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Clinical Trials/NCT04365764
NCT04365764
Completed
Not Applicable

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

Groupe Hospitalier Pitie-Salpetriere2 sites in 1 country400 target enrollmentMarch 14, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Covid-19
Sponsor
Groupe Hospitalier Pitie-Salpetriere
Enrollment
400
Locations
2
Primary Endpoint
Composite of death and mechanical ventilation
Status
Completed
Last Updated
3 years ago

Overview

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

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 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.

Registry
clinicaltrials.gov
Start Date
March 14, 2020
End Date
December 31, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Groupe Hospitalier Pitie-Salpetriere
Responsible Party
Principal Investigator
Principal Investigator

Lee S Nguyen

Study coordinator

Groupe Hospitalier Pitie-Salpetriere

Eligibility 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

Outcomes

Primary Outcomes

Composite of death and mechanical ventilation

Time Frame: 14-days follow-up

Composite of death and mechanical ventilation (i.e. intubation)

Secondary Outcomes

  • Mechanical ventilation(14-days follow-up)
  • Composite of death and mechanical ventilation(28-days follow-up)
  • World Health Organization score(28-days follow-up)
  • Death(14-days follow-up)

Study Sites (2)

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