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An International, Multi-site, Bayesian Platform Adaptive, Randomized, Placebo-controlled Trial Assessing the Effectiveness of Candidate Agents in Mitigating COVID-19 Disease in Adults
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.
CROWN CORONATION is an international, Bayesian platform adaptive, randomized, placebo-controlled trial assessing the effectiveness of candidate interventions in preventing COVID-19 disease in adults. 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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Washington University School of Medicine
St Louis, Missouri, United States
University of Ghana Medical Centre
Accra, Greater Accra Region, Ghana
Groote Schuur/J52, Desmond Tutu Health Foundation
Mowbray, Cape Town, South Africa
Masiphumelele, Desmond Tutu Health Foundation
Sunnydale, Cape Town, South Africa
JOSHA Research
Bloemfontein, Free State, South Africa
Wits RHI, University of the Witwatersrand
Hillbrow, Johannesburg,Gauteng, South Africa
Clinical HIV Research Unit (CHRU)
Auckland Park, Johannesburg, South Africa
Perinatal HIV Research Unit (PHRU)
Diepkloof, Johannesburg, South Africa
Setshaba Research Centre
Soshanguve, Tshwane, South Africa
Groote Schuur Hospital
Cape Town, Western Cape, South Africa
Start Date
September 4, 2020
Primary Completion Date
August 10, 2021
Completion Date
December 3, 2021
Last Updated
March 26, 2024
3,411
ACTUAL participants
MR or M-M-R II ® vaccine
DRUG
Placebo
DRUG
Lead Sponsor
Washington University School of Medicine
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07013903