CROWN CORONATION: COVID-19 Research Outcomes Worldwide Network for CORONAvirus prevenTION (CROWN CORONA)
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|ClinicalTrials.gov Identifier: NCT04333732|
Recruitment Status : Active, not recruiting
First Posted : April 3, 2020
Last Update Posted : July 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|COVID 19||Drug: MR or M-M-R II ® vaccine Drug: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3545 participants|
|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.|
|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 Adults|
|Actual Study Start Date :||September 4, 2020|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||November 2021|
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
- 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.
- 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).
- 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
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
|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|