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Trial record 2 of 4 for:    MMR | Covid19

CROWN CORONATION: COVID-19 Research Outcomes Worldwide Network for CORONAvirus prevenTION (CROWN CORONA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04333732
Recruitment Status : Recruiting
First Posted : April 3, 2020
Last Update Posted : September 9, 2020
Sponsor:
Collaborator:
COVID -19 Therapeutics Accelerator
Information provided by (Responsible Party):
Michael Avidan, Washington University School of Medicine

Brief Summary:
The objective of CROWN CORONATION is the prevention of symptomatic COVID-19 by using combinations of approved and safe repurposed interventions, with complementary mechanisms of action.

Condition or disease Intervention/treatment Phase
COVID 19 Drug: MR or M-M-R II ® vaccine Drug: Placebo Phase 3

Detailed Description:

CROWN CORONATION is an international, Bayesian platform adaptive, randomized, placebo-controlled trial assessing the effectiveness of candidate interventions in preventing COVID-19 disease in healthcare workers.

Randomization will be stratified by age (<50 and ≥50) and site. Participants will be healthcare workers at risk of contracting SARS-CoV-2. Participants will be randomized into one of two arms:

  • Education and surveillance plus MR or MMR vaccine
  • Education and surveillance plus Placebo

While the initial intervention to be tested on the platform will be the MR or MMR vaccine, other interventions might be added or removed over the course of the trial. The trial will evaluate which of the intervention arms is most effective at decreasing the incidence of symptomatic COVID-19 disease, without unacceptable side effects or safety events.

All participants will require be required to have a mobile phone to participate. This is standard in all the countries in this study. Most, but not all, will also have a smartphone. Participants will complete weekly data logs via SMS texting. Follow-up information will be collected until approximately 5 months after the end of treatment or death. Participants who develop symptomatic COVID-19 during the last month of observation will at a minimum be followed-up until symptom resolution and at a maximum until 6 months after randomization (whichever comes first). Telemedicine approaches to collecting information on participants will be used where possible. The trial will provide adherence support interventions that have been shown in randomized controlled trials to improve adherence to Human Immunodeficiency Virus treatment and adapted for HIV Pre-Exposure Prophylaxis (HIV PrEP) (e.g. two-way SMS with check in for those that report symptoms or adverse events). The database will be hosted on UK-based servers which are expected to be managed by Sealed Envelope Ltd. Local investigators will have access to the part of the CRF to enable recording of outcome data and/or severity of COVID-19 symptoms. Participants will be given a secure login to enable them to complete an initial participant health questionnaire and the regular data logs. It is envisaged that these will be completed at least weekly.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: An international, multi-site, randomized, placebo-controlled, Bayesian platform clinical trial. Initially there will be 2 arms, but we anticipate adding intervention arms to the platform. Combining interventions, allowing assessment of potential interactions, will be considered when arms are added.
Masking: Double (Participant, Investigator)
Masking Description: For the MR or MMR vaccine, there will be a placebo vaccine. Attempts will be made to maintain masking for other interventions (e.g. oral tablets) added to the platform by including suitable placebo options.
Primary Purpose: Prevention
Official Title: An International, Multi-site, Bayesian Platform Adaptive, Randomized, Placebo-controlled Trial Assessing the Effectiveness of Candidate Agents in Mitigating COVID-19 Disease in Healthcare Workers
Actual Study Start Date : September 4, 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: M-M-R II ®
Education and surveillance plus M-M-R II ®
Drug: MR or M-M-R II ® vaccine
Education and surveillance plus MR or M-M-R II ® vaccine
Other Name: Merck

Placebo Comparator: Placebo
Education and surveillance plus placebo
Drug: Placebo
Placebo injection




Primary Outcome Measures :
  1. Symptomatic COVID-19 [ Time Frame: 60 days ]
    To determine the incidence of the trial intervention(s) in preventing laboratory test-confirmed, symptomatic COVID19 (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), in healthcare workers with repeated exposures to SARS-CoV-2 by day 60 after enrollment.


Secondary Outcome Measures :
  1. Severity of COVID-19 over the study period [ Time Frame: 60 days ]
    Severity of COVID-19 will be graded on a simplified version of the ordinal World Health Organization COVID-19 severity scale (WHO COVID-19 severity scale).

  2. Effectiveness of preventing/reducing SARS-CoV-2 infection [ Time Frame: 5 months ]
    SARS-CoV-2 infection (by serology) over up to 5 months of follow-up



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 setting with a high risk of developing COVID-19 due to their potential exposure to patients with SARS-CoV-2 infection.
  3. 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.

Exclusion criteria

  1. Prior enrollment into other COVID-19 interventional prevention or treatment trials (observational trials not excluded).
  2. Self-reported or diagnosed current infection with SARS-CoV-2 or previous COVID-19 diagnosis.
  3. Self-reported current acute respiratory infection.
  4. Concurrent and/or recent involvement in other research or use of the investigational product, a product considered to be equivalent to the investigational product, or any other product that is likely to interfere with the investigational products in this trial used within three months of study enrolment.
  5. Self-reported known allergies to any of the IMPs and excipients of the IMPs and placebo.
  6. Self-reported presence or history of the conditions listed in the appendices.
  7. Self-reported current use of medication known to interact with any of the medications listed in the appendices.
  8. Inability or unwillingness to be followed up for the trial period.

For M-M-R II

  • Pregnant women.
  • Individuals receiving high dose corticosteroids, other immuno-suppressive drugs, alkylating agents or anti-metabolites.
  • Individuals undergoing radiotherapy.
  • Any malignant disease either untreated or currently undergoing therapy.
  • History of administration of gammaglobulin or blood transfusions within the previous 3 months.
  • Participants with an allergy to the MR (MMR) vaccine or its components, including neomycin.
  • Idiopathic thrombocytopenic purpura (ITP)
  • Untreated tuberculosis
  • Prior receipt of any vaccines (licensed or investigational) ≤30 days before enrollment
  • Planned receipt of any vaccine other than the study intervention within 30 days before and after the study vaccination
  • 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).
  • Any confirmed or suspected immunosuppressive or immunodeficient state, including untreated HIV infection with a CD4T count <200 /mL
  • Asplenia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04333732


Contacts
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Contact: Linda Yun, BS, CCRP 314-273-2240 crowntrial@email.wustl.edu
Contact: Sherry McKinnon, MS, CCRP 314-286-1768 crowntrial@email.wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Linda Yun, BS, CCRP    314-273-2240    CrownTrial@email.wustl.edu   
Contact: Sherry McKinnon, MS, CCRP    314-286-1768    CrownTrial@email.wustl.edu   
Principal Investigator: Michael S. Avidan, MBBCh, FCASA         
Sub-Investigator: Mary Politi, PhD         
Principal Investigator: Eric Dubberke, MD, MSPH, FSHEA, FIDSA         
Sub-Investigator: Elvin Geng, MD, MPH         
Sub-Investigator: Graham Colditz, MD, DrPH         
Sub-Investigator: Eric Lenz, MD         
Sub-Investigator: Victor Davila-Roman, MD, FACC, FASE         
Sub-Investigator: William Powderly, MD         
Sub-Investigator: Shabaana A. Khader, PhD         
Canada, Ontario
Unity Health Toronto Not yet recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: David Mazer, MD    (416) 864-5825    David.Mazer@unityhealth.to   
Principal Investigator: David Mazer, MD         
Ghana
University of Ghana Medical Centre Not yet recruiting
Accra, Greater Accra Region, Ghana, 00233
Contact: George Kyei, MD, PhD    +233551989937    mailto:gkyei@noguchi.ug.edu.gh   
Contact: Nana Adwoa Dsane, MA    +233243376304      
Principal Investigator: Kwadwo Koram, MB ChB PhD         
Ireland
St James's Hospital Not yet recruiting
Dublin, Leinster, Ireland, Dublin 8
Contact: Ellen O'Sullivan, MD, FRCA,FCAI    353876993178    ellenosullivan2000@gmail.com   
Netherlands
Radboud University Medical Center Not yet recruiting
Nijmegen, Netherlands, 6525GA
Contact: Mihai G Netea, MD PhD    +31-24-3618819    Mihai.Netea@radboudumc.nl   
South Africa
Universitas Academic Hospital Not yet recruiting
Bloemfontein, Free State, South Africa, 9301
Contact: Edwin Turton, MBChB, Dip PEC, DA, MMed, FCA    +27 82 804 6839    turtonew@ufs.ac.za   
Principal Investigator: Edwin Turton, MBChB, Dip PEC, DA, MMed, FCA         
Wits RHI, University of the Witwatersrand Not yet recruiting
Johannesburg, Gauteng, South Africa, 2001
Contact: Sinead Delany-Moretlwe, MBChB, PhD, DTM&H    +27 82 377 6275    sdelany@wrhi.ac.za   
Contact: Michelle Moorhouse, MBChB         
Sub-Investigator: Gloria Maimela, MBBCh MBA         
Sub-Investigator: Saiqa Mullick, MBBCh PhD         
Sub-Investigator: Catherine Martin, MBBCh MSc         
Steve Biko Academic Hospital Not yet recruiting
Pretoria, Gauteng, South Africa, 0001
Contact: Sophie Mathijs, MBChB, MPharmMed    +27 836506425    sandra.spijkerman@up.ac.za   
Principal Investigator: Sophie Mathijs, MBChB, MPharmMed         
Tygerberg Hospital Not yet recruiting
Cape Town, Western Cape, South Africa, 7505
Contact: Coenraad Koegelenberg, MBChB, MMED, FCP, MRCP, PhD    +27 833201307    coeniefn@sun.ac.za   
Contact: Sean Chetty, MBChB, FCA, PhD         
Sub-Investigator: Coenraad Koegelenberg, MBChB, MMED, FCP, MRCP, PhD         
Sub-Investigator: Sean Chetty, MBChB, FCA, PhD         
Groote Schuur Hospital Not yet recruiting
Cape Town, Western Cape, South Africa, 7925
Contact: Bruce Biccard, MBChB,FCA,PhD    +27 21 4045015    bruce.biccard@uct.ac.za   
Contact: Leon du Toit, MBChB, FCA(SA)    +27 (84) 5757330    leon.alive@gmail.com   
Principal Investigator: Bruce Biccard, MBChB,FCA,PhD         
Sub-Investigator: Leon du Toit, MBChB, FCA(SA)         
Sub-Investigator: Willem Stassen, BTech, MPhil, PhD         
Sub-Investigator: Lee Alan Wallis, MBChB, FCS, PhD         
Sub-Investigator: Ivan Joubert, MBChB, FCA         
Sub-Investigator: Linda-Gail Bekker, MBChB, DTM         
Sub-Investigator: Catherine Orrell, MBChB MMed MSc, PhD         
Sub-Investigator: Lulu Nair, MBChB, DCH, DTM&H, MPH,         
Sub-Investigator: Katherine Gill, MBChB         
Sub-Investigator: Amy Ward, PhD         
Sub-Investigator: Graeme Meintjes, MBChB, FRCP, FCP         
Sub-Investigator: Mark Hatherill, MBChB, DCH, MRCP, FCPaed         
Sub-Investigator: Lorraine Swanepoel, B.Sc.Pharm, Hons. B.Pharm         
Uganda
Infectious Diseases Institute Kampala, Uganda Not yet recruiting
Kampala, Uganda
Contact: Barbara Castelnuovo, PhD    +256786623613    bcastelnuovo@idi.co.ug   
Contact: Stephen Okoboi, Master    +256704817590    sokoboi@idi.co.ug   
Principal Investigator: Barbara Castelnuovo, PhD         
Sub-Investigator: Stephen Okoboi, Master         
Sub-Investigator: Eva Laker, Master         
United Kingdom
University College London Not yet recruiting
London, United Kingdom
Contact: Laurence Lovat, MD, PhD    020 3447 7488    laurence.lovat@nhs.net   
Principal Investigator: Laurence Lovat, MD, PhD         
Sub-Investigator: Hakim-Moulay Dehbi, PhD         
Sub-Investigator: Nick Freemantle, PhD         
Sub-Investigator: Dermot McGuckin, MD         
Sub-Investigator: Gemma Jones, MsC         
Sub-Investigator: Ramani Moonesinghe, MD         
Sub-Investigator: Josheph Standing, MD         
Sub-Investigator: Andrew Hill, MD         
Zambia
Levy Mwanawasa University Teaching Hospital Not yet recruiting
Lusaka, Zambia, 10101
Contact: Laston Chikoya, BSc, MBChB, MMed, MD    +260977349415    chikoyal@yahoo.com   
Contact: Bright Nsokolo, BScHB, MB ChB, MMED    +260977884895    b_nsokolo@yahoo.com   
Principal Investigator: Izukanji Sikazwe, MBChB, MPH         
Sub-Investigator: Roma Chilengi, MBChB, MSc, ACCRP         
Sub-Investigator: Carolyn Bolton, MBBCh, MSc         
Sub-Investigator: Chikumbutso Chipeta, BScHB, MB ChB         
Sub-Investigator: Bright Nsokolo, BScHB, MB ChB, MMED         
Sub-Investigator: Lloyd Mulenga, BScHB, MBCHB, MScID, MMED         
Centre for Infectious Disease Research in Zambia [CIDRZ] Not yet recruiting
Lusaka, Zambia, H8R9+9V
Contact: Izukanji Sikazwe         
Principal Investigator: Izukanji Sikazwe         
Sub-Investigator: Roma Chilengi         
Sub-Investigator: Carolyn Bolton         
Sub-Investigator: Chikumbutso Chipeta         
Zimbabwe
University of Zimbabwe Clinical Trials Research Centre Not yet recruiting
Harare, Zimbabwe
Contact: Nyaradzo Mavis Mgodi, MBChB, MMed    +263 772 264 616    nmgodi@uzchs-ctrc.org   
Contact: Teaclar Gamuchirai Nematadzira, : MBChB, Msc       tnematadzira@uzchs-ctrc.org   
Principal Investigator: Nyaradzo Mavis Mgodi, MBChB, MMed         
Sub-Investigator: Teaclar Gamuchirai Nematadzira, MBChB, Msc         
Sub-Investigator: Gift Tafadzwa Chareka, Bachelor of Pharm, MscClin         
Sub-Investigator: Allen Taguma Matubu, Bachelor Lab Sciences         
Sponsors and Collaborators
Washington University School of Medicine
COVID -19 Therapeutics Accelerator
Investigators
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Principal Investigator: Michael S. Avidan, MBBCh Washington Univeristy School of Medicine
Principal Investigator: Ramani Moonesinghe, MD University College, London
Principal Investigator: Helen Rees, MD Wits University
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Responsible Party: Michael Avidan, Professor of Anesthesiology and Surgery, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04333732    
Other Study ID Numbers: 202004099
INV-017499 ( Other Grant/Funding Number: Bill and Melinda Gates Foundation )
First Posted: April 3, 2020    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in the main publication may be shared, after de-identification.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: From 3 months after the last patient last visit onward.
Access Criteria: Investigators whose proposed use of the data has been approved by a review committee identified for this purpose.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Avidan, Washington University School of Medicine:
COVID 19
Health care workers
M-M-R II ®