Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   42869   clinical trials with a EudraCT protocol, of which   7063   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    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

    Summary
    EudraCT number
    2020-002211-21
    Trial protocol
    GB   CZ   RO  
    Global end of trial date
    12 May 2021

    Results information
    Results version number
    v1(current)
    This version publication date
    12 Feb 2022
    First version publication date
    12 Feb 2022
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    SGS.1656.201
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04516759
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    St George Street Capital
    Sponsor organisation address
    2a/2b Thrales End Business Centre, Thrales End Lane , Harpenden, United Kingdom, AL5 3NS
    Public contact
    Clinical Trials, St George Street Capital Ltd, +44 7901119230, info@sgscapital.org
    Scientific contact
    Clinical Trials, St George Street Capital Ltd, +44 7901119230, info@sgscapital.org
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    06 Dec 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 May 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    12 May 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    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.
    Protection of trial subjects
    The investigator or one of their associates informed the patients of the risks and benefits of the study. The patients were informed that they could withdraw from the study at any time for any reason. Consent was obtained in writing prior to any study-related activities; the investigator retained the ICFs, which were available to the Sponsor for inspection, and a copy of the signed consent form was provided to the patient.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    29 Sep 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Romania: 33
    Country: Number of subjects enrolled
    United Kingdom: 71
    Country: Number of subjects enrolled
    Czechia: 49
    Worldwide total number of subjects
    153
    EEA total number of subjects
    82
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    69
    From 65 to 84 years
    82
    85 years and over
    2

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    It is noted that 3 more subjects were randomised, however, these subjects were never exposed to study drug and have not been included in this record.

    Pre-assignment
    Screening details
    Patients underwent a Screening Visit (V1) and Randomisation Visit (V2) to evaluate their eligibility to participate in the study and to commence study treatment (Day 1).

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Patients receiving standard care plus placebo
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients received 2 x tablets twice a day with food.

    Arm title
    AZD1656
    Arm description
    Patients receiving standard of care plus AZD1656.
    Arm type
    Experimental

    Investigational medicinal product name
    AZD1656
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients received 2 x 50 mg tablets twice a day with food.

    Number of subjects in period 1
    Placebo AZD1656
    Started
    73
    80
    Completed
    61
    70
    Not completed
    12
    10
         Reason not stated
    11
    10
         Consent withdrawn by subject
    1
    -

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Patients receiving standard care plus placebo

    Reporting group title
    AZD1656
    Reporting group description
    Patients receiving standard of care plus AZD1656.

    Reporting group values
    Placebo AZD1656 Total
    Number of subjects
    73 80 153
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    31 38 69
        From 65-84 years
    41 41 82
        85 years and over
    1 1 2
    Gender categorical
    Units: Subjects
        Female
    26 30 56
        Male
    47 50 97

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Patients receiving standard care plus placebo

    Reporting group title
    AZD1656
    Reporting group description
    Patients receiving standard of care plus AZD1656.

    Primary: Clinical improvement at Day 14

    Close Top of page
    End point title
    Clinical improvement at Day 14
    End point description
    Number of patients with clinical improvement based on categories 1-3 of the WHO OSCI rating at Day 14.
    End point type
    Primary
    End point timeframe
    Assessment at Day 14
    End point values
    Placebo AZD1656
    Number of subjects analysed
    73
    80
    Units: Number of patients
        Treatment responder
    51
    61
        Treatment failure
    21
    18
        Missing
    1
    1
    Statistical analysis title
    Comparison of AZD1656 vs placebo
    Comparison groups
    Placebo v AZD1656
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.1854
    Method
    Chi-squared
    Parameter type
    Risk ratio (RR)
    Point estimate
    1.09
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.9
         upper limit
    1.32

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    All AEs, including SAEs, were captured after signing the informed consent and until 7 days after treatment discontinuation.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Patients receiving standard care plus placebo

    Reporting group title
    AZD1656
    Reporting group description
    Patients receiving standard of care plus AZD1656.

    Serious adverse events
    Placebo AZD1656
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 69 (20.29%)
    8 / 84 (9.52%)
         number of deaths (all causes)
    9
    4
         number of deaths resulting from adverse events
    9
    4
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    2 / 69 (2.90%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Circulatory collapse
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac disorders
    Angina unstable
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicide attempt
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Pancreatitis acute
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Acute hepatic failure
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypophagia
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abscess limb
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    5 / 69 (7.25%)
    2 / 84 (2.38%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    COVID-19 pneumonia
         subjects affected / exposed
    2 / 69 (2.90%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Placebo AZD1656
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 69 (18.84%)
    28 / 84 (33.33%)
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Blood glucose decreased
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Vitamin D decreased
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 69 (0.00%)
    2 / 84 (2.38%)
         occurrences all number
    0
    2
    Atrial flutter
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 69 (2.90%)
    0 / 84 (0.00%)
         occurrences all number
    2
    0
    Leukocytosis
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Neutrophilia
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Thrombocytopenia
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    3 / 69 (4.35%)
    4 / 84 (4.76%)
         occurrences all number
    3
    4
    Hiccups
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Reversible ischaemic neurological deficit
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Restlessness
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 69 (0.00%)
    2 / 84 (2.38%)
         occurrences all number
    0
    2
    Abdominal tenderness
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Constipation
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Dysuria
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Urinary retention
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    Hepatitis toxic
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    1 / 69 (1.45%)
    8 / 84 (9.52%)
         occurrences all number
    1
    13
    Hyperglycaemia
         subjects affected / exposed
    1 / 69 (1.45%)
    4 / 84 (4.76%)
         occurrences all number
    1
    4
    Hypokalaemia
         subjects affected / exposed
    0 / 69 (0.00%)
    4 / 84 (4.76%)
         occurrences all number
    0
    4
    Hyperkalaemia
         subjects affected / exposed
    0 / 69 (0.00%)
    2 / 84 (2.38%)
         occurrences all number
    0
    2
    Infections and infestations
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Oral candidiasis
         subjects affected / exposed
    1 / 69 (1.45%)
    1 / 84 (1.19%)
         occurrences all number
    1
    1
    Sepsis
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Cystitis
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Device related infection
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Oral fungal infection
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    1
    Vulvovaginal mycotic infection
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Dec 2020
    Amendment 1, Version 1.1 (Czech Republic) - Modification of inclusion criteria: > Patients must be aged between 18 and 75 years inclusive. Patients older than 75 years were not eligible in contrast to the UK and Romania. > Patients must have confirmed COVID-19 at enrolment or within 48 hours of screening. Patients with suspected COVID-19 were not eligible in contrast to the UK and Romania. - Addition of an assessment of the clinical condition of all the patients 28 days (+/- 2 days) following the completion of study treatment as an onsite visit for patients still hospitalised or as a phone call for discharged patients. - Additional requirements for glycaemic control added. - Additional details on SARS-CoV-2 PCR testing for eligibility added
    17 Dec 2020
    Amendment 2, Version 1.2 (Romania) - A serum pregnancy test was added as requirement at baseline. - Additional requirements for glycaemic control added.
    21 Dec 2020
    Amendment 3, Version 2.0 (Global) -Clarified that treatment was to be administered for a maximum of 21 days. - Clarified that only out of range and clinically significant data of repeated ECG, clinical laboratory, cardiac biomarker, and SARS-CoV-2 PCR testing were to be recorded. It is noted that protocol version 2.0, identified as 'global', was only submitted in the UK and did not contain the local changes implemented in versions 1.1 and 1.2. Changes in version 2.0 were implemented in the applicable local versions 2.1 and 2.2.
    13 Jan 2021
    Amendment 4, Version 2.1 (Czech Republic) - Clarified that treatment was to be administered for a maximum of 21 days. - Clarified that only out of range and clinically significant data of repeated ECG, clinical laboratory, cardiac biomarker, and SARS-CoV-2 PCR testing were to be recorded.
    13 Jan 2021
    Amendment 5, Version 2.2 (Romania) - Clarified that treatment was to be administered for a maximum of 21 days. - Clarified that only out of range and clinically significant data of repeated ECG, clinical laboratory, cardiac biomarker, and SARS-CoV-2 PCR testing were to be recorded.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    It is noted that per protocol, progression of disease (COVID-19) was not required to be reported as an adverse event. However all sites reported fatalities due to COVID-19 as AEs and these have been included in the SAEs presented here.
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA