Effect of Two Different Doses of Dexamethasone in Patients With ARDS and COVID-19

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.

Conditions

• Covid19
• ARDS

Interventions

DRUG

Dexamethasone

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 If successful extubation occurs before day 10, treatment with dexamethasone is withdrawn.

Sponsors & Collaborators

• Masaryk University

  collaborator OTHER

• Vascular surgery, University hospital Královské Vinohrady, Prague

  collaborator OTHER

• General University Hospital, Prague

  collaborator OTHER

• University Hospital Ostrava

  collaborator OTHER

• St. Anne's University Hospital Brno

  collaborator UNKNOWN

• Motol University Hospital

  collaborator OTHER

• University Hospital Olomouc

  collaborator OTHER

• University Hospital Plzeň

  collaborator UNKNOWN

• Tomáš Baťa Regional Hospital

  collaborator UNKNOWN

• Military University Hospital Praha

  collaborator UNKNOWN

• Brno University Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-02-02

Primary Completion

2022-03-09

Completion

2023-02-23

Countries

• Czechia

Study Locations