A randomised, double-blind, placebo-controlled, multicentre clinical trial of AZD1656 in diabetic patients hospitalised with COVID-19: The ARCADIA Trial - implications for therapeutic immune modulation.

ABSTRACT:

Background

A potential immunotherapeutic role for AZD1656 (a glucokinase activator) in the treatment of COVID-19 was hypothesized. The ARCADIA trial investigated the safety and efficacy of AZD1656 in diabetic patients admitted to hospital with COVID-19.

Methods

The ARCADIA trial was a Phase II randomised, double-blind, placebo-controlled clinical trial. Adult diabetic patients, admitted with COVID-19, were recruited at 28 hospitals in the UK, Romania and Czech Republic and randomly assigned (1:1) to receive AZD1656 tablets (100mg twice a day), or matched placebo, for up to 21 days, in addition to usual care. All involved were masked to treatment allocation. The primary endpoint was clinical improvement measured at Day 14. The Full Analysis Set (FAS) included all patients who

SUBMITTER: Chorlton J 

PROVIDER: S-EPMC9386394 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature