Covid19
Conditions
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.
Interventions
DRUGRemdesivir
treated with Remdesivir
Sponsors
Gilead Sciences
NEAT ID Foundation
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Duration of ICU | through study completion, 28 days | Number of days spent in ICU |
| 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 |
Countries
France, Israel, Netherlands, Spain, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cases Adults with COVID-19 diagnosed and treated with Remdesivir after Aug 31st, 2020.
1. Hospitalised after August 31st,2020
2. Received at least one dose of Remdesivir (RDV) at any time during hospitalisation | 448 |
| Total | 448 |
Baseline characteristics
| Characteristic | Cases |
|---|---|
| Age, Continuous | 65 Years |
| Body mass index (BMI, Kg/m²) | 28.4 Kg/m² |
| Comorbidities Asthma | 33 Participants |
| Comorbidities Cardiovascular Disease excluding Hypertension | 115 Participants |
| Comorbidities Chemo/radiotherapy for cancer | 46 Participants |
| Comorbidities Comorbidities | 355 Participants |
| Comorbidities COPD | 29 Participants |
| Comorbidities Dementia | 15 Participants |
| Comorbidities Diabetes | 138 Participants |
| Comorbidities HIV Infection | 2 Participants |
| Comorbidities Hypertension | 202 Participants |
| Comorbidities Liver Disease | 9 Participants |
| Comorbidities Obesity | 74 Participants |
| Comorbidities Receiving Immuno-Suppressive Agent (Not for Cancer) | 19 Participants |
| Comorbidities Severe renal disease | 16 Participants |
| NEWS2 score High | 100 Participants |
| NEWS2 score Low | 145 Participants |
| NEWS2 score Low-medium/Medium | 146 Participants |
| Other Treatment for COVID-19, n (%) Corticosteroids | 285 Participants |
| Other Treatment for COVID-19, n (%) None | 100 Participants |
| Other Treatment for COVID-19, n (%) Other COVID Treatment Related Drug | 45 Participants |
| Other Treatment for COVID-19, n (%) Tocilizimab /Sarilumab | 18 Participants |
| Pregnant women, n (%) | 0 Participants |
| Race/Ethnicity, Customized Asian | 23 Participants |
| Race/Ethnicity, Customized Black | 12 Participants |
| Race/Ethnicity, Customized Other | 230 Participants |
| Race/Ethnicity, Customized White Caucasian | 159 Participants |
| Race/Ethnicity, Customized White Mixed | 24 Participants |
| Sex: Female, Male Female | 162 Participants |
| Sex: Female, Male Male | 286 Participants |
| SpO2 (%) High disease severity - High flow oxygen | 72 Participants |
| SpO2 (%) Low disease severity - No supplemental oxygen | 81 Participants |
| SpO2 (%) Medium disease severity - Low flow oxygen | 295 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 52 / 448 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 52 / 448 |
Outcome results
Primary
All Case Mortality by Day 28
Occurrence of death within 28 days.
Time frame: Day 28
Population: Full population analysis - All enrolled participants who met the eligibility criteria and with data available at baseline will be included in the Full Analysis Population. Disease severity was grouped based on oxygen support requirement at baseline: no supple-mental oxygen (NSO), LFO(≤6 litres (l)/minute), and HFO (\>6 l/ minute).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall | All Case Mortality by Day 28 | 52 participants |
| Low Disease Severity at Baseline | All Case Mortality by Day 28 | 5 participants |
| Medium Disease Severity at Baseline | All Case Mortality by Day 28 | 30 participants |
| High Disease Severity at Baseline | All Case Mortality by Day 28 | 17 participants |
Primary
Duration of Hopitalisation
Number of hospital discharges by day 28.
Time frame: Day 28
Population: Full population analysis - All enrolled participants who met the eligibility criteria and with data available at baseline will be included in the Full Analysis Population. Disease severity was grouped based on oxygen support requirement at baseline: no supple-mental oxygen (NSO), LFO(≤6 litres (l)/minute), and HFO (\>6 l/ minute).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall | Duration of Hopitalisation | 369 participants |
| Low Disease Severity at Baseline | Duration of Hopitalisation | 69 participants |
| Medium Disease Severity at Baseline | Duration of Hopitalisation | 248 participants |
| High Disease Severity at Baseline | Duration of Hopitalisation | 52 participants |
Secondary
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
Population: Of the total of 448 hospitalised adult COVID-19 patients who received at least one dose of remdesivir, these 391 (87%) had sufficient baseline data recorded to enable a NEWS2 score to be calculated and were thus included in this analsis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Overall | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 6 at day 14 | 28 Participants |
| Overall | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 4 at day 7 | 45 Participants |
| Overall | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 3 at day 28 | 2 Participants |
| Overall | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 1 at day 7 | 2 Participants |
| Overall | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 7 at day 14 | 68 Participants |
| Overall | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 7 at day 28 | 112 Participants |
| Overall | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 3 at day 14 | 7 Participants |
| Overall | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 2 at day 28 | 0 Participants |
| Overall | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 1 at day 28 | 14 Participants |
| Overall | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 3 at day 7 | 26 Participants |
| Overall | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 5 at day 7 | 25 Participants |
| Overall | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 1 at day 14 | 12 Participants |
| Overall | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 4 at day 14 | 15 Participants |
| Overall | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 6 at day 28 | 11 Participants |
| Overall | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 6 at day 7 | 27 Participants |
| Overall | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 2 at day 7 | 3 Participants |
| Overall | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 5 at day 28 | 3 Participants |
| Overall | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 2 at day 14 | 2 Participants |
| Overall | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 7 at day 7 | 17 Participants |
| Overall | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 5 at day 14 | 13 Participants |
| Overall | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 4 at day 28 | 3 Participants |
| Low Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 4 at day 7 | 46 Participants |
| Low Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 3 at day 7 | 26 Participants |
| Low Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 5 at day 14 | 7 Participants |
| Low Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 5 at day 7 | 16 Participants |
| Low Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 6 at day 7 | 20 Participants |
| Low Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 7 at day 7 | 31 Participants |
| Low Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 6 at day 14 | 32 Participants |
| Low Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 2 at day 14 | 8 Participants |
| Low Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 7 at day 14 | 71 Participants |
| Low Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 1 at day 28 | 14 Participants |
| Low Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 1 at day 14 | 8 Participants |
| Low Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 2 at day 28 | 3 Participants |
| Low Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 3 at day 28 | 1 Participants |
| Low Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 3 at day 14 | 6 Participants |
| Low Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 4 at day 28 | 6 Participants |
| Low Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 5 at day 28 | 3 Participants |
| Low Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 6 at day 28 | 9 Participants |
| Low Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 7 at day 28 | 110 Participants |
| Low Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 4 at day 14 | 14 Participants |
| Low Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 1 at day 7 | 3 Participants |
| Low Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 2 at day 7 | 4 Participants |
| Medium Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 4 at day 14 | 10 Participants |
| Medium Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 4 at day 28 | 3 Participants |
| Medium Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 3 at day 14 | 6 Participants |
| Medium Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 6 at day 7 | 12 Participants |
| Medium Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 2 at day 7 | 4 Participants |
| Medium Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 5 at day 28 | 1 Participants |
| Medium Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 1 at day 14 | 13 Participants |
| Medium Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 5 at day 14 | 5 Participants |
| Medium Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 3 at day 7 | 24 Participants |
| Medium Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 6 at day 28 | 7 Participants |
| Medium Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 1 at day 28 | 19 Participants |
| Medium Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 5 at day 7 | 14 Participants |
| Medium Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 2 at day 14 | 3 Participants |
| Medium Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 4 at day 7 | 28 Participants |
| Medium Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 2 at day 28 | 1 Participants |
| Medium Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 7 at day 14 | 42 Participants |
| Medium Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 6 at day 14 | 21 Participants |
| Medium Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 1 at day 7 | 4 Participants |
| Medium Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 3 at day 28 | 2 Participants |
| Medium Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 7 at day 28 | 67 Participants |
| Medium Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 7 at day 7 | 14 Participants |
| High Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 6 at day 28 | 27 Participants |
| High Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 1 at day 14 | 33 Participants |
| High Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 2 at day 14 | 13 Participants |
| High Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 3 at day 14 | 19 Participants |
| High Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 4 at day 14 | 39 Participants |
| High Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 5 at day 14 | 25 Participants |
| High Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 6 at day 14 | 81 Participants |
| High Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 7 at day 14 | 181 Participants |
| High Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 1 at day 28 | 47 Participants |
| High Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 2 at day 28 | 4 Participants |
| High Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 3 at day 28 | 5 Participants |
| High Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 4 at day 28 | 12 Participants |
| High Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 5 at day 28 | 7 Participants |
| High Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 7 at day 7 | 62 Participants |
| High Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 7 at day 28 | 289 Participants |
| High Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 1 at day 7 | 9 Participants |
| High Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 2 at day 7 | 11 Participants |
| High Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 3 at day 7 | 76 Participants |
| High Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 4 at day 7 | 119 Participants |
| High Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 5 at day 7 | 55 Participants |
| High Disease Severity at Baseline | Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score | Ordinal Scale 6 at day 7 | 59 Participants |
Secondary
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
Population: Hospitalised adult patients with COVID-19 who received at least one dose of remdesivir during their hospital admission.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Overall | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale | Ordinal Scale 1 | 10 Participants |
| Overall | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale | Ordinal Scale 6 | 67 Participants |
| Overall | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale | Ordinal Scale 5 | 70 Participants |
| Overall | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale | Ordinal Scale 2 | 13 Participants |
| Overall | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale | Ordinal Scale 7 | 68 Participants |
| Overall | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale | Ordinal Scale 3 | 80 Participants |
| Overall | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale | Ordinal Scale 4 | 137 Participants |
| Low Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale | Ordinal Scale 6 | 15 Participants |
| Low Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale | Ordinal Scale 4 | 28 Participants |
| Low Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale | Ordinal Scale 3 | 6 Participants |
| Low Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale | Ordinal Scale 5 | 16 Participants |
| Low Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale | Ordinal Scale 7 | 13 Participants |
| Low Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale | Ordinal Scale 2 | 1 Participants |
| Low Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale | Ordinal Scale 1 | 2 Participants |
| Medium Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale | Ordinal Scale 4 | 98 Participants |
| Medium Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale | Ordinal Scale 1 | 3 Participants |
| Medium Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale | Ordinal Scale 2 | 8 Participants |
| Medium Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale | Ordinal Scale 3 | 45 Participants |
| Medium Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale | Ordinal Scale 5 | 47 Participants |
| Medium Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale | Ordinal Scale 6 | 44 Participants |
| Medium Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale | Ordinal Scale 7 | 47 Participants |
| High Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale | Ordinal Scale 3 | 29 Participants |
| High Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale | Ordinal Scale 7 | 8 Participants |
| High Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale | Ordinal Scale 6 | 8 Participants |
| High Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale | Ordinal Scale 2 | 4 Participants |
| High Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale | Ordinal Scale 1 | 5 Participants |
| High Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale | Ordinal Scale 5 | 7 Participants |
| High Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale | Ordinal Scale 4 | 11 Participants |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Overall | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14 | Ordinal Scale 1 | 36 Participants |
| Overall | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14 | Ordinal Scale 6 | 85 Participants |
| Overall | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14 | Ordinal Scale 5 | 38 Participants |
| Overall | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14 | Ordinal Scale 2 | 15 Participants |
| Overall | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14 | Ordinal Scale 7 | 206 Participants |
| Overall | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14 | Ordinal Scale 3 | 22 Participants |
| Overall | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14 | Ordinal Scale 4 | 44 Participants |
| Low Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14 | Ordinal Scale 6 | 11 Participants |
| Low Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14 | Ordinal Scale 4 | 8 Participants |
| Low Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14 | Ordinal Scale 3 | 5 Participants |
| Low Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14 | Ordinal Scale 5 | 11 Participants |
| Low Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14 | Ordinal Scale 7 | 40 Participants |
| Low Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14 | Ordinal Scale 2 | 1 Participants |
| Low Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14 | Ordinal Scale 1 | 5 Participants |
| Medium Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14 | Ordinal Scale 4 | 28 Participants |
| Medium Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14 | Ordinal Scale 1 | 17 Participants |
| Medium Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14 | Ordinal Scale 2 | 13 Participants |
| Medium Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14 | Ordinal Scale 3 | 11 Participants |
| Medium Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14 | Ordinal Scale 5 | 26 Participants |
| Medium Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14 | Ordinal Scale 6 | 56 Participants |
| Medium Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14 | Ordinal Scale 7 | 142 Participants |
| High Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14 | Ordinal Scale 3 | 6 Participants |
| High Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14 | Ordinal Scale 7 | 24 Participants |
| High Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14 | Ordinal Scale 6 | 18 Participants |
| High Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14 | Ordinal Scale 2 | 1 Participants |
| High Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14 | Ordinal Scale 1 | 14 Participants |
| High Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14 | Ordinal Scale 5 | 1 Participants |
| High Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14 | Ordinal Scale 4 | 8 Participants |
Secondary
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
Population: Hospitalised Adults with COVID-19 who received at least one dose of remdesivir.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Overall | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28 | Ordinal Scale 1 | 52 Participants |
| Overall | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28 | Ordinal Scale 6 | 27 Participants |
| Overall | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28 | Ordinal Scale 5 | 8 Participants |
| Overall | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28 | Ordinal Scale 2 | 4 Participants |
| Overall | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28 | Ordinal Scale 7 | 333 Participants |
| Overall | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28 | Ordinal Scale 3 | 6 Participants |
| Overall | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28 | Ordinal Scale 4 | 14 Participants |
| Low Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28 | Ordinal Scale 6 | 5 Participants |
| Low Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28 | Ordinal Scale 4 | 1 Participants |
| Low Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28 | Ordinal Scale 3 | 4 Participants |
| Low Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28 | Ordinal Scale 5 | 1 Participants |
| Low Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28 | Ordinal Scale 7 | 64 Participants |
| Low Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28 | Ordinal Scale 2 | 0 Participants |
| Low Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28 | Ordinal Scale 1 | 5 Participants |
| Medium Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28 | Ordinal Scale 4 | 9 Participants |
| Medium Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28 | Ordinal Scale 1 | 30 Participants |
| Medium Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28 | Ordinal Scale 2 | 4 Participants |
| Medium Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28 | Ordinal Scale 3 | 0 Participants |
| Medium Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28 | Ordinal Scale 5 | 7 Participants |
| Medium Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28 | Ordinal Scale 6 | 15 Participants |
| Medium Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28 | Ordinal Scale 7 | 227 Participants |
| High Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28 | Ordinal Scale 3 | 2 Participants |
| High Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28 | Ordinal Scale 7 | 42 Participants |
| High Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28 | Ordinal Scale 6 | 7 Participants |
| High Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28 | Ordinal Scale 2 | 0 Participants |
| High Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28 | Ordinal Scale 1 | 17 Participants |
| High Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28 | Ordinal Scale 5 | 0 Participants |
| High Disease Severity at Baseline | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28 | Ordinal Scale 4 | 4 Participants |
Secondary
Duration of ICU
Number of days spent in ICU
Time frame: through study completion, 28 days
Population: Hospitalised Adults with COVID-19 who received at least one dose of remdesivir.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall | Duration of ICU | 13 days |
| Low Disease Severity at Baseline | Duration of ICU | 10 days |
| Medium Disease Severity at Baseline | Duration of ICU | 17 days |
| High Disease Severity at Baseline | Duration of ICU | 10 days |
Secondary
Duration of Oxygen Therapy
Median (IQR) duration on oxygen therapy by day 28.
Time frame: Day 28
Population: Full population analysis - All enrolled participants who met the eligibility criteria and with data available at baseline will be included in the Full Analysis Population. Disease severity was grouped based on oxygen support requirement at baseline: no supple-mental oxygen (NSO), LFO(≤6 litres (l)/minute), and HFO (\>6 l/ minute).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall | Duration of Oxygen Therapy | 6 days |
| Low Disease Severity at Baseline | Duration of Oxygen Therapy | 5 days |
| Medium Disease Severity at Baseline | Duration of Oxygen Therapy | 6 days |
| High Disease Severity at Baseline | Duration of Oxygen Therapy | 6 days |
Secondary
Duration of Remdesivir Use
Median (IQR) duration of use of remdesivir
Time frame: Day 28
Population: Full population analysis - All enrolled participants who met the eligibility criteria and with data available at baseline will be included in the Full Analysis Population. Disease severity was grouped based on oxygen support requirement at baseline: no supple-mental oxygen (NSO), LFO(≤6 litres (l)/minute), and HFO (\>6 l/ minute).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall | Duration of Remdesivir Use | 5 days |
| Low Disease Severity at Baseline | Duration of Remdesivir Use | 5 days |
| Medium Disease Severity at Baseline | Duration of Remdesivir Use | 5 days |
| High Disease Severity at Baseline | Duration of Remdesivir Use | 5 days |
Secondary
ICU Admission
Intensive care unit admission over entire study period
Time frame: Day 28
Population: Full population analysis - All enrolled participants who met the eligibility criteria and with data available at baseline will be included in the Full Analysis Population. Disease severity was grouped based on oxygen support requirement at baseline: no supple-mental oxygen (NSO), LFO(≤6 litres (l)/minute), and HFO (\>6 l/ minute).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall | ICU Admission | 55 participants |
| Low Disease Severity at Baseline | ICU Admission | 3 participants |
| Medium Disease Severity at Baseline | ICU Admission | 33 participants |
| High Disease Severity at Baseline | ICU Admission | 19 participants |
Secondary
Mechanical Ventilation/ECMO Use
Use of mechanical ventilation/ECMO (extracorporeal membrane oxygenation) over study period
Time frame: Day 28
Population: Full population analysis - All enrolled participants who met the eligibility criteria and with data available at baseline will be included in the Full Analysis Population. Disease severity was grouped based on oxygen support requirement at baseline: no supple-mental oxygen (NSO), LFO(≤6 litres (l)/minute), and HFO (\>6 l/ minute).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall | Mechanical Ventilation/ECMO Use | 25 participants |
| Low Disease Severity at Baseline | Mechanical Ventilation/ECMO Use | 3 participants |
| Medium Disease Severity at Baseline | Mechanical Ventilation/ECMO Use | 17 participants |
| High Disease Severity at Baseline | Mechanical Ventilation/ECMO Use | 5 participants |
Secondary
Readmission With COVID-19 Complications
Re-admission with COVID-19 complications or recurrence within 28 days of discharge and outcome
Time frame: Day 28
Population: Full population analysis - All enrolled participants who met the eligibility criteria and with data available at baseline will be included in the Full Analysis Population. Disease severity was grouped based on oxygen support requirement at baseline: no supple-mental oxygen (NSO), LFO(≤6 litres (l)/minute), and HFO (\>6 l/ minute).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overall | Readmission With COVID-19 Complications | 16 Participants |
| Low Disease Severity at Baseline | Readmission With COVID-19 Complications | 3 Participants |
| Medium Disease Severity at Baseline | Readmission With COVID-19 Complications | 11 Participants |
| High Disease Severity at Baseline | Readmission With COVID-19 Complications | 2 Participants |
Secondary
SpO2 > 94% on Room Air
Number of participants SpO2 \> 94% on room air by day 28
Time frame: Day 28
Population: Adults with hospitalised COVID-19 who received at least one dose of remdesivir
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overall | SpO2 > 94% on Room Air | 154 Participants |
| Low Disease Severity at Baseline | SpO2 > 94% on Room Air | 22 Participants |
| Medium Disease Severity at Baseline | SpO2 > 94% on Room Air | 113 Participants |
| High Disease Severity at Baseline | SpO2 > 94% on Room Air | 19 Participants |
Secondary
Timing From Hospitalisation to Remdesivir Exposure
Median (IQR) time from hospitalisation to use of remdesivir
Time frame: Day 28
Population: Full population analysis - All enrolled participants who met the eligibility criteria and with data available at baseline will be included in the Full Analysis Population. Disease severity was grouped based on oxygen support requirement at baseline: no supple-mental oxygen (NSO), LFO(≤6 litres (l)/minute), and HFO (\>6 l/ minute).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall | Timing From Hospitalisation to Remdesivir Exposure | 1 days |
| Low Disease Severity at Baseline | Timing From Hospitalisation to Remdesivir Exposure | 2 days |
| Medium Disease Severity at Baseline | Timing From Hospitalisation to Remdesivir Exposure | 1 days |
| High Disease Severity at Baseline | Timing From Hospitalisation to Remdesivir Exposure | 1 days |
Secondary
Timing of Remdesivir Exposure
Median (IQR) time from first symptoms to use of remdesivir
Time frame: Day 28
Population: Full population analysis - All enrolled participants who met the eligibility criteria and with data available at baseline will be included in the Full Analysis Population. Disease severity was grouped based on oxygen support requirement at baseline: no supple-mental oxygen (NSO), LFO(≤6 litres (l)/minute), and HFO (\>6 l/ minute).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall | Timing of Remdesivir Exposure | 7 days |
| Low Disease Severity at Baseline | Timing of Remdesivir Exposure | 7 days |
| Medium Disease Severity at Baseline | Timing of Remdesivir Exposure | 7 days |
| High Disease Severity at Baseline | Timing of Remdesivir Exposure | 7 days |