N/A
Completed N=448
Study to Evaluate the Clinical Outcomes in Adults With Covid-19 Who Have Been Treated With Remdesivir.
Source: ClinicalTrials.gov NCT04847622 ↗Enrolled (actual)
448
Serious AEs
11.6%
Results posted
Nov 2024
Primary outcomePrimary: All Case Mortality by Day 28 — 52; 5; 30; 17 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All Case Mortality by Day 28 |
52; 5; 30; 17 | — |
| PRIMARY Duration of Hopitalisation |
369; 69; 248; 52 | — |
| SECONDARY Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale |
10; 2; 3; 5; 13; 1 | — |
| SECONDARY Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14 |
36; 5; 17; 14; 15; 1 | — |
| SECONDARY Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score |
2; 3; 4; 9; 3; 4 | — |
| SECONDARY Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28 |
52; 5; 30; 17; 4; 0 | — |
| SECONDARY SpO2 > 94% on Room Air |
154; 22; 113; 19 | — |
| SECONDARY Duration of Oxygen Therapy |
6; 5; 6; 6 | — |
| SECONDARY ICU Admission |
55; 3; 33; 19 | — |
| SECONDARY Duration of ICU |
13; 10; 17; 10 | — |
| SECONDARY Mechanical Ventilation/ECMO Use |
25; 3; 17; 5 | — |
| SECONDARY Timing of Remdesivir Exposure |
7; 7; 7; 7 | — |
| SECONDARY Timing From Hospitalisation to Remdesivir Exposure |
1; 2; 1; 1 | — |
| SECONDARY Duration of Remdesivir Use |
5; 5; 5; 5 | — |
| SECONDARY Readmission With COVID-19 Complications |
16; 3; 11; 2 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04847622). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.