Covid19Phase 2ARCADIANCT04516759
AZD1656 in Diabetic Patients Hospitalised With Suspected or Confirmed COVID-19
A Phase 2 study testing AZD1656 in people with Covid19, run by St George Street Capital at 30 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- AZD1656
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 30 sitesin 3 countries
- Study dates
- 12 Aug 2020to 12 May 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
30 sites in 3 countries.
30 sites in 3 countries
United Kingdom15 sites
Barnsley Hospital NHS Foundation Trust (105)
Barnsley
Bolton NHS Foundation Trust (122)
Bolton
Bradford Teaching Hospitals NHS Foundation Trust (103)
Bradford, BD9 6RJ
North Bristol NHS Trust (116)
Bristol, BS10 5NB
County Durham and Darlington NHS Foundation Trust (121)
Darlington
The Dudley Group NHS Foundation Trust (107)
Dudley, DY1 2HQ
Medway NHS Foundation Trust (108)
Gillingham, ME7 5NY
Hull & East Yorkshire NHS Trust (102)
Hull
Barts Health NHS Trust (101 and 111)
London, E1 1FR
Royal Free London NHS Foundation Trust (119)
London, NW3 2QG
St George's University Hospitals NHS Foundation Trust (114)
London
Penine Acute Hospitals NHS Trust (106)
Salford, M6 8HD
Sheffield Hospitals NHS Foundation Trust (104)
Sheffield, S10 2SB
Somerset NHS Foundation Trust (109)
Taunton, TA1 5DA
Walsall Healthcare NHS Trust (113)
Walsall, WS2 9PS
Romania8 sites
Colentina Clinical Hospital (204)
Bucharest
Spitalul Clinic de Boli Infectioase Cluj-Napoca (203)
Cluj-Napoca
Spitalul Clinic de Pneumoftiziologie "Leon Daniello" Cluj-Napoca (202)
Cluj-Napoca
Spitalul Clinic de Boli Infectioase Constanţa (207)
Constanța
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr Victor Babes Craiova (206)
Craiova
Spitalul Judetean de Urgenta Deva (208)
Deva
Spitalul Clinic de Boli Infectioase "Sfanta Parascheva" Iaşi (205)
Iași
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr Victor Babes Timişoara (201)
Timișoara
Czechia7 sites
Masarykova Univerzita - Fakultni Nemocnice U SV Anny V Brne (308)
Brno
Nemocnice Hořovice (309)
Hořovice
Oblastni Nemocnice Kolín (306)
Kolín
Klaudianova Nemonice (302)
Mladá Boleslav
Fakultni Nemocnice V Motole (303)
Prague
Thomayerova Nemonice (310)
Prague
Nemocnice Třebíč (305)
Třebíč
About this study
Official title: A Phase II, Randomised, Double-blind, Placebo-controlled Clinical Trial to Assess the Safety and Efficacy of AZD1656 in Diabetic Patients Hospitalised With Suspected or Confirmed COVID-19
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.
Read the 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; hexokinase 4) activator which has been shown to reduce blood glucose for up to 4 months in humans. Diabetic patients admitted to hospital with COVID-19 often present with hyperglycaemia and are particularly vulnerable to progression to severe COVID-19. Treatment with AZD1656 (in addition to their usual care) may provide additional glucose control which could help improve clinical outcomes in both Type 1 and Type 2 diabetic populations.
In addition to its glucose lowering effect, AZD1656 may have additional benefits to COVID-19 patients via its effects on immune function. In many patients with severe COVID-19, an overreaction of the body's own immune system can cause severe problems including damage to the lungs and heart, which can lead to breathing problems necessitating intubation and ventilation. AZD1656 has been shown to activate the migration of T regulatory cells to sites of inflammation in preclinical experiments. This migration of Treg cells to inflamed tissue is crucial for their immune-modulatory function (Kishore et al (2017)). AZD1656 could enhance Treg migratory capacity and may prevent the development of cardiorespiratory complications observed in hospitalised patients with COVID-19, leading to lower requirements for oxygen therapy and assisted ventilation, and reduced incidences of pneumonia and acute respiratory distress syndrome (ARDS).
Diabetic patients hospitalised with COVID-19 will be randomised to receive either AZD1656 tablets or placebo tablets on a 1:1 basis until they are discharged from hospital or until they require intubation/mechanical ventilation. The aim of the study is to determine whether AZD1656 improves clinical outcomes in diabetic patients hospitalised with COVID-19. The World Health Organization (WHO) 8-point Ordinal Scale for Clinical Improvement will be used as the standard methodology for measuring patient outcomes.
- Conditions
- Covid19
- Being tested
- AZD1656, Placebo
- Keywords
- COVID-19, Diabetes Mellitus, SARS-CoV-2, Regulatory T Cell, Glucokinase
- Medical subject headings
- COVID-19, Diabetes Mellitus, Maturity-Onset Diabetes of the Young, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1656Drug
50mg film-coated tablets (at daily dose of 100mg BID)
PlaceboOther
Matched placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| AZD1656 (plus Usual Hospital Care) | Experimental | 50mg film-coated tablets at a dose of 100mg BID Receives: Drug: AZD1656 |
| Matched Placebo (plus Usual Hospital Care) | Placebo comparator | Matched placebo tablets Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 to Day 14
Secondary outcomes (7)
Clinical Improvement at Day 7, 14 and 21
The World Health Organization (WHO) 8-point Ordinal Scale for Clinical Improvement (OSCI) was used to measure Clinical Improvement at Day 7, Day 14 and Day 21 versus baseline, comparing AZD1656 treatment with placebo.
Results are presented as the percentage of patients categorised at each severity rating at each timepoint on the WHO 8-point OSCI scale.
The WHO OSCI score ranges from 0-8 (0 = no symptoms, 8 = death). The higher the score the worse the condition of the patient.
Study Drug Discontinuation was the date on which a patient discontinued treatment. Treatment was given for a maximum of 21 days, or until date of hospital discharge (WHO score 1 or 2), or date mechanical ventilation was required (WHO score 6 or 7) or until date of death (WHO score 8).
Measured: Day 1 to Day 21
Glycaemic Control
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
Measured: Day 1 to Day 21
Occurrence of Adverse Events
Proportion of Treatment Emergent Adverse Events (TEAEs) leading to study drug discontinuation in patients receiving AZD1656 compared with placebo
Measured: Day 1 to Day 28
Occurrence of Serious Adverse Events
Proportion of Serious Adverse Events (SAEs) in patients receiving AZD1656 compared with placebo
Measured: Day 1 to Day 28
Duration of Hospitalisation
Time from hospital admission to hospital discharge (in hours) in patients receiving AZD1656 compared with placebo
Measured: Day 1 to Day 21
Mortality Rate
Mortality rate in patients receiving AZD1656 compared with placebo.
Measured: Day 1 to Day 28
Intubation/Mechanical Ventilation
Number of Patients Receiving Intubation/Mechanical Ventilation
Measured: Day 1 to Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start12 Aug 2020
- Primary completion25 Apr 2021
- Study completion12 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- St George Street Capital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kieran McCafferty, MD, Principal investigator, Barts & The London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516759
- Sponsor's protocol ID
- SGS.1656.201
- Other IDs
- 2020-002211-21
- Acronym
- ARCADIA
- Status last verified
- Apr 2022
- First submitted
- 14 Aug 2020
- Last updated
- 25 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to deidentified individual participant data (IDP) that underlie the published clinical trial results.
Publications
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.
PubMed 35996565McCafferty 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.
PubMed 34853102
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomised, Double-blind, Placebo-controlled Clinical Trial to Assess the Safety and Efficacy of AZD1656 in Diabetic Patients Hospitalised With Suspected or Confirmed COVID-19
- ClinicalTrials.gov ID
- NCT04516759
- Acronym / sponsor ID
- ARCADIA / SGS.1656.201
- Conditions
- Covid19
- Keywords
- COVID-19, Diabetes Mellitus, SARS-CoV-2, Regulatory T Cell, Glucokinase
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- St George Street CapitalUniversity, hospital or other
- Study start
- 12 Aug 2020 (actual)
- Primary completion
- 25 Apr 2021 (actual)
- Study completion
- 12 May 2021 (actual)
- First posted
- 18 Aug 2020 (actual)
- Results
- Posted 25 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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; hexokinase 4) activator which has been shown to reduce blood glucose for up to 4 months in humans. Diabetic patients admitted to hospital with COVID-19 often present with hyperglycaemia and are particularly vulnerable to progression to severe COVID-19. Treatment with AZD1656 (in addition to their usual care) may provide additional glucose control which could help improve clinical outcomes in both Type 1 and Type 2 diabetic populations.
In addition to its glucose lowering effect, AZD1656 may have additional benefits to COVID-19 patients via its effects on immune function. In many patients with severe COVID-19, an overreaction of the body's own immune system can cause severe problems including damage to the lungs and heart, which can lead to breathing problems necessitating intubation and ventilation. AZD1656 has been shown to activate the migration of T regulatory cells to sites of inflammation in preclinical experiments. This migration of Treg cells to inflamed tissue is crucial for their immune-modulatory function (Kishore et al (2017)). AZD1656 could enhance Treg migratory capacity and may prevent the development of cardiorespiratory complications observed in hospitalised patients with COVID-19, leading to lower requirements for oxygen therapy and assisted ventilation, and reduced incidences of pneumonia and acute respiratory distress syndrome (ARDS).
Diabetic patients hospitalised with COVID-19 will be randomised to receive either AZD1656 tablets or placebo tablets on a 1:1 basis until they are discharged from hospital or until they require intubation/mechanical ventilation. The aim of the study is to determine whether AZD1656 improves clinical outcomes in diabetic patients hospitalised with COVID-19. The World Health Organization (WHO) 8-point Ordinal Scale for Clinical Improvement will be used as the standard methodology for measuring patient outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| AZD1656 (plus Usual Hospital Care) | Experimental | Drug: AZD165650mg film-coated tablets at a dose of 100mg BID |
| Matched Placebo (plus Usual Hospital Care) | Placebo comparator | Other: PlaceboMatched placebo tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD165650mg film-coated tablets (at daily dose of 100mg BID) | Drug | AZD1656 (plus Usual Hospital Care) |
| PlaceboMatched placebo tablets | Other | Matched Placebo (plus Usual Hospital Care) |
Primary outcome
Clinical Improvement by Day 14
Time frame: Day 1 to 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.
7 secondary outcomes
Clinical Improvement at Day 7, 14 and 21
Time frame: Day 1 to Day 21
Glycaemic Control
Time frame: Day 1 to Day 21
Occurrence of Adverse Events
Time frame: Day 1 to Day 28
Occurrence of Serious Adverse Events
Time frame: Day 1 to Day 28
Duration of Hospitalisation
Time frame: Day 1 to Day 21
Mortality Rate
Time frame: Day 1 to Day 28
Intubation/Mechanical Ventilation
Time frame: Day 1 to Day 21
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35996565Chorlton 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.
- Derived from this study: PubMed 34853102McCafferty 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.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to deidentified individual participant data (IDP) that underlie the published clinical trial results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kieran McCafferty, MD principal investigator
Barts & The London NHS Trust
30 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD1656 in people with Covid19, run by St George Street Capital at 30 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United Kingdom, Romania, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Improvement by Day 14 (time frame: Day 1 to Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04516759, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.