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

NCT04516759 | Completed Phase 2 Results

• 2 other identifiers: SGS.1656.2012020-002211-21
• Study Type: interventional
• Target: 170
• Locations: 3 countries
• Sites: 30

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 COVID-19.

Conditions

Covid19

Keywords

COVID-19; Diabetes Mellitus; SARS-CoV-2; Regulatory T Cell; Glucokinase

Outcome Measures

Primary Outcomes (1)

• Clinical Improvement by Day 14

  The World Health Organization (WHO) 8-point Ordinal Scale for Clinical Improvement (OSCI) was used to measure Clinical Improvement at Day 14 versus baseline, comparing AZD1656 treatment with placebo. The WHO OSCI score ranges from 0-8 (0 = no symptoms, 8 = death). The higher the score the worse the condition of the patient. Results are presented as number of responders. Patients who were assigned a WHO score of 1, 2 or 3 at Day 14 were considered a treatment responder. A patient who was discharged before Day 14 was also considered a responder. All other patients (WHO scores 4-8 at Day 14) were considered treatment failures.

  Day 1 to Day 14

Secondary Outcomes (7)

• Clinical Improvement at Day 7, 14 and 21

  Day 1 to Day 21

• Glycaemic Control

  Day 1 to Day 21

• Occurrence of Adverse Events

  Day 1 to Day 28

• Occurrence of Serious Adverse Events

  Day 1 to Day 28

• Duration of Hospitalisation

  Day 1 to Day 21

Study Arms (2)

AZD1656 (plus Usual Hospital Care)

EXPERIMENTAL

50mg film-coated tablets at a dose of 100mg BID

Drug: AZD1656

Matched Placebo (plus Usual Hospital Care)

PLACEBO COMPARATOR

Matched placebo tablets

Other: Placebo

Interventions

AZD1656 DRUG

50mg film-coated tablets (at daily dose of 100mg BID)

AZD1656 (plus Usual Hospital Care)

Placebo OTHER

Matched placebo tablets

Matched Placebo (plus Usual Hospital Care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St George Street Capital: lead

Study Sites (30)

Masarykova Univerzita - Fakultni Nemocnice U SV Anny V Brne (308)

Brno, Czechia

Location

Nemocnice Hořovice (309)

Hořovice, Czechia

Location

Oblastni Nemocnice Kolín (306)

Kolín, Czechia

Location

Klaudianova Nemonice (302)

Mladá Boleslav, Czechia

Location

Fakultni Nemocnice V Motole (303)

Prague, Czechia

Location

Thomayerova Nemonice (310)

Prague, Czechia

Location

Nemocnice Třebíč (305)

Třebíč, Czechia

Location

Colentina Clinical Hospital (204)

Bucharest, Romania

Location

Spitalul Clinic de Boli Infectioase Cluj-Napoca (203)

Cluj-Napoca, Romania

Location

Spitalul Clinic de Pneumoftiziologie "Leon Daniello" Cluj-Napoca (202)

Cluj-Napoca, Romania

Location

Spitalul Clinic de Boli Infectioase Constanţa (207)

Constanța, Romania

Location

Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr Victor Babes Craiova (206)

Craiova, Romania

Location

Spitalul Judetean de Urgenta Deva (208)

Deva, Romania

Location

Spitalul Clinic de Boli Infectioase "Sfanta Parascheva" Iaşi (205)

Iași, Romania

Location

Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr Victor Babes Timişoara (201)

Timișoara, Romania

Location

Barnsley Hospital NHS Foundation Trust (105)

Barnsley, United Kingdom

Location

Bolton NHS Foundation Trust (122)

Bolton, United Kingdom

Location

Bradford Teaching Hospitals NHS Foundation Trust (103)

Bradford, BD9 6RJ, United Kingdom

Location

North Bristol NHS Trust (116)

Bristol, BS10 5NB, United Kingdom

Location

County Durham and Darlington NHS Foundation Trust (121)

Darlington, United Kingdom

Location

The Dudley Group NHS Foundation Trust (107)

Dudley, DY1 2HQ, United Kingdom

Location

Medway NHS Foundation Trust (108)

Gillingham, ME7 5NY, United Kingdom

Location

Hull & East Yorkshire NHS Trust (102)

Hull, United Kingdom

Location

Barts Health NHS Trust (101 and 111)

London, E1 1FR, United Kingdom

Location

Royal Free London NHS Foundation Trust (119)

London, NW3 2QG, United Kingdom

Location

St George's University Hospitals NHS Foundation Trust (114)

London, United Kingdom

Location

Penine Acute Hospitals NHS Trust (106)

Salford, M6 8HD, United Kingdom

Location

Sheffield Hospitals NHS Foundation Trust (104)

Sheffield, S10 2SB, United Kingdom

Location

Somerset NHS Foundation Trust (109)

Taunton, TA1 5DA, United Kingdom

Location

Walsall Healthcare NHS Trust (113)

Walsall, WS2 9PS, United Kingdom

Location

Related Publications (2)

• Chorlton J, Hollowood Z, Dyer C, Lockhart D, Boekman P, McCafferty K, Coffey P, Marelli-Berg F, Martin J. A randomised, double-blind, placebo-controlled, multicentre clinical trial of AZD1656 in diabetic patients hospitalised with COVID-19: The ARCADIA Trial - implications for therapeutic immune modulation. EClinicalMedicine. 2022 Sep;51:101604. doi: 10.1016/j.eclinm.2022.101604. Epub 2022 Aug 18.

  PMID: 35996565 DERIVED

• McCafferty K, Hollowood Z, Allen M, Lockhart D, Chorlton J, Martin J. ARCADIA study protocol: a phase II, randomised, double-blind, placebo-controlled clinical trial to assess the safety and efficacy of AZD1656 in patients with diabetes hospitalised with suspected or confirmed COVID-19. BMJ Open. 2021 Dec 1;11(12):e049650. doi: 10.1136/bmjopen-2021-049650.

  PMID: 34853102 DERIVED

MeSH Terms

Conditions

COVID-19; Diabetes Mellitus; Maturity-Onset Diabetes of the Young, Type 2

Interventions

AZD1656

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Mike Johnson, Managing Director
• Organization: St George Street Capital

mike@sgscapital.org

+447768335460

Study Officials

• Kieran McCafferty, MD

  Barts & The London NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 14, 2020
• First Posted: August 18, 2020
• Study Start: August 12, 2020
• Primary Completion: April 25, 2021
• Study Completion: May 12, 2021
• Last Updated: April 25, 2022
• Results First Posted: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Requests for access to the data will be accepted beginning 6 months after article publication and will continue to be accepted for up to 5 years after publication.
• Access Criteria: Researchers must submit a methodologically sound research proposal to St George Street using the contact details provided on our website. See link below.

Locations

GB (15); CZ (7); RO (8)