COVID-19 MedDRA version: 23.0 Level: LLT Classification code 10084382 Term: Coronavirus disease 2019 System Organ Class: 100000004862
Conditions
Interventions
Product Name: AZD1656
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: AZD1656
Current Sponsor code: AZD1656
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration num
Sponsors
St George Street Capital Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or Female. 2. Aged 18 and older. 3. Have either T1DM or T2DM. 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of AZD1656 on the cardiorespiratory complications of COVID-19 in hospitalised diabetic patients with known or suspected COVID-19 disease, as measured using the WHO 8-point Ordinal Scale for Clinical Improvement compared to placebo.;Secondary Objective: Secondary objectives of this study are: • To assess the extent to which AZD1656 supports maintenance of adequate glycaemic control in hospitalised diabetic patients with known or suspected COVID-19. • To assess the safety and tolerability of AZD1656 in the management of diabetes in hospitalised diabetic patients with known or suspected COVID-19. • To determine whether AZD1656 affects duration of hospital stay, requirement for mechanical ventilation or mortality in diabetic patients with known or suspected COVID-19.;Primary end point(s): Clinical Improvement measured as the percentage of subjects at Day 14 who are in categories 1-3 according to the World Health Organization (WHO) 8-point Ordinal Scale for Clinical Improvement, comparing AZD1656 treatment to placebo.;Timepoint(s) of evaluation of this end point: Please refer to protocol for details. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Clinical Improvement measured as the percentage of patients categorised at each severity rating on the WHO 8-point Ordinal Scale at Day 7, Day 14 and Day 21 versus baseline, comparing AZD1656 treatment with placebo. • Degree of glycaemic control as measured by the need to increase baseline medication requirements or the need to add additional diabetic medications to maintain appropriate blood glucose levels in patients receiving AZD1656 compared with placebo. • Proportion of Treatment Emergent Adverse Events (TEAEs) leading to study drug discontinuation in patients receiving AZD1656 compared with placebo. • Proportion of Serious Adverse Events (SAEs) in patients receiving AZD1656 compared with placebo. • Time from hospital admission to hospital discharge (in hours) in patients receiving AZD1656 compared with placebo. • Time from hospital admission to receiving intubation/mechanical ventilation in patients receiving AZD1656 compared with placebo. • Mortality Rate in patients receiving AZD1656 compared with placebo.;Timepoint(s) of evaluation of this end point: Please refer to protocol for details. | — |
Countries
United Kingdom
Contacts
Public ContactClinical Trials
St George Street Capital Ltd
Outcome results
None listed