CLINICAL TRIAL REMEDY
Effect of dexamethasone in patients with ARDS and COVID-19 – a prospective, multicenter, open-label, randomized controlled trial with parallel groups.
COVID-19 is still a major challenge for medical research, with new drugs or possible optimization of existing drugs being investigated. One possibility to use an existing drug is the corticosteroid treatment dexamethasone. The REMED clinical trial is designed to test the hypothesis that administration of 20 mg dexamethasone daily is more effective compared to a daily dose of 6 mg dexamethasone in adult patients with moderate or severe ARDS related to COVID-19. The initiator of this multicentre study is the University Hospital Brno – Department of Anaesthesiology, Resuscitation and Intensive Care Medicine, which in collaboration with VI CZECRIN is conducting the study in 10 centres in the Czech Republic in 300 patients.
OVERVIEW OF RECRUITMENT
Recruitment for the REMED clinical trial was terminated as of 9 March 2022 due to the receding pandemic. A total of 235 patients were enrolled in the study out of 300 planned. The infographic below shows the percentage of recruitment fulfilled and the involvement of collaborating sites.
Important links to the project
| Access to REDCap database (for examiners) | KH registration on ClinicalTrials.gov | EU Clinical Trials Register |
| Publication Protocol – short version | Publication Protocol – full version |
REMED is part of a planned prospective meta-analysis of clinical trials comparing higher and standard doses of dexamethasone in patients with COVID-19 and hypoxia – protocol is registered here.
Project documents
| Approval of KH MEK FN Brno | REMED Data and Safety Monitoring Board |
| Interim analysis – report | Informed consent (short version) |
If you are interested in the full version of the ICF, or other KH documentation, please contact karolina.grodova@med.muni.cz
Contact
National coordinator of KH REMED:
MUDr. Jan Maláska, Ph.D. | jan.malaska@med.muni.cz | +420 532 232 009
Project Manager:
Ing. Karolína Grodová | karolina.grodova@med.muni.cz