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OpenTrials
Completed

NCT Number: NCT04365764

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

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.

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Key information

Conditions

COVID-19 ARDS Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Intercommunal Robert Ballanger, Aulnay-sous-Bois, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Composite of death and mechanical ventilation

    Time frame: 14-days follow-up

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

Secondary outcomes

  1. Death

    Time frame: 14-days follow-up

    Death

  2. Mechanical ventilation

    Time frame: 14-days follow-up

    Enabled by intubation

  3. Composite of death and mechanical ventilation

    Time frame: 28-days follow-up

    Composite of death and mechanical ventilation

  4. World Health Organization score

    Time frame: 14-days follow-up

    World Health Organization score

  5. World Health Organization score

    Time frame: 28-days follow-up

    World Health Organization score

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Pitie-Salpetriere

Other

Collaborators

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

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 28, 2020
Registry last updated
Apr 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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