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Study to Evaluate the Clinical Outcomes in Adults With Covid-19 Who Have Been Treated With Remdesivir.

NCT ID: NCT04847622

Last Updated: 2024-11-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

451 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-12

Study Completion Date

2021-04-30

Brief Summary

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This is a multi-centre, multi-country retrospective cohort study. At least 450COVID-19 cases from up to 20 participating study sites who meet all eligibility criteria will be included in the analysis. Deidentified data will be extracted from electronic medical record (EMR) databases, clinical registries, case series or additional sources from participating sites and countries, and then entered into a structured e-CRF system. addition, each site/country will be surveyed to determine the local standard of care therapy for COVID-19 infection and to determine if standard protocols were/are in place for the use of Remdesivir and if/how the protocols changed over time.

Detailed Description

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Conditions

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Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Target Population

Adults with COVID-19 diagnosed and treated with Remdesivir after Aug 31st2020.

Remdesivir

Intervention Type DRUG

treated with Remdesivir

Interventions

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Remdesivir

treated with Remdesivir

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

All Adult participants with COVID-19 confirmed by PCR who meet the following criteria:

* Hospitalised after August 31st,2020
* Receivedat least one dose of Remdesivir(RDV)at anytime during hospitalisation

Exclusion Criteria

* Received Remdesivir as part of a clinical trial, compassionate use or expanded access program
* Received Remdesivir prior to this admission at any other health facility than the research sites and whose health records are available.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role collaborator

NEAT ID Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Nantes

Nantes, , France

Site Status

Hospital Lariboisiere

Paris, , France

Site Status

Hopital Saint-Louis

Paris, , France

Site Status

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status

Erasmus Medical Center

Rotterdam, , Netherlands

Site Status

Hospital Germans Trias i Pujol

Barcelona, , Spain

Site Status

Hospital Clínic de Barcelona

Barcelona, , Spain

Site Status

Hospital Universitari Vall d'Herbon

Barcelona, , Spain

Site Status

Hospital Clinico Universitario San Carlos

Madrid, , Spain

Site Status

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status

Royal Free Hospital

London, , United Kingdom

Site Status

Chelsea & Westminster Hospital

London, , United Kingdom

Site Status

Countries

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France Israel Netherlands Spain United Kingdom

References

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Arber N, Shah PL, Assoumou L, Rokx C, De Castro N, Bakhai A, Soriano Viladomiu A, Mateu L, Lumbreras C, Estrada V, Curran A, Sellier PO, Duffy A, Fletcher C, Mozaffari E, Haubrich R, Hodgkins P, Pozniak A, Raffi F. Clinical outcomes by supplemental oxygen use in remdesivir-treated, hospitalised adults with COVID-19. Infect Dis Now. 2023 Oct;53(7):104760. doi: 10.1016/j.idnow.2023.104760. Epub 2023 Jul 14.

Reference Type DERIVED
PMID: 37454762 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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NEAT ID 909REM

Identifier Type: -

Identifier Source: org_study_id