Table 1

Primary, secondary and exploratory objectives of ARCADIA (including measurement variables)

Objectives
Primary objective	To determine the effect of AZD1656 on the cardiorespiratory complications of COVID-19 in hospitalised patients with diabetes with known or suspected COVID-19, as measured using the WHO 8-point Ordinal Scale for Clinical Improvement (see figure 1) compared with placebo.
Secondary objectives	To assess the extent to which AZD1656 supports maintenance of adequate glycaemic control in hospitalised patients with diabetes with known or suspected COVID-19.*
	To assess the safety and tolerability of AZD1656 in the management of diabetes in hospitalised patients with diabetes with known or suspected COVID-19.
	To determine whether AZD1656 affects duration of hospital stay, requirement for mechanical ventilation or mortality in patients with diabetes with known or suspected COVID-19.
Exploratory objectives	To determine the pharmacokinetics (PK) of AZD1656 in patients with diabetes with known or suspected COVID-19.
	To explore the effects of AZD1656 on immunophenotyping characteristics during COVID-19 infection in hospitalised patients with diabetes.
	To explore the effects of AZD1656 on immunochemistry characteristics during COVID-19 infection in hospitalised patients with diabetes.
	To explore whether AZD1656 affects the extent of any cardiac injury related to COVID-19 in hospitalised patients with diabetes.
	To explore if ethnicity affects the clinical outcome of hospitalised patients with diabetes with known or suspected COVID-19 treated with AZD1656 versus placebo.
	To explore if 25-hydroxyvitamin D levels at baseline affect the clinical outcome of hospitalised patients with diabetes with known or suspected COVID-19 treated with AZD1656 versus placebo.

*As measured by the need to increase baseline medication requirements or the need to add additional diabetic medications to maintain appropriate blood glucose levels.