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

October 10, 2024 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
451

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Nantes, France
        • CHU de Nantes
      • Paris, France
        • Hôpital 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 Clínic 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
All Case Mortality by Day 28
Time Frame: Day 28
Occurrence of death within 28 days.
Day 28
Duration of Hopitalisation
Time Frame: Day 28
Number of hospital discharges by day 28.
Day 28

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale
Time Frame: Day 7

Clinical status assessed by a 7-point ordinal scale on Day 7 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 A higher score indicates a better outcome
Day 7
Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14
Time Frame: Day 14

7-point ordinal 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 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
Time Frame: Day 7, 14, and 28

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:

  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 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
Time Frame: 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:

  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 28
SpO2 > 94% on Room Air
Time Frame: Day 28
Number of participants SpO2 > 94% on room air by day 28
Day 28
Duration of Oxygen Therapy
Time Frame: Day 28
Median (IQR) duration on oxygen therapy by day 28.
Day 28
ICU Admission
Time Frame: Day 28
Intensive care unit admission over entire study period
Day 28
Duration of ICU
Time Frame: through study completion, 28 days
Number of days spent in ICU
through study completion, 28 days
Mechanical Ventilation/ECMO Use
Time Frame: Day 28
Use of mechanical ventilation/ECMO (extracorporeal membrane oxygenation) over study period
Day 28
Timing of Remdesivir Exposure
Time Frame: Day 28
Median (IQR) time from first symptoms to use of remdesivir
Day 28
Timing From Hospitalisation to Remdesivir Exposure
Time Frame: Day 28
Median (IQR) time from hospitalisation to use of remdesivir
Day 28
Duration of Remdesivir Use
Time Frame: Day 28
Median (IQR) duration of use of remdesivir
Day 28
Readmission With COVID-19 Complications
Time Frame: Day 28
Re-admission with COVID-19 complications or recurrence within 28 days of discharge and outcome
Day 28

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NEAT ID Foundation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 12, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 17, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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