AZD1656 in Diabetic Patients Hospitalised With Suspected or Confirmed COVID-19

• Status: Completed
• Trial end date: 2021-05-12
• Target enrollment: 0
• Participant gender: All

Summary

The ARCADIA Trial is a randomised, double-blind, placebo-controlled clinical trial to assess the safety and efficacy of AZD1656 in patients with either Type 1 or Type 2 diabetes, hospitalised with COVID-19.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St George Street Capital

Criteria

Inclusion Criteria:

1. Male or Female.

2. Aged 18 and older.

3. Have either Type I or Type II Diabetes Mellitus.

4. Hospitalised with suspected or confirmed novel coronavirus (Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)) infection at time of enrolment, categorised as stage 3, 4 or 5 on the WHO Ordinal Scale for Clinical Improvement.

5. Blood glucose level at or above 4 mmol/L.

6. Able to take oral (tablet) formulation of medication.

7. Patient is able to provide written informed consent prior to initiation of any study procedures.

Exclusion Criteria:

1. In the opinion of the clinical team, progression to intubation or mechanical ventilation is imminent and inevitable, within the next 24 hours, irrespective of the provision of treatments.

2. Patients admitted with primary suspected or proven Mycoplasma pneumoniae, Chlamydia pneumoniae and bacterial pneumonia, who acquired COVID-19 while hospitalized.

3. Treatment with immunomodulators or anti-rejection drugs within the last 3 months.

4. Pregnant or breast feeding.

5. Men, and women of child-bearing potential, unwilling to use highly effective contraception during their participation in the trial and for 2 weeks after study completion.

6. Anticipated transfer to another hospital which is not a study site within 72 hours.

7. Known sensitivity to any of the study medication/placebo excipients.

8. Prior dosing with AZD1656 on a previous clinical trial.

9. Patients admitted as a result of and receiving immediate treatment for an acute asthmatic attack, acute myocardial infarction, acute cerebrovascular event.

10. Any known non-COVID-19, non-diabetes related, serious condition which, in the opinion of the clinical team, makes the patient unsuitable for the trial.

11. Known history of drug or alcohol abuse within previous 12 months of screening.

12. Known history of HIV, hepatitis C or unresolved hepatitis B or severe liver disease.

13. Current or planned use of gemfibrozil or any other strong inhibitors of CYP2C8.

14. Current or previous participation in another clinical trial where the patient has received a dose of an Investigational Medicinal Product (IMP) containing small molecule treatment(s) within 30 days or 5 half-lives (whichever is longer) prior to enrolment into this study, or containing biological treatment(s) within 3 months prior to entry into this study.