Phase 2
Completed N=153
AZD1656 in Diabetic Patients Hospitalised With Suspected or Confirmed COVID-19
Source: ClinicalTrials.gov NCT04516759 ↗Enrolled (actual)
153
Serious AEs
19.0%
Results posted
Apr 2022
Primary outcomePrimary: Clinical Improvement by Day 14 — 61; 51; 18; 21 Participants — p=0.1854
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Improvement by Day 14 |
61; 51; 18; 21; 1; 1 | 0.1854 |
| SECONDARY Clinical Improvement at Day 7, 14 and 21 |
0; 0; 0; 0; 19; 13 | 0.0286 sig |
| SECONDARY Glycaemic Control |
12; 13; 68; 60; 61; 58 | 0.4006 |
| SECONDARY Occurrence of Adverse Events |
2; 2; 28; 21 | 0.5875 |
| SECONDARY Occurrence of Serious Adverse Events |
4; 7; 28; 17 | 0.1129 |
| SECONDARY Duration of Hospitalisation |
264.3; 288.7 | 0.1556 |
| SECONDARY Mortality Rate |
0; 6; 79; 66; 1; 1 | 0.0105 sig |
| SECONDARY Intubation/Mechanical Ventilation |
3; 3; 76; 69; 1; 1 | 0.6144 |
Eligibility Criteria
Inclusion Criteria
- Male or Female.
- Aged 18 and older.
- Have either Type I or Type II Diabetes Mellitus.
- 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.
- Blood glucose level at or above 4 mmol/L.
- Able to take oral (tablet) formulation of medication.
- Patient is able to provide written informed consent prior to initiation of any study procedures.
Exclusion Criteria
- 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.
- Patients admitted with primary suspected or proven Mycoplasma pneumoniae, Chlamydia pneumoniae and bacterial pneumonia, who acquired COVID-19 while hospitalized.
- Treatment with immunomodulators or anti-rejection drugs within the last 3 months.
- Pregnant or breast feeding.
- 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.
- Anticipated transfer to another hospital which is not a study site within 72 hours.
- Known sensitivity to any of the study medication/placebo excipients.
- Prior dosing with AZD1656 on a previous clinical trial.
- Patients admitted as a result of and receiving immediate treatment for an acute asthmatic attack, acute myocardial infarction, acute cerebrovascular event.
- 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.
- Known history of drug or alcohol abuse within previous 12 months of screening.
- Known history of HIV, hepatitis C or unresolved hepatitis B or severe liver disease.
- Current or planned use of gemfibrozil or any other strong inhibitors of CYP2C8.
- 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.
Data sourced from ClinicalTrials.gov (NCT04516759). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.