CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 235 enrolled
Drug / intervention
Dexamethasonedrug
Likely dose
Dexamethasone 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04663555
NCT04663555Phase 4Completed
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Effect of Dexamethasone in Patients With ARDS and COVID-19 - Prospective, Multi-centre, Open-label, Parallel-group, Randomized Controlled Trial (REMED Trial)

Brno University Hospital·interventional·Posted Dec 11, 2020·Updated Mar 22, 2023

In Brief

A Phase 4 clinical trial evaluating Dexamethasone for Covid19 and ARDS. Completed, enrolled 235 participants across 1 site.

Detailed Summary

REMED is a prospective, phase II, open-label, randomised controlled trial testing superiority of dexamethasone 20 mg vs 6 mg. The trial aims to be pragmatic, i.e. designed to evaluate the effectiveness of the intervention in conditions that are close to real-life routine clinical practice. The study is multi-centre and will be conducted in the intensive care units (ICUs) of ten university hospitals in the Czech Republic. This is an open-label trial in which the participants and the study staff will be aware of the allocated intervention. Blinded pre-planned statistical analysis will be performed.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCovid19, ARDS
CountriesCzechia
CollaboratorsMasaryk University, Vascular surgery, University hospital Královské Vinohrady, Prague, General University Hospital, Prague, University Hospital Ostrava, St. Anne's University Hospital Brno, Czech Republic, Motol University Hospital, University Hospital Olomouc, University Hospital Plzeň, Tomáš Baťa Regional Hospital, Military University Hospital Praha

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedDec 11, 2020
Enrollment StartFeb 2, 2021
Primary CompletionMar 9, 2022
Study CompletionFeb 23, 2023
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 5.6 years ago

Interventions

Dexamethasonedrug

Patients in the intervention group after randomization will receive dexamethasone 20 mg intravenously once daily on day 1-5, followed by dexamethasone 10 mg intravenously once daily on day 6-10. If successful extubation occurs before day 10, treatment with dexamethasone is withdrawn.