Status:
COMPLETED
AZD1656 in Diabetic Patients Hospitalised With Suspected or Confirmed COVID-19
Lead Sponsor:
St George Street Capital
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 COV...
Detailed Description
The ARCADIA Trial will assess the safety and efficacy of AZD1656 in 150 patients with either Type 1 or Type 2 diabetes who have been hospitalised with COVID-19. AZD1656 is a glucokinase (GK; hexokina...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2021
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT04516759
Start Date
August 12 2020
End Date
May 12 2021
Last Update
April 25 2022
Active Locations (30)
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1
Masarykova Univerzita - Fakultni Nemocnice U SV Anny V Brne (308)
Brno, Czechia
2
Nemocnice Hořovice (309)
Hořovice, Czechia
3
Oblastni Nemocnice Kolín (306)
Kolín, Czechia
4
Klaudianova Nemonice (302)
Mladá Boleslav, Czechia