AZD1656 in Diabetic Patients Hospitalised With Suspected or Confirmed COVID-19
Condition: Covid19
MeSH terms: COVID-19
Intervention: AZD1656; Placebo
Intervention description: 50mg film-coated tablets (at daily dose of 100mg BID); Matched placebo tablets
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomised double-blind study. Eligible patients will be randomly assigned to one of two groups (AZD1656 plus usual care or placebo plus usual care) on a 1:1 basis
Masking: Double (Participant, Investigator)
Enrollment: 170.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID-19; Diabetes Mellitus; SARS-CoV-2; Regulatory T Cell; Glucokinase

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.
    

Eligibility 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.