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

Completed

• Conditions: Pneumonia; Covid-19; ARDS

• Registration Number: NCT04365764
• Lead Sponsor: 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 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.

Study Timeline

• Study Start: 2020-03-14
• Study First Submitted: 2020-04-25
• Study First Submitted QC: 2020-04-25
• Study First Posted: 2020-04-28
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-19
• Last Update Posted: 2023-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite of death and mechanical ventilation	14-days follow-up	Composite of death and mechanical ventilation (i.e. intubation)

Secondary Outcome Measures

Name	Time	Method
Death	14-days follow-up	Death
Mechanical ventilation	14-days follow-up	Enabled by intubation
Composite of death and mechanical ventilation	28-days follow-up	Composite of death and mechanical ventilation
World Health Organization score	28-days follow-up	World Health Organization score

Trial Locations

Locations (2)

Centre Hospitalier Intercommunal Robert Ballanger; 🇫🇷 Aulnay-sous-Bois, France

Centre Hospitalier Intercommunal Le Raincy-Montfermeil; 🇫🇷 Montfermeil, France