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

• Remdesivir (Drug): treated with Remdesivir

Primary outcomes

• 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 outcomes

• 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

Sex: All, ages: 18 Years to any

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.

Participant flow

Outcome results

• All Case Mortality by Day 28 (Primary), Number, participants: Overall 52; Low Disease Severity at Baseline 5; Medium Disease Severity at Baseline 30; High Disease Severity at Baseline 17
• Duration of Hopitalisation (Primary), Number, participants: Overall 369; Low Disease Severity at Baseline 69; Medium Disease Severity at Baseline 248; High Disease Severity at Baseline 52
• Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale (Secondary), Count of participants, Participants: Overall 10; Low Disease Severity at Baseline 2; Medium Disease Severity at Baseline 3; High Disease Severity at Baseline 5
• Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14 (Secondary), Count of participants, Participants: Overall 36; Low Disease Severity at Baseline 5; Medium Disease Severity at Baseline 17; High Disease Severity at Baseline 14
• Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score (Secondary), Count of participants, Participants: Low Severity 2; Low - Medium/ Medium Severity 3; High Severity 4; Overall 9
• Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28 (Secondary), Count of participants, Participants: Overall 52; Low Disease Severity at Baseline 5; Medium Disease Severity at Baseline 30; High Disease Severity at Baseline 17
• SpO2 > 94% on Room Air (Secondary), Count of participants, Participants: Overall 154; Low Disease Severity at Baseline 22; Medium Disease Severity at Baseline 113; High Disease Severity at Baseline 19
• Duration of Oxygen Therapy (Secondary), Median, days: Overall 6 (4 to 9); Low Disease Severity at Baseline 5 (3 to 8); Medium Disease Severity at Baseline 6 (4 to 9); High Disease Severity at Baseline 6 (4 to 12)
• ICU Admission (Secondary), Number, participants: Overall 55; Low Disease Severity at Baseline 3; Medium Disease Severity at Baseline 33; High Disease Severity at Baseline 19
• Duration of ICU (Secondary), Median, days: Overall 13 (8 to 19); Low Disease Severity at Baseline 10 (7 to 11); Medium Disease Severity at Baseline 17 (10 to 17); High Disease Severity at Baseline 10 (6 to 16)
• Mechanical Ventilation/ECMO Use (Secondary), Number, participants: Overall 25; Low Disease Severity at Baseline 3; Medium Disease Severity at Baseline 17; High Disease Severity at Baseline 5
• Timing of Remdesivir Exposure (Secondary), Median, days: Overall 7 (4 to 9); Low Disease Severity at Baseline 7 (4 to 11); Medium Disease Severity at Baseline 7 (4 to 9); High Disease Severity at Baseline 7 (5 to 9)
• Timing From Hospitalisation to Remdesivir Exposure (Secondary), Median, days: Overall 1 (0 to 2); Low Disease Severity at Baseline 2 (1 to 3); Medium Disease Severity at Baseline 1 (0 to 2); High Disease Severity at Baseline 1 (0 to 1)
• Duration of Remdesivir Use (Secondary), Median, days: Overall 5 (4 to 5); Low Disease Severity at Baseline 5 (4 to 6); Medium Disease Severity at Baseline 5 (4 to 5); High Disease Severity at Baseline 5 (3 to 6)
• Readmission With COVID-19 Complications (Secondary), Count of participants, Participants: Overall 16; Low Disease Severity at Baseline 3; Medium Disease Severity at Baseline 11; High Disease Severity at Baseline 2

Adverse events

Time frame: Day 28

Serious adverse events by term

• Results publication: Arber N, Shah PL, Assoumou L, Rokx C, De Castro N, Bakhai A, Soriano Viladomiu A, Mateu L, Lumbreras C, Estrada V, Curran A, Sellier PO, Duffy A, Fletcher C, Mozaffari E, Haubrich R, Hodgkins P, Pozniak A, Raffi F. Clinical outcomes by supplemental oxygen use in remdesivir-treated, hospitalised adults with COVID-19. Infect Dis Now. 2023 Oct;53(7):104760. doi: 10.1016/j.idnow.2023.104760. Epub 2023 Jul 14. PMID 37454762

• Study Protocol (PDF, 2020-12-17)
• Statistical Analysis Plan (PDF, 2021-05-07)