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Completed

NCT Number: NCT04847622

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nantes, Nantes, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remdesivir

Drug

treated with Remdesivir

Primary outcomes

  1. All Case Mortality by Day 28

    Time frame: Day 28

    Occurrence of death within 28 days.

  2. Duration of Hopitalisation

    Time frame: Day 28

    Number of hospital discharges by day 28.

Secondary outcomes

  1. 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:

    • 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

  2. Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14

    Time frame: 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

  3. 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:

    • 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.

  4. 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:

    • 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

  5. SpO2 > 94% on Room Air

    Time frame: Day 28

    Number of participants SpO2 > 94% on room air by day 28

  6. Duration of Oxygen Therapy

    Time frame: Day 28

    Median (IQR) duration on oxygen therapy by day 28.

  7. ICU Admission

    Time frame: Day 28

    Intensive care unit admission over entire study period

  8. Duration of ICU

    Time frame: through study completion, 28 days

    Number of days spent in ICU

  9. Mechanical Ventilation/ECMO Use

    Time frame: Day 28

    Use of mechanical ventilation/ECMO (extracorporeal membrane oxygenation) over study period

  10. Timing of Remdesivir Exposure

    Time frame: Day 28

    Median (IQR) time from first symptoms to use of remdesivir

  11. Timing From Hospitalisation to Remdesivir Exposure

    Time frame: Day 28

    Median (IQR) time from hospitalisation to use of remdesivir

  12. Duration of Remdesivir Use

    Time frame: Day 28

    Median (IQR) duration of use of remdesivir

  13. Readmission With COVID-19 Complications

    Time frame: Day 28

    Re-admission with COVID-19 complications or recurrence within 28 days of discharge and outcome

Sponsors and collaborators

Lead sponsor

NEAT ID Foundation

Other

Collaborators

  • Gilead Sciences

Registry information

Official study 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.

Acronym: 909REM

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 19, 2021
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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