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

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-centre, Multi-country Retrospective Cohort Study to Evaluate the Clinical Outcomes in Adults With Covid-19 Who Have Been Treated With Remdesivir.

Conditions
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Covid19

Intervention / Treatment
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* Drug: Remdesivir


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Target Population<br>Adults with COVID-19 diagnosed and treated with Remdesivir after Aug 31st2020. | Drug: Remdesivir<br>* treated with Remdesivir<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | All-cause mortality | Day 28 | 
| Clinical status assessed by a 7-point ordinal scale | 7-point ordinary scale: Death Hospitalised, on invasive mechanical ventilation or ECMO Hospitalised, on non-invasive ventilation or high flow oxygen devices Hospitalised, requiring low flow supplemental oxygen Hospitalised, not requiring supplemental oxygen -requiring ongoing medical care (COVID-19 related or otherwise) Hospitalised, not requiring supplemental oxygen -no longer requires ongoing medical care Not hospitalised | Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of clinical improvement. | Proportion of clinical improvement at Day 14, defined as a ≥ 2-point improvement from Day 1 on a 7-point ordinal scale | Day 14 | 
| Severity of disease | Severity of disease on Day 7, Day 14 and Day 28 based on NEWS 2 score | Day 28 | 
| Clinical status assessed by a 7-point ordinal scale | Clinical status assessed by a 7-point ordinal scale on Day 28 (or at last observation if discharged or died prior to this time point) in those still Hospitalised after day 14. | Day 28 | 
| Time to SpO2 | Time to SpO2 > 94% on room air (number of days when evaluation made on day 7, 14 or 28) | Day 28 | 
| Duration of oxygen therapy | Duration of oxygen therapy (total days) | through study completion, an average of 1 month | 
| Admission to the Intensive Care Unit | Admission of a subject to the Intensive Care Unit | through study completion, an average of 1 month | 
| Time on mechanical ventilation/ECMO | Need for and time on mechanical ventilation/ECMO of hospitalisation | through study completion, an average of 1 month | 
| Duration of hospitalisation | Duration of hospitalisation in days | through study completion, an average of 1 month |