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

NCT04847622 | Completed Results FDA Drug

• 1 other identifier: NEAT ID 909REM
• Study Type: observational
• Target: 451
• Locations: 5 countries
• Sites: 12

Brief Summary

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (2)

• All Case Mortality by Day 28

  Occurrence of death within 28 days.

  Day 28

• Duration of Hopitalisation

  Number of hospital discharges by day 28.

  Day 28

Secondary Outcomes (13)

• Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale

  Day 7

• Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14

  Day 14

• Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score

  Day 7, 14, and 28

• Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28

  Day 28

• SpO2 > 94% on Room Air

  Day 28

Study Arms (1)

Target Population

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

Drug: Remdesivir

Interventions

Remdesivir DRUG

treated with Remdesivir

Target Population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NEAT ID Foundation: lead
• Gilead Sciences: collaborator

Study Sites (12)

CHU de Nantes

Nantes, France

Location

Hospital Lariboisiere

Paris, 75010, France

Location

Hopital Saint-Louis

Paris, France

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

Erasmus Medical Center

Rotterdam, 3015, Netherlands

Location

Hospital Germans Trias i Pujol

Barcelona, 08916, Spain

Location

Hospital Clínic de Barcelona

Barcelona, Spain

Location

Hospital Universitari Vall d'Herbon

Barcelona, Spain

Location

Hospital Clinico Universitario San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

Chelsea & Westminster Hospital

London, SW10 9NH, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 37454762 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

remdesivir

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Toni Sobande, Clinical Project Manager
• Organization: Research Organisation King's Cross (KC) Ltd.

toni.sobande@rokcservices.com

447494 795 982

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: April 19, 2021
• Study Start: February 12, 2021
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: November 29, 2024
• Results First Posted: November 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5); GB (2); NL (1); FR (3); IL (1)