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

Sponsor

NEAT ID Foundation (Other)

Overall Status

Recruiting

CT.gov ID

NCT04847622

Collaborator

Gilead Sciences (Industry)

450

Enrollment

Locations

4.9

Anticipated Duration (Months)

37.5

Patients Per Site

7.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Drug: Remdesivir

Study Design

Study Type:

Observational

Anticipated Enrollment :

450 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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.

Actual Study Start Date :

Feb 1, 2021

Anticipated Primary Completion Date :

Jun 30, 2021

Anticipated Study Completion Date :

Jun 30, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Target Population

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

Drug: Remdesivir

treated with Remdesivir

Outcome Measures

Primary Outcome Measures

All-cause mortality [Day 28]
All-cause mortality
Clinical status assessed by a 7-point ordinal scale [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

Secondary Outcome Measures

Proportion of clinical improvement. [Day 14]
Proportion of clinical improvement at Day 14, defined as a ≥ 2-point improvement from Day 1 on a 7-point ordinal scale
Severity of disease [Day 28]
Severity of disease on Day 7, Day 14 and Day 28 based on NEWS 2 score
Clinical status assessed by a 7-point ordinal scale [Day 28]
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.
Time to SpO2 [Day 28]
Time to SpO2 > 94% on room air (number of days when evaluation made on day 7, 14 or 28)
Duration of oxygen therapy [through study completion, an average of 1 month]
Duration of oxygen therapy (total days)
Admission to the Intensive Care Unit [through study completion, an average of 1 month]
Admission of a subject to the Intensive Care Unit
Time on mechanical ventilation/ECMO [through study completion, an average of 1 month]
Need for and time on mechanical ventilation/ECMO of hospitalisation
Duration of hospitalisation [through study completion, an average of 1 month]
Duration of hospitalisation in days

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CHU de Nantes	Nantes	France
2	Hospital Lariboisiere	Paris	France	75010
3	Hopital Saint-Louis	Paris	France
4	Tel Aviv Sourasky Medical Center	Tel Aviv	Israel
5	Erasmus Medical Center	Rotterdam	Netherlands	3015
6	Hospital Germans Trias i Pujol	Barcelona	Spain	08916
7	Hospital Clínic de Barcelona	Barcelona	Spain
8	Hospital Universitari Vall d'Herbon	Barcelona	Spain
9	Hospital Clinico Universitario San Carlos	Madrid	Spain	28040
10	Hospital Universitario 12 de Octubre	Madrid	Spain	28041
11	Royal Free Hospital	London	United Kingdom	NW3 2QG
12	Chelsea & Westminster Hospital	London	United Kingdom	SW10 9NH

Sponsors and Collaborators

NEAT ID Foundation
Gilead Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NEAT ID Foundation

ClinicalTrials.gov Identifier:

NCT04847622

Other Study ID Numbers:

NEAT ID 909REM

First Posted:

Apr 19, 2021

Last Update Posted:

Apr 19, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

COVID-19

Remdesivir

Study Results

No Results Posted as of Apr 19, 2021