Clinical trial NCT04847622: Study to Evaluate the Clinical Outcomes in Adults With Covid-19 Who Have Been Treated With Remdesivir.
Official title: A Multi-centre, Multi-country Retrospective Cohort Study to Evaluate the Clinical Outcomes in Adults With Covid-19 Who Have Been Treated With Remdesivir.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: NEAT ID Foundation
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2021-04-19
Enrollment: 451
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with COVID-19 diagnosed and treated with Remdesivir after Aug 31st2020.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: All Case Mortality by Day 28
timeFrame: Day 28
measure: Duration of Hopitalisation
timeFrame: Day 28
Secondary outcomes:
measure: Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale
timeFrame: Day 7
measure: Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14
timeFrame: Day 14
measure: Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score
timeFrame: Day 7, 14, and 28
measure: Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28
timeFrame: Day 28
measure: SpO2 > 94% on Room Air
timeFrame: Day 28
measure: Duration of Oxygen Therapy
timeFrame: Day 28
measure: ICU Admission
timeFrame: Day 28
measure: Duration of ICU
timeFrame: through study completion, 28 days
measure: Mechanical Ventilation/ECMO Use
timeFrame: Day 28
measure: Timing of Remdesivir Exposure
timeFrame: Day 28
measure: Timing From Hospitalisation to Remdesivir Exposure
timeFrame: Day 28
measure: Duration of Remdesivir Use
timeFrame: Day 28
measure: Readmission With COVID-19 Complications
timeFrame: Day 28
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: Hospital Lariboisiere
city: Paris
country: France
facility: Hopital Saint-Louis
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Barcelona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Herbon
city: Madrid
country: Spain
facility: Hospital Clinico Universitario San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: Chelsea & Westminster Hospital
Study officials:
References: