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

Completed

Conditions: Covid19

Interventions: Drug: Remdesivir

Registration Number: NCT04847622

Lead Sponsor: NEAT ID Foundation

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 451

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 & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Target Population	Remdesivir	Adults with COVID-19 diagnosed and treated with Remdesivir after Aug 31st2020.

Primary Outcome Measures

Name	Time	Method
All Case Mortality by Day 28	Day 28	Occurrence of death within 28 days.
Duration of Hopitalisation	Day 28	Number of hospital discharges by day 28.

Secondary Outcome Measures

Name	Time	Method
Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale	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
Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14	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
Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score	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.
Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28	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
SpO2 > 94% on Room Air	Day 28	Number of participants SpO2 \> 94% on room air by day 28
Duration of Oxygen Therapy	Day 28	Median (IQR) duration on oxygen therapy by day 28.
ICU Admission	Day 28	Intensive care unit admission over entire study period
Duration of ICU	through study completion, 28 days	Number of days spent in ICU
Mechanical Ventilation/ECMO Use	Day 28	Use of mechanical ventilation/ECMO (extracorporeal membrane oxygenation) over study period
Timing of Remdesivir Exposure	Day 28	Median (IQR) time from first symptoms to use of remdesivir
Timing From Hospitalisation to Remdesivir Exposure	Day 28	Median (IQR) time from hospitalisation to use of remdesivir
Duration of Remdesivir Use	Day 28	Median (IQR) duration of use of remdesivir
Readmission With COVID-19 Complications	Day 28	Re-admission with COVID-19 complications or recurrence within 28 days of discharge and outcome

Trial Locations

Locations (12): CHU de Nantes
🇫🇷
Nantes, France
Hospital Lariboisiere
🇫🇷
Paris, France
Hopital Saint-Louis
🇫🇷
Paris, France
Tel Aviv Sourasky Medical Center
🇮🇱
Tel Aviv, Israel
Erasmus Medical Center
🇳🇱
Rotterdam, Netherlands
Hospital Clínic de Barcelona
🇪🇸
Barcelona, Spain
Hospital Universitari Vall d'Herbon
🇪🇸
Barcelona, Spain
Hospital Clinico Universitario San Carlos
🇪🇸
Madrid, Spain
Hospital Germans Trias i Pujol
🇪🇸
Barcelona, Spain
Hospital Universitario 12 de Octubre
🇪🇸
Madrid, Spain
Royal Free Hospital
🇬🇧
London, United Kingdom
Chelsea & Westminster Hospital
🇬🇧
London, United Kingdom