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

April 14, 2021 updated by: NEAT ID Foundation

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Nantes, France
      • Paris, France, 75010
      • Paris, France
        • Recruiting
        • Hopital Saint-Louis
        • Contact:
        • Principal Investigator:
          • Jean-Michael Molina, Dr
  • Israel
      • Tel Aviv, Israel
  • Netherlands
      • Rotterdam, Netherlands, 3015
  • Spain
      • Barcelona, Spain, 08916
      • Barcelona, Spain
        • Recruiting
        • Hospital Clinic de Barcelona
        • Contact:
        • Principal Investigator:
          • Alex Soriano, Dr
      • Barcelona, Spain
        • Recruiting
        • Hospital Universitari Vall d'Herbon
        • Principal Investigator:
          • Adrian Curran
        • Contact:
      • Madrid, Spain, 28041
      • Madrid, Spain, 28040
  • United Kingdom
      • London, United Kingdom, NW3 2QG
        • Recruiting
        • Royal Free Hospital
        • Contact:
        • Principal Investigator:
          • Ameet Bakhai, Dr
      • London, United Kingdom, SW10 9NH
        • Recruiting
        • Chelsea & Westminster Hospital
        • Contact:
        • Principal Investigator:
          • Pallav Shah, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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-cause mortality
Time Frame: Day 28
All-cause mortality
Day 28
Clinical status assessed by a 7-point ordinal scale
Time Frame: Day 14

7-point ordinary scale:

  1. Death
  2. Hospitalised, on invasive mechanical ventilation or ECMO
  3. Hospitalised, on non-invasive ventilation or high flow oxygen devices
  4. Hospitalised, requiring low flow supplemental oxygen
  5. Hospitalised, not requiring supplemental oxygen -requiring ongoing medical care (COVID-19 related or otherwise)
  6. Hospitalised, not requiring supplemental oxygen -no longer requires ongoing medical care
  7. Not hospitalised
Day 14

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NEAT ID Foundation

Collaborators

Gilead Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Anticipated)

June 30, 2021

Study Completion (Anticipated)

June 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)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 14, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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