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Trial Acronym REALIST
Clinical Area Critical Care
Description Repair of Acute Respiratory Distress Syndrome by Stromal Cell Administration
Status Phase 2 (ARDS not due to COVID-19) – 2 as at 14/02/2022.
RECRUITMENT
Date Opened to Recruitment 21/11/2018
Target Recruitment Phase 2 (ARDS not due to COVID-19) – 60 participants
Phase 2 (ARDS due to COVID-19) – 60 participants
Phase 1 – Up to 18 participants
Recruitment to date Phase 2 (ARDS not due to COVID-19) – 5 as at 21/04/2022.
Phase 2 (ARDS due to COVID-19) – Recruitment complete.
Phase 1 – Recruitment complete.
TRIAL DESIGN
Trial Design An open label dose escalation phase 1 trial followed by a randomised, double-blind, allocation concealed, placebo-controlled trial.
Primary Objective: The primary objective is to assess the safety of a single intravenous infusion of MSCs in patients with ARDS due to either COVID-19 or other causes of ARDS.
Secondary Objective: Secondary objectives are to determine the effects of MSCs on:

1. Physiological indices of respiratory dysfunction reflecting severity of ARDS, as measured by oxygenation index (OI), respiratory compliance, and P/F ratio.

2.Sequential organ failure assessment (SOFA) score.

3.Extubation and reintubation.

4.Ventilation free days at day 28.

5. Duration of ventilation

6. Length of ICU and hospital stay.

7. 28-day and 90-day mortality.

CHIEF INVESTIGATOR (CI)
Chief Investigator Professor Danny McAuley
SPONSOR(s) & FUNDER(s)
Sponsor Belfast Health and Social Care Trust
Funder Wellcome Trust and Research and Development Division of the Public Health Agency Northern Ireland