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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Target Population | Adults with COVID-19 diagnosed and treated with Remdesivir after Aug 31st2020. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remdesivir | Drug | treated with Remdesivir |
|
| Measure | Description | Time Frame |
|---|---|---|
| All Case Mortality by Day 28 | Occurrence of death within 28 days. | Day 28 |
| Duration of Hopitalisation | Number of hospital discharges by day 28. | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
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Inclusion Criteria:
All Adult participants with COVID-19 confirmed by PCR who meet the following criteria:
Exclusion Criteria:
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Adults with COVID-19 diagnosed and treated with Remdesivir after Aug 31st2020.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nantes | Nantes | France | ||||
| Hospital Lariboisiere |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37454762 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cases | Adults with COVID-19 diagnosed and treated with Remdesivir after Aug 31st, 2020.
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| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cases | Adults with COVID-19 diagnosed and treated with Remdesivir after Aug 31st, 2020.
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | All Case Mortality by Day 28 | Occurrence of death within 28 days. | 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). | Posted | Number | participants | Day 28 |
|
Day 28
All cause mortality was collected throughout the study period. All other adverse events (not including all cause mortality) were not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Adults with COVID-19 diagnosed and treated with Remdesivir after Aug 31st 2020. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mortality | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Toni Sobande, Clinical Project Manager | Research Organisation King's Cross (KC) Ltd. | 447494 795 982 | toni.sobande@rokcservices.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 17, 2020 | Aug 8, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 7, 2021 | Aug 9, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000606551 | remdesivir |
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| Day 7 |
| Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14 | 7-point ordinal scale:
| 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:
| 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:
| Day 28 |
| SpO2 > 94% on Room Air | Number of participants SpO2 > 94% on room air by day 28 | Day 28 |
| Duration of Oxygen Therapy | Median (IQR) duration on oxygen therapy by day 28. | Day 28 |
| ICU Admission | Intensive care unit admission over entire study period | Day 28 |
| Duration of ICU | Number of days spent in ICU | through study completion, 28 days |
| Mechanical Ventilation/ECMO Use | Use of mechanical ventilation/ECMO (extracorporeal membrane oxygenation) over study period | Day 28 |
| Timing of Remdesivir Exposure | Median (IQR) time from first symptoms to use of remdesivir | Day 28 |
| Timing From Hospitalisation to Remdesivir Exposure | Median (IQR) time from hospitalisation to use of remdesivir | Day 28 |
| Duration of Remdesivir Use | Median (IQR) duration of use of remdesivir | Day 28 |
| Readmission With COVID-19 Complications | Re-admission with COVID-19 complications or recurrence within 28 days of discharge and outcome | Day 28 |
| Paris |
| 75010 |
| France |
| Hopital Saint-Louis | Paris | France |
| Tel Aviv Sourasky Medical Center | Tel Aviv | Israel |
| Erasmus Medical Center | Rotterdam | 3015 | Netherlands |
| Hospital Germans Trias i Pujol | Barcelona | 08916 | Spain |
| Hospital ClÃnic de Barcelona | Barcelona | Spain |
| Hospital Universitari Vall d'Herbon | Barcelona | Spain |
| Hospital Clinico Universitario San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Royal Free Hospital | London | NW3 2QG | United Kingdom |
| Chelsea & Westminster Hospital | London | SW10 9NH | United Kingdom |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Pregnant women, n (%) | Count of Participants | Participants |
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| Body mass index (BMI, Kg/m²) | Median | Inter-Quartile Range | Kg/m² |
|
| Comorbidities | Count of Participants | Participants |
|
| NEWS2 score | NEWS2 is a summary score of six physiological parameters (respiratory rate, oxygen saturation, systolic blood pressure, heart rate, level of consciousness, temperature, and supplemental oxygen dependency) recorded routinely when patients present or are admitted to hospital. These parameters are used 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. | Of the total 448 cases, 391 had sufficient baseline data recorded to enable a NEWS2 score to be calculated and were thus included in this analysis | Count of Participants | Participants |
|
| SpO2 (%) | Count of Participants | Participants |
|
| Other Treatment for COVID-19, n (%) | Count of Participants | Participants |
|
| OG002 | Medium Disease Severity at Baseline | Low to medium disease defined by low flow oxygen support (≤6 litres (l)/minute) |
| OG003 | High Disease Severity at Baseline | High disease severity at baseline defined by high flow oxygen support (>6 litres (l)/minute |
|
|
| Primary | Duration of Hopitalisation | Number of hospital discharges by day 28. | 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). | Posted | Number | participants | Day 28 |
|
|
|
| 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:
| Hospitalised adult patients with COVID-19 who received at least one dose of remdesivir during their hospital admission. | Posted | Count of Participants | Participants | Day 7 |
|
|
|
| Secondary | Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14 | 7-point ordinal scale:
| Posted | Count of Participants | Participants | Day 14 |
|
|
|
| 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:
| 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 | Posted | Count of Participants | Participants | Day 7, 14, and 28 |
|
|
|
| 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:
| Hospitalised Adults with COVID-19 who received at least one dose of remdesivir. | Posted | Count of Participants | Participants | Day 28 |
|
|
|
| Secondary | SpO2 > 94% on Room Air | Number of participants SpO2 > 94% on room air by day 28 | Adults with hospitalised COVID-19 who received at least one dose of remdesivir | Posted | Count of Participants | Participants | Day 28 |
|
|
|
| Secondary | Duration of Oxygen Therapy | Median (IQR) duration on oxygen therapy by day 28. | 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). | Posted | Median | Inter-Quartile Range | days | Day 28 |
|
|
|
| Secondary | ICU Admission | Intensive care unit admission over entire study period | 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). | Posted | Number | participants | Day 28 |
|
|
|
| Secondary | Duration of ICU | Number of days spent in ICU | Hospitalised Adults with COVID-19 who received at least one dose of remdesivir. | Posted | Median | Inter-Quartile Range | days | through study completion, 28 days |
|
|
|
| Secondary | Mechanical Ventilation/ECMO Use | Use of mechanical ventilation/ECMO (extracorporeal membrane oxygenation) over study period | 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). | Posted | Number | participants | Day 28 |
|
|
|
| Secondary | Timing of Remdesivir Exposure | Median (IQR) time from first symptoms to use of remdesivir | 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). | Posted | Median | Inter-Quartile Range | days | Day 28 |
|
|
|
| Secondary | Timing From Hospitalisation to Remdesivir Exposure | Median (IQR) time from hospitalisation to use of remdesivir | 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). | Posted | Median | Inter-Quartile Range | days | Day 28 |
|
|
|
| Secondary | Duration of Remdesivir Use | Median (IQR) duration of use of remdesivir | 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). | Posted | Median | Inter-Quartile Range | days | Day 28 |
|
|
|
| Secondary | Readmission With COVID-19 Complications | Re-admission with COVID-19 complications or recurrence within 28 days of discharge and outcome | 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). | Posted | Count of Participants | Participants | Day 28 |
|
|
|
| 52 |
| 448 |
| 52 |
| 448 |
| 0 |
| 0 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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