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 were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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 on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    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

    Print Download

    Summary
    EudraCT Number:2020-001473-79
    Sponsor's Protocol Code Number:ESR-20-20653
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-04-24
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2020-001473-79
    A.3Full title of the trial
    An International, Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Dapagliflozin in Respiratory Failure in Patients with COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dapagliflozin in Respiratory failure in patients with COVID-19
    A.3.2Name or abbreviated title of the trial where available
    Dapagliflozin in Respiratory failure in patients with COVID-19
    A.4.1Sponsor's protocol code numberESR-20-20653
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04350593
    A.5.4Other Identifiers
    Name:INDNumber:149478
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSaint Luke’s Hospital of Kansas City, Kansas City, Missouri, USA
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAstraZeneca
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGeorge Clinical (UK) Limited
    B.5.2Functional name of contact pointAndrejs Faibusevics
    B.5.3 Address:
    B.5.3.1Street Address9 Dallington St.
    B.5.3.2Town/ cityClerkenwell, London
    B.5.3.3Post codeEC1V 0LN
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+37129235028
    B.5.5Fax number+447776511 778
    B.5.6E-mailafaibusevics@georgeclinical.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDapagliflozin
    D.3.2Product code A10BK01
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasogastric use (Noncurrent)
    Oral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDapagliflozin
    D.3.9.1CAS number 461432-26-8
    D.3.9.2Current sponsor codeBMS-512148-05
    D.3.9.3Other descriptive nameDAPAGLIFLOZIN
    D.3.9.4EV Substance CodeSUB31650
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Respiratory Failure in patients with COVID-19
    E.1.1.1Medical condition in easily understood language
    Respiratory Failure
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether dapagliflozin 10 mg is superior to placebo, in reducing disease progression, complications, and all-cause mortality in patients hospitalized with COVID-19.
    E.2.2Secondary objectives of the trial
    To evaluate the net clinical benefit of dapagliflozin 10 mg compared to placebo in patients hospitalized with COVID 19
    To compare the effect of dapagliflozin 10 mg versus placebo on time to hospital discharge
    To compare the effect of dapagliflozin 10 mg versus placebo on total number of days alive, out of hospital, and/or free from mechanical ventilation
    To compare the effect of dapagliflozin 10 mg versus placebo on total number of days alive, not in ICU, and/or free from mechanical ventilation
    To compare the effect of dapagliflozin 10 mg versus placebo in reducing the incidence of all cause mortality
    To compare the effect of dapagliflozin 10 mg versus placebo in reducing new or worsened organ dysfunction
    To compare the effect of dapagliflozin 10 mg versus placebo on acute kidney injury
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For inclusion in the study patients should fulfil the following criteria based on local regulations:
    1 Provision of informed consent prior to any study specific procedures. The ICF process is described in Section 10.4
    2 Male or female patients aged ≥18 years on the day consent given
    3 Currently hospitalized
    4 Confirmed SARS-CoV-2 infection by laboratory testing <72h prior to randomization or strongly suspected on presentation
    5 Chest radiography or CT findings consistent with COVID-19, defined as: chest X-ray and/or CT scan demonstrating ground glass and/or fine reticular opacities with or without crazy-paving, multifocal organizing pneumonia and architectural distortion in a predominantly peripheral distribution
    6 Mild-moderate disease: SpO2≥94% with low-flow supplemental oxygen (3 liters or less)
    7 Medical history of at least one of the following:
    (a) hypertension
    (b) T2DM
    (c) atherosclerotic cardiovascular disease
    (d) heart failure (with either reduced or preserved LVEF)
    (e) CKD stage 3 to 4 (eGFR between 25 to 60 mL/min/1.73 m2)
    E.4Principal exclusion criteria
    1 Severe COVID-19: requiring mechanical ventilation via endotracheal intubation, and/or non-invasive ventilation
    2 Expected need for mechanical ventilation with endotracheal intubation, non-invasive ventilation, or continuous positive airway pressure (CPAP) within the next 24 hours
    3 Anticipated transfer to another hospital facility, which is not another study site, within 72 hours
    4 Expected survival of less than 24 hours at the time of presentation, in the judgement of the Investigator
    5 eGFR <25 mL/min/1.73 m2 or receiving renal replacement therapy/dialysis
    6 Evidence of oliguria (urine output <500 mL in 24 hours or <0.5 mL/kg/hour) or serum creatinine ≥1.5x baseline pre-hospitalization value, if available at the time of screening
    7 Systolic BP <95 mmHg and/or requirement for vasopressor treatment and/or inotropic or mechanical circulatory support at Screening
    8 History of type 1 diabetes mellitus
    9 Currently receiving or has received in the last 14 days, experimental immune modulators and/or monoclonal antibody therapies for COVID-19**
    10 History of diabetic ketoacidosis within last 6 months
    11 Current treatment with any SGLT2i (eg, dapagliflozin, canagliflozin, empagliflozin, ertugliflozin) or having received treatment with any SGLT2i within 4 weeks prior to screening
    12 History of hypersensitivity to dapagliflozin
    13 Any other condition that in the judgment of the investigator would jeopardize the patient's participation in the study or that may interfere with the interpretation of study data or if the patient is considered unlikely to comply with study procedures, restrictions and requirements
    14 Women of childbearing potential: Current or planned pregnancy or currently lactating.
    (a) Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or post-menopausal
    (b) Post-menopausal is defined as 12 consecutive months with no menses without an alternative medical cause
    (c) Women of childbearing potential, who are sexually active, must agree to use a medically accepted method of birth control for the duration of the study.
    15 Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site)
    16 Previous enrolment in the present study. (Note: the study design allows 2 attempts to meet the randomization criteria after enrolment.)
    17 Current participation in another interventional clinical trial (with an investigational drug) that is not an observational registry
    E.5 End points
    E.5.1Primary end point(s)
    Time to first occurrence of either death from any cause or new/worsened organ dysfunction through 30 days of follow up, defined as at least one of the following:
    • Respiratory decompensation requiring initiation of invasive or non invasive mechanical ventilation or continuous positive airway pressure (CPAP) treatment, and/or initiation of veno venous extracorporeal membrane oxygenation (ECMO)
    • New or worsening congestive HFa during current hospitalization
    • Requirement for vasopressor therapy and/or inotropic or mechanical circulatory support
    • Ventricular tachycardia or fibrillation lasting at least 30 seconds and/or associated with hemodynamic instability or pulseless electrical activity, or resuscitated cardiac arrest
    • Initiation of renal replacement therapy
    E.5.1.1Timepoint(s) of evaluation of this end point
    A number of efficacy endpoints, listed below, relate to the timing of an event. Patients are reviewed daily for the occurrence of each of these events. The date and time (24 hr) (time if known) of the event will be recorded.
    • Death from any cause
    • New/worsened organ dysfunction (as defined in the primary outcome measure). This will be tested for both definitions of respiratory decompensation
    • Hospital discharge
    • Acute kidney injury (defined as doubling of s Creatinine compared to baseline)
    The NEWS 2 can be used on all hospitalized patients to allow for the early detection of clinical deterioration and potential need for higher level of care. It determines the degree of illness of a patient and prompts critical care intervention.
    E.5.2Secondary end point(s)
    To evaluate the net clinical benefit of dapagliflozin 10 mg compared to placebo in patients hospitalized with COVID 19
    To compare the effect of dapagliflozin 10 mg versus placebo on time to hospital discharge
    To compare the effect of dapagliflozin 10 mg versus placebo on total number of days alive, out of hospital, and/or free from mechanical ventilation
    To compare the effect of dapagliflozin 10 mg versus placebo on total number of days alive, not in ICU, and/or free from mechanical ventilation
    To compare the effect of dapagliflozin 10 mg versus placebo in reducing the incidence of all cause mortality
    To compare the effect of dapagliflozin 10 mg versus placebo in reducing new or worsened organ dysfunction
    To compare the effect of dapagliflozin 10 mg versus placebo on acute kidney injury
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Hierarchical composite outcome measure (1):
    1 Time to death from any cause
    2 Time to new/worsened organ dysfunction (as defined in the primary outcome measure)
    3 Clinical status at Day 30 for patients still hospitalized and without any worsening organ dysfunction (using points 3 to 5 of a 7-point ordinal scalea)
    4 Time to hospital discharge

    • Hierarchical composite outcome measure (2):
    1 Time to death from any cause
    2 Time to new/worsened organ dysfunction (as defined in footnote b)
    3 Clinical status at Day 30 for patients still hospitalized and without any worsening organ dysfunction (using points 3 to 5 of a 7-point ordinal scalea)
    4 Time to hospital discharge
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Italy
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the study is defined as ‘the last visit of the last subject undergoing the study’—also known as LSLV.
    The study is expected to start in second quarter 2020, with LSLV in the third quarter 2020.
    The study may be terminated at individual centers if the study procedures are not being performed according to GCP, or if recruitment is slow. Sponsor may also terminate the entire study prematurely if concerns for safety arise within this study or in any other study with dapagliflozin.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days29
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days22
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 450
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 450
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 450
    F.4.2.2In the whole clinical trial 900
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Not applicable
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-04-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-07
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Mon May 06 03:04:19 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA