-Le Raincy, Centre Hospitalier Intercommunal Robert Ballanger, CMC Ambroise Paré

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Composite of death and mechanical ventilation Composite of death and mechanical ventilation (i.e. intubation) 14-days follow-up
Secondary Death Death 14-days follow-up
Secondary Mechanical ventilation Enabled by intubation 14-days follow-up
Secondary Composite of death and mechanical ventilation Composite of death and mechanical ventilation 28-days follow-up
Secondary World Health Organization score World Health Organization score 14-days follow-up
Secondary World Health Organization score World Health Organization score 28-days follow-up
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