CompletedPhase 2

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

Czechia170 participantsStarted 2020-08-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Clinical Improvement by Day 14

Timeframe: Day 1 to Day 14

Trial details

NCT IDNCT04516759

SponsorSt George Street Capital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-04-25

Results submitted2022-04-12

View on ClinicalTrials.gov More Covid19 trials