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

Covid19 Clinical Trial

— 909REM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04847622
• Other study ID #: NEAT ID 909REM
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: June 30, 2021

Study information

• Verified date: April 2021
• Source: NEAT ID Foundation
• Contact: Anton Pozniak
• Phone: 00442087465620
• Email: anton.pozniak[@]chelwest.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid19

Intervention

Drug:
• Remdesivir
treated with Remdesivir

Locations

Country	Name	City	State
France	CHU de Nantes	Nantes
France	Hopital Saint-Louis	Paris
France	Hospital Lariboisiere	Paris
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Netherlands	Erasmus Medical Center	Rotterdam
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital Germans Trias i Pujol	Barcelona
Spain	Hospital Universitari Vall d'Herbon	Barcelona
Spain	Hospital Clinico Universitario San Carlos	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
United Kingdom	Chelsea & Westminster Hospital	London
United Kingdom	Royal Free Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
NEAT ID Foundation	Gilead Sciences

Countries where clinical trial is conducted

France,  Israel,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality	All-cause mortality	Day 28
Primary	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	Day 14
Secondary	Proportion of clinical improvement.	Proportion of clinical improvement at Day 14, defined as a = 2-point improvement from Day 1 on a 7-point ordinal scale	Day 14
Secondary	Severity of disease	Severity of disease on Day 7, Day 14 and Day 28 based on NEWS 2 score	Day 28
Secondary	Clinical status assessed by a 7-point ordinal scale	Clinical status assessed by a 7-point ordinal scale on Day 28 (or at last observation if discharged or died prior to this time point) in those still Hospitalised after day 14.	Day 28
Secondary	Time to SpO2	Time to SpO2 > 94% on room air (number of days when evaluation made on day 7, 14 or 28)	Day 28
Secondary	Duration of oxygen therapy	Duration of oxygen therapy (total days)	through study completion, an average of 1 month
Secondary	Admission to the Intensive Care Unit	Admission of a subject to the Intensive Care Unit	through study completion, an average of 1 month
Secondary	Time on mechanical ventilation/ECMO	Need for and time on mechanical ventilation/ECMO of hospitalisation	through study completion, an average of 1 month
Secondary	Duration of hospitalisation	Duration of hospitalisation in days	through study completion, an average of 1 month