Study to Evaluate the Clinical Outcomes in Adults With Covid-19 Who Have Been Treated With Remdesivir. (909REM)

A Multi-centre, Multi-country Retrospective Cohort Study to Evaluate the Clinical Outcomes in Adults With Covid-19 Who Have Been Treated With Remdesivir.

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Drug: Remdesivir

• Study Type: Observational
• Enrollment (Actual): 451

Contacts and Locations

Study Locations

• France
  • Nantes, France
    • Chu de Nantes
  • Paris, France
    • Hopital Saint-Louis
  • Paris, France, 75010
    • Hospital Lariboisière
• Israel
  • Tel Aviv, Israel
    • Tel Aviv Sourasky Medical Center
• Netherlands
  • Rotterdam, Netherlands, 3015
    • Erasmus Medical Center
• Spain
  • Barcelona, Spain
    • Hospital Clinic de Barcelona
  • Barcelona, Spain, 08916
    • Hospital Germans Trias i Pujol
  • Barcelona, Spain
    • Hospital Universitari Vall d'Herbon
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28040
    • Hospital Clinico Universitario San Carlos
• United Kingdom
  • London, United Kingdom, NW3 2QG
    • Royal Free Hospital
  • London, United Kingdom, SW10 9NH
    • Chelsea & Westminster Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Target Population; Adults with COVID-19 diagnosed and treated with Remdesivir after Aug 31st2020.	Drug: Remdesivir; treated with Remdesivir

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale	Clinical status assessed by a 7-point ordinal scale on Day 7 7-point ordinary scale: Death; Hospitalised, on invasive mechanical ventilation or ECMO; Hospitalised, on non-invasive ventilation or high flow oxygen devices; Hospitalised, requiring low flow supplemental oxygen; Hospitalised, not requiring supplemental oxygen -requiring ongoing medical care (COVID-19 related or otherwise); Hospitalised, not requiring supplemental oxygen -no longer requires ongoing medical care; Not hospitalised A higher score indicates a better outcome	Day 7
Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14	7-point ordinal scale: Death; Hospitalised, on invasive mechanical ventilation or ECMO; Hospitalised, on non-invasive ventilation or high flow oxygen devices; Hospitalised, requiring low flow supplemental oxygen; Hospitalised, not requiring supplemental oxygen -requiring ongoing medical care (COVID-19 related or otherwise); Hospitalised, not requiring supplemental oxygen -no longer requires ongoing medical care; Not hospitalised A higher score indicates a better outcome	Day 14
Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score	NEWS2 is a summary score of six physiological parameters (respiratory rate, oxygen saturation, systolic blood pressure, heart rate, consciousness, temperature, and supplemental oxygen dependency). The parameters are assessed to generate a severity score classified as low: aggregate score 0-4, low - medium/medium: score of 3 in any individual parameter/aggregate score 5-6,high: aggregate score 7 or more. A higher score indicates a greater clinical risk. Clinical status assessed by a 7-point ordinal scale.7-point ordinary scale: Death; Hospitalised,on invasive mechanical ventilation or ECMO; Hospitalised,on non-invasive ventilation or high flow oxygen devices; Hospitalised,requiring low flow supplemental oxygen; Hospitalised,not requiring supplemental oxygen -requiring ongoing medical care (COVID-19 related or otherwise); Hospitalised,not requiring supplemental oxygen -no longer requires ongoing medical care; Not hospitalised A higher score indicates a better outcome.	Day 7, 14, and 28
Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28	Clinical status assessed by a 7-point ordinal clinical status scale on Day 28 (or at last observation if discharged or died prior to this time point) in those still hospitalised after Day 14 7-point ordinary scale: Death; Hospitalised, on invasive mechanical ventilation or ECMO; Hospitalised, on non-invasive ventilation or high flow oxygen devices; Hospitalised, requiring low flow supplemental oxygen; Hospitalised, not requiring supplemental oxygen -requiring ongoing medical care (COVID-19 related or otherwise); Hospitalised, not requiring supplemental oxygen -no longer requires ongoing medical care; Not hospitalised	Day 28
SpO2 > 94% on Room Air	Number of participants SpO2 > 94% on room air by day 28	Day 28
Duration of Oxygen Therapy	Median (IQR) duration on oxygen therapy by day 28.	Day 28
ICU Admission	Intensive care unit admission over entire study period	Day 28
Duration of ICU	Number of days spent in ICU	through study completion, 28 days
Mechanical Ventilation/ECMO Use	Use of mechanical ventilation/ECMO (extracorporeal membrane oxygenation) over study period	Day 28
Timing of Remdesivir Exposure	Median (IQR) time from first symptoms to use of remdesivir	Day 28
Timing From Hospitalisation to Remdesivir Exposure	Median (IQR) time from hospitalisation to use of remdesivir	Day 28
Duration of Remdesivir Use	Median (IQR) duration of use of remdesivir	Day 28
Readmission With COVID-19 Complications	Re-admission with COVID-19 complications or recurrence within 28 days of discharge and outcome	Day 28

Collaborators and Investigators

• Sponsor: NEAT ID Foundation
• Collaborators: Gilead Sciences

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2021
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: April 14, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2024
• Last Update Submitted That Met QC Criteria: October 10, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Antiviral Agents; Remdesivir
• Other Study ID Numbers: NEAT ID 909REM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No