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    Summary
    EudraCT Number:2020-001402-38
    Sponsor's Protocol Code Number:CTU/2020/352
    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:2020-05-20
    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 number2020-001402-38
    A.3Full title of the trial
    An international, Bayesian platform adaptive, randomized, placebo-controlled trial assessing the effectiveness of candidate interventions in preventing COVID-19 disease in healthcare workers.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CROWN CORONATION: COVID-19 Research Outcomes Worldwide Network for CORONAvirus prevenTION
    A.3.2Name or abbreviated title of the trial where available
    CROWN CORONATION
    A.4.1Sponsor's protocol code numberCTU/2020/352
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN99916292
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04333732
    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 College London
    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 supportCOVID-19 Therapeutics Accelerator
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationComprehensive Clinical Trials unit at UCL
    B.5.2Functional name of contact pointGemma Jones
    B.5.3 Address:
    B.5.3.1Street AddressCCTU at UCL, Institute of Clinical Trials & Methodology
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeWC1V 6LJ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02031086833
    B.5.6E-mailcctu.ccoronation@ucl.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 MMRVAXPRO
    D.2.1.1.2Name of the Marketing Authorisation holderMSD VACCINS
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameMMRVAXPRO
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMeasles virus
    D.3.9.4EV Substance CodeAS4
    D.3.10 Strength
    D.3.10.1Concentration unit CCID50 cell culture infective dose 50
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number1 x 10 to power 3
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMumps virus
    D.3.9.4EV Substance CodeAS5
    D.3.10 Strength
    D.3.10.1Concentration unit CCID50 cell culture infective dose 50
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number12.5 x 10 power 3
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRubella virus
    D.3.9.4EV Substance CodeAS6
    D.3.10 Strength
    D.3.10.1Concentration unit CCID50 cell culture infective dose 50
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number1 x 10 to power 3
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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) Yes
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Coronavirus disease 2019 (COVID-19), also known as SARS-CoV-2 infection
    E.1.1.1Medical condition in easily understood language
    Novel Coronavirus 2019 infection
    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 10084268
    E.1.2Term COVID-19
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective:
    To determine the effectiveness of the active arm(s) in preventing symptomatic (i.e. any of the following: cough, shortness of breath or difficulty breathing, fever, chills, muscle pain, sore throat, new loss of taste or smell, nausea, vomiting, or diarrhea), laboratory test-confirmed COVID-19 in healthcare workers with repeated exposures to SARS-CoV-2 by day 60 after receiving treatment intervention.
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    1. To determine the effectiveness of the treatment arm(s) in mitigating the severity of COVID-19 in healthcare workers who become infected with SARS-CoV-2 by day 60 after receiving trial intervention. Severity will be graded on a simplified Ordinal WHO COVID-19 severity scale.

    2. To determine the effectiveness of the trial interventions in preventing/reducing the incidence of SARS-CoV-2 infection (by serology) over up to 5 months of follow-up.
    E.2.3Trial contains a sub-study No
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: Hydroxychloroquine to reduce the likelihood of
    developing COVID-19 in non-healthcare workers.
    Version: 2.0
    Date: 12 May 2020
    The aims of this sub-study are to determine if the following endpoints in exposed factor workers who are not following recommended social distancing are effective.

    Primary endpoint 1:
    If hydroxychloroquine is effective at preventing COVID-19 (a WHO score 1 or above).

    Secondary endpoint:
    The minimum effective dosing schedule of hydrochloroquine for preventing COVID-19 and/or mitigating severity in onset of the disease.

    The study design will be identical to the main study. The differences are that this sub-study is taking place only in UK factory workers at two sites and that the primary endpoint will be diagnosis of COVID-19, whether symptomatic or not.
    E.3Principal inclusion criteria
    1.Volunteers without clinical evidence of COVID-19 infection aged 18 years and older.
    2.Healthcare workers based in a primary, secondary or tertiary healthcare settings with a high risk of developing COVID-19 due to their potential exposure to patients with SARS-CoV-2 infection.
    3.The participant must have a mobile phone and access to the Internet for data collection purposes.
    4.Participants who are willing and able to provide informed consent via an electronic consent process.
    E.4Principal exclusion criteria
    1.Weight outside range 50 kg – 120 kg (110 lbs – 265 lbs).
    2.Prior enrolment into other COVID-19 interventional prevention or treatment trials (observational trials not excluded).
    3.Self-reported or diagnosed current infection with SARS-CoV-2 or previous COVID-19 diagnosis.
    4.Self-reported current acute respiratory infection.
    5.Concurrent and/or recent involvement in other research or use of the investigational product/s, a product considered to be equivalent to the investigational product/s, or any other product that is likely to interfere with the investigational products in this trial used within three months of study enrolment.
    6.Self-reported known allergies to any of the IMPs and excipients of the IMPs and placebo.
    7.Self-reported presence or history of the conditions listed in the appendix relevant to that IMP
    8.Self-reported current use of medication with known to interact with any of the medications listed in the appendices.
    9.Inability or unwillingness to be followed up for the trial period

    The following additional exclusion criteria, listed in the appendices, are applicable to the MMR intervention arm:
    1. pregnant women
    2. Individuals receiving high dose corticosteroids, other immuno-suppressive drugs, alkylating agents or anti-metabolites
    3. individuals undergoing radiotherapy
    4. any malignant disease either untreated or currently undergoing therapy
    5. History of administration of gammaglobulin or blood transfusions within the previous 3 months.
    6. Participants with an allergy to the MR (MMR) vaccine or its components, including neomycin.
    7. Idiopathic thrombocytopenic purpura (ITP)
    8. Untreated tuberculosis
    9. Prior receipt of any vaccines (licensed or investigational) ≤30 days before enrollment
    10. Planned receipt of a live attenuated vaccine [e.g. oral polio vaccine, inhaled influenza vaccine, BCG] or a vaccine for SARS-CoV-2 within 30 days after the study vaccination. Planned receipt of an inactivated influenza vaccine (via injection) is not an exclusion criterion
    11. Prior receipt of an investigational or licensed vaccine likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus vaccines).
    12. Any confirmed or suspected immunosuppressive or immunodeficient state, including untreated HIV infection with a CD4T count <200 /mL
    13. Asplenia

    As new arms are added new eligibility criteria will be listed in the appendices.
    E.5 End points
    E.5.1Primary end point(s)
    Symptomatic COVID-19: Clinical diagnosis of COVID-19 with laboratory confirmation (i.e. based on viral PCR), and symptoms of COVID-19 (cough, shortness of breath or difficulty breathing, fever, chills, muscle pain, sore throat, new loss of taste or smell, nausea, vomiting, or diarrhea) by day 60 after receiving treatment intervention.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The final analysis of the primary endpoint will take place once all study participants have reached their primary endpoint 60 days after commencement of trial intervention.

    In addition, this Bayesian trial will perform frequent interim analyses for efficacy, futility and harm. This means that the DMC will regularly consider the balance of benefit and risk. Strong evidence of benefit, futility, or harm will result in the advice to modify or stop the trial.
    E.5.2Secondary end point(s)
    Secondary endpoint of special interest:
    Severity of COVID-19 over the study period using the WHO scoring system 0 to 8 where 0 is uninfected and 8 is death.

    Secondary endpoints:
    ● Primary endpoint, but instead of the 60-day time-window, over the course of the first 30 days of treatment
    ● Symptomatic COVID-19 (with subsequent virological confirmation) during the 5-month study period.
    ● Incident COVID-19 during the 60-day study period, which includes asymptomatic infections identified by serology samples taken at the time-point of study exit.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary outcomes will be evaluated at interim analyses and at the end of the trial once the recruitment and follow-up period has completed and all the data from the last participants last visit has been received.

    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    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 No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Placebo controlled
    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 concerned30
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Ireland
    United Kingdom
    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 the trial is defined as five months after the last participant is enrolled when the database is locked, and all queries are resolved.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 3420
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 180
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state3600
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 4500
    F.4.2.2In the whole clinical trial 30000
    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)
    The trial intervention is being given to healthy volunteers to determine the effectiveness of the trial intervention(s) in preventing symptomatic COVID-19. It is not being used as a treatment for a medical condition. The participants will only receive 1 dose (MMR/placebo) at the time of enrolment. There are no arrangements being made for continued provision of the trial intervention after participation is completed.
    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 CRN North Thames
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-30
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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    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.

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