CROWN CORONATION: COVID-19 Research Outcomes Worldwide Network for CORONAvirus prevenTION
- Conditions
- COVID 19
- Interventions
- Drug: MR or M-M-R II ® vaccineDrug: Placebo
- Registration Number
- NCT04333732
- Lead Sponsor
- 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.
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3411
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description M-M-R II ® MR or M-M-R II ® vaccine Education and surveillance plus M-M-R II ® Single dose, 0.5 mL subcutaneous injection of M-M-R II ® Placebo Placebo Education and surveillance plus placebo Single dose, 0.5 mL subcutaneous injection of 0.9% saline
- Primary Outcome Measures
Name Time Method Number of Participants With Symptomatic COVID-19 at 60 Days 60 days after receiving trial intervention Incidence of 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 the intervention and control groups in adults with repeated exposures to SARS-CoV-2 by day 60 after receiving trial intervention.
- Secondary Outcome Measures
Name Time Method Number of Participants With Symptomatic COVID-19 at 150 Days 150 days after receiving trial intervention Incidence of 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 the intervention and control groups in adults with repeated exposures to SARS-CoV-2 by day 150 after receiving trial intervention.
Risk of SARS-CoV-2 Infection up to 150 Days After Trial Intervention 150 days Risk of SARS-CoV-2 infection by serology (anti-nucleocapsid antibody) in the intervention and control groups in adults with repeated exposures to SARS-CoV-2 by day 150 after receiving trial intervention. Infection with SARS CoV-2 during the course of the trial was diagnosed when IgG antibodies to the viral nucleocapsid protein were present from the 150 day specimen, but not the baseline specimen.
Severity of COVID-19 Measured at 60 Days After Intervention 60 days after receiving trial intervention Severity of COVID-19 in adults who become infected with SARS-CoV-2 by day 60 after receiving trial intervention. Severity will be graded on a simplified version of the ordinal WHO COVID-19 severity scale ((i) uninfected, (ii) infected but ambulatory \[mild disease\], (iii) infected and hospitalized \[moderate or severe disease\] or dead). Practically, this outcome measure was treated as a binary outcome - participants were classified and counted as having severe COVID-19 if they met the definition for the primary outcome of symptomatic COVID-19 AND were hospitalized during the course of their COVID-19 illness.
Severity of COVID-19 at 150 Days After Intervention 150 days Severity of COVID-19 in adults who become infected with SARS-CoV-2 by day 150 after receiving trial intervention. Severity will be graded on a simplified version of the ordinal WHO COVID-19 severity scale ((i) uninfected, (ii) infected but ambulatory \[mild disease\], (iii) infected and hospitalized \[moderate or severe disease\] or dead). Practically, this outcome measure was treated as a binary outcome - participants were classified and counted as having severe COVID-19 if they met the definition for the primary outcome of symptomatic COVID-19 AND were hospitalized during the course of their COVID-19 illness.
Trial Locations
- Locations (17)
JOSHA Research
🇿🇦Bloemfontein, Free State, South Africa
University of Ghana Medical Centre
🇬🇭Accra, Greater Accra Region, Ghana
Groote Schuur Hospital
🇿🇦Cape Town, Western Cape, South Africa
University College London
🇬🇧London, United Kingdom
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Perinatal HIV Research Unit (PHRU)
🇿🇦Diepkloof, Johannesburg, South Africa
Groote Schuur/J52, Desmond Tutu Health Foundation
🇿🇦Mowbray, Cape Town, South Africa
Masiphumelele, Desmond Tutu Health Foundation
🇿🇦Sunnydale, Cape Town, South Africa
Wits RHI, University of the Witwatersrand
🇿🇦Hillbrow, Johannesburg,Gauteng, South Africa
Aurum Institute Tembisa
🇿🇦Tembisa, South Africa
Chatsworth, HIV Prevention Research Unit, South African Medical Research Council
🇿🇦Chatsworth, South Africa
Setshaba Research Centre
🇿🇦Soshanguve, Tshwane, South Africa
Clinical HIV Research Unit (CHRU)
🇿🇦Auckland Park, Johannesburg, South Africa
FAMCRU (Family Clinical Research with Ubuntu)
🇿🇦Cape Town, South Africa
Centre for Infectious Disease Research in Zambia [CIDRZ]
🇿🇲Lusaka, Zambia
Levy Mwanawasa University Teaching Hospital
🇿🇲Lusaka, Zambia
Isipingo, HIV Prevention Research Unit, South African Medical Research Council
🇿🇦Durban, South Africa