NCT04365764

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 14, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 25, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 28, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

April 21, 2023

Status Verified

April 1, 2023

Enrollment Period

2.8 years

First QC Date

April 25, 2020

Last Update Submit

April 19, 2023

Conditions

Covid-19ARDSPneumonia

Outcome Measures

Primary Outcomes (1)

  • Composite of death and mechanical ventilation

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

    14-days follow-up

Secondary Outcomes (5)

  • Death

    14-days follow-up

  • Mechanical ventilation

    14-days follow-up

  • Composite of death and mechanical ventilation

    28-days follow-up

  • World Health Organization score

    14-days follow-up

  • World Health Organization score

    28-days follow-up

Study Arms (2)

Exposed to the treatment

Exposure variable will be studied treatment

Not exposer to the treatment (control group)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • admitted for severe Covid-19 pneumonia (i.e. requiring O2-support more than 6L/min with SpO2\<96%)

You may not qualify if:

  • patients who were previously in ICU
  • patients already hospitalized prior to study start date
  • patients in palliative care
  • lack of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier Intercommunal Robert Ballanger

Aulnay-sous-Bois, France

Location

Centre Hospitalier Intercommunal Le Raincy-Montfermeil

Montfermeil, France

Location

MeSH Terms

Conditions

COVID-19Pneumonia

Condition Hierarchy (Ancestors)

Pneumonia, ViralRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Joe-Elie Salem, MD, PhD

    APHP

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study coordinator

Study Record Dates

First Submitted

April 25, 2020

First Posted

April 28, 2020

Study Start

March 14, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

April 21, 2023

Record last verified: 2023-04

Locations

FR(2)