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

April 19, 2023 updated by: Lee S Nguyen, Groupe Hospitalier Pitie-Salpetriere
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aulnay-sous-Bois, France
        • Centre Hospitalier Intercommunal Robert Ballanger
      • Montfermeil, France
        • Centre Hospitalier Intercommunal Le Raincy-Montfermeil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population is cohort-base in routine care, in medical departments.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of death and mechanical ventilation
Time Frame: 14-days follow-up
Composite of death and mechanical ventilation (i.e. intubation)
14-days follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: 14-days follow-up
Death
14-days follow-up
Mechanical ventilation
Time Frame: 14-days follow-up
Enabled by intubation
14-days follow-up
Composite of death and mechanical ventilation
Time Frame: 28-days follow-up
Composite of death and mechanical ventilation
28-days follow-up
World Health Organization score
Time Frame: 14-days follow-up
World Health Organization score
14-days follow-up
World Health Organization score
Time Frame: 28-days follow-up
World Health Organization score
28-days follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Pitie-Salpetriere

Collaborators

CMC Ambroise Paré
Centre Hospitalier Intercommunal Robert Ballanger
Centre Hospitalier Intercommunal Montfermeil-Le Raincy

Investigators

  • Study Chair: Joe-Elie Salem, MD, PhD, APHP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2020

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

April 25, 2020

First Submitted That Met QC Criteria

April 25, 2020

First Posted (Actual)

April 28, 2020

Study Record Updates

Last Update Posted (Actual)

April 21, 2023

Last Update Submitted That Met QC Criteria

April 19, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIC1421-20-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

IPD may be available on request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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