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    The EU Clinical Trials Register currently displays   38527   clinical trials with a EudraCT protocol, of which   6331   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2020-001740-26
    Sponsor's Protocol Code Number:ATOMIC2
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    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 number2020-001740-26
    A.3Full title of the trial
    A multi-centre open-label two-arm randomised superiority clinical trial of Azithromycin versus usual care In Ambulatory COVID-19 (ATOMIC2)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of an antibiotic called Azithromycin for those who come to hospital with COVID-19 symptoms who are not admitted to hospital (otherwise known as Ambulatory COVID-19) – ATOMIC2
    A.3.2Name or abbreviated title of the trial where available
    ATOMIC2, Version 1.0
    A.4.1Sponsor's protocol code numberATOMIC2
    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 SponsorUniversity of Oxford, Clinical Trials and Research Governance
    B.1.3.4CountryUnited Kingdom
    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 supportPfizer UK
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportUniversity of Oxford
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Oxford
    B.5.2Functional name of contact pointOCTRU
    B.5.3 Address:
    B.5.3.1Street AddressBotnar Research Centre
    B.5.3.2Town/ cityWindmill Road
    B.5.3.3Post codeOX3 7LF
    B.5.4Telephone number01865223469
    B.5.6E-mailoctrutrialshub@ndorms.ox.ac.uk
    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 Yes
    D.2.1.1.1Trade name Zithromax
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameZithromax
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAzithromycin dihydrate
    D.3.9.1CAS number 117772-70-0
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    COVID-19
    E.1.1.1Medical condition in easily understood language
    Coronavirus
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10070255
    E.1.2Term Coronavirus test positive
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Can a course of antibiotics reduce the number of people with COVID-19 symptoms who go to hospital but who doctors decide do not need to be admitted from getting worse?
    (There is where worse is considered being admitted to hospital or dying).

    Another more scientific way of describing this is:
    Does giving patients who have a clinical diagnosis of COVID-19 who go to hospital with their symptoms, but who doctors decide to not need to be admitted and and are sent home, does giving these patients 14 days of an antibiotic called Azithromycin result in reducing the number of patients who then either die or get admitted to hospital with respiratory failure requiring help with their breathing either by Non-Invasive Mechanical Ventilation (NIV) or Invasive Mechanical Ventilation (IMV) in the period of 28 days from randomisation.
    E.2.2Secondary objectives of the trial
    -Are there differences in those that die in each group in the trial
    -Are there differences in those that die or are admitted to hospital for help with their breathing (when those that take part are split into those that a test called a PCR confirms that the patient does indeed have COVID-19 or not
    - Are there differences in those that progress to having pneumonia in each group
    - Are there differences in those that progress to have severe pneumonia in each group
    - Are there differences in the peak severity of illness scores in each group
    - Are these differences in the number of severe adverse events in each group
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or Female, aged at least 18 years
    • Assessed as appropriate for initial ambulatory (outpatient) management
    • A clinical diagnosis of highly-probable COVID-19 infection
    • No medical history that might, in the opinion of the attending clinician, put the patient at significant risk if he/she were to participate in the trial
    • Able to understand written English (for the information and consent process) and be able to give informed consent

    E.4Principal exclusion criteria
    • Known hypersensitivity to any Macrolide including Azithromycin, ketolide antibiotic, or the excipients including an allergy to soya or peanuts.
    • Known fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase-insufficiency
    • Currently on a Macrolide antibiotic (Clarithromycin, Azithromycin, Erythromycin, Telithromycin, Spiramycin)
    • On any SSRI (Selective Serotonin Reuptake Inhibitor)
    • Elevated cardiac troponin at initial assessment suggestive of significant myocarditis (if clinically the clinical team have felt it appropriate to check the patient’s troponin levels)
    • Evidence of QTc prolongation: QTc>480ms
    • Significant electrolyte disturbance (e.g. hypokalaemia K+<3.5 mmol/L)
    • Clinically relevant bradycardia (P<50 bpm), non-sustained ventricular tachycardia or unstable severe cardiac insufficiency
    • Currently on hydroxychloroquine or chloroquine
    E.5 End points
    E.5.1Primary end point(s)
    To compare the effect of Azithromycin in participants with a clinical diagnosis of COVID-19 in reducing the proportion with either death or hospital admission with respiratory failure requiring Non-Invasive Mechanical Ventilation (NIV) or Invasive Mechanical Ventilation (IMV) over the 28 days from randomisation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days after randomisation
    E.5.2Secondary end point(s)
    To compare the effect of Azithromycin in participants with a PCR-confirmed diagnosis of COVID-19 in reducing the proportion with either death or hospital admission with respiratory failure requiring invasive or non-invasive mechanical ventilation over 28 days from randomisation.

    To compare differences in all-cause mortality.

    To compare differences in pneumonia.

    To compare differences in proportion progressing to severe pneumonia.

    To compare differences in peak severity of illness.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 28 days after randomisation
    (Hospital stay may be after 28 days if the incidence is not contained with 28 days of randomisation)
    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 No
    E.6.5Efficacy No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    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 concerned10
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA10
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    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 trial will be when all samples taken have been analysed and all the data has been entered into the clinical database and all queries have been resolved.
    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 months11
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days31
    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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 400
    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 state800
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 800
    F.4.2.2In the whole clinical trial 800
    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)
    There is no provision of antibiotics after the study period. It will take until the end of the study to know what the answer to the question is.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation N/A
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-05-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-05
    P. End of Trial
    P.End of Trial StatusOngoing
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