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

NCT ID: NCT04365764

Last Updated: 2023-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-14

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Covid-19 ARDS Pneumonia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Exposed to the treatment

Exposure variable will be studied treatment

No interventions assigned to this group

Not exposer to the treatment (control group)

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Intercommunal Robert Ballanger

OTHER

Sponsor Role collaborator

Centre Hospitalier Intercommunal Montfermeil-Le Raincy

UNKNOWN

Sponsor Role collaborator

CMC Ambroise Paré

OTHER

Sponsor Role collaborator

Groupe Hospitalier Pitie-Salpetriere

OTHER

Sponsor Role lead

Responsible Party

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Lee S Nguyen

Study coordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joe-Elie Salem, MD, PhD

Role: STUDY_CHAIR

APHP

Locations

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Centre Hospitalier Intercommunal Robert Ballanger

Aulnay-sous-Bois, , France

Site Status

Centre Hospitalier Intercommunal Le Raincy-Montfermeil

Montfermeil, , France

Site Status

Countries

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France

Other Identifiers

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CIC1421-20-06

Identifier Type: -

Identifier Source: org_study_id

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