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 Type
OBSERVATIONAL
Enrollment
451
treated with Remdesivir
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 Germans Trias i Pujol
Barcelona, Spain
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital Universitari Vall d'Herbon
Barcelona, Spain
Hospital Clinico Universitario San Carlos
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
...and 2 more locations
All Case Mortality by Day 28
Occurrence of death within 28 days.
Time frame: Day 28
Duration of Hopitalisation
Number of hospital discharges by day 28.
Time frame: Day 28
Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale
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
Time frame: Day 7
Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on 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
Time frame: Day 14
Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score
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.
Time frame: Day 7, 14, and 28
Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on 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
Time frame: Day 28
SpO2 > 94% on Room Air
Number of participants SpO2 \> 94% on room air by day 28
Time frame: Day 28
Duration of Oxygen Therapy
Median (IQR) duration on oxygen therapy by day 28.
Time frame: Day 28
ICU Admission
Intensive care unit admission over entire study period
Time frame: Day 28
Duration of ICU
Number of days spent in ICU
Time frame: through study completion, 28 days
Mechanical Ventilation/ECMO Use
Use of mechanical ventilation/ECMO (extracorporeal membrane oxygenation) over study period
Time frame: Day 28
Timing of Remdesivir Exposure
Median (IQR) time from first symptoms to use of remdesivir
Time frame: Day 28
Timing From Hospitalisation to Remdesivir Exposure
Median (IQR) time from hospitalisation to use of remdesivir
Time frame: Day 28
Duration of Remdesivir Use
Median (IQR) duration of use of remdesivir
Time frame: Day 28
Readmission With COVID-19 Complications
Re-admission with COVID-19 complications or recurrence within 28 days of discharge and outcome
Time frame: Day 28
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