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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04333732




Registration number
NCT04333732
Ethics application status
Date submitted
31/03/2020
Date registered
3/04/2020

Titles & IDs
Public title
CROWN CORONATION: COVID-19 Research Outcomes Worldwide Network for CORONAvirus prevenTION
Scientific 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
Secondary ID [1] 0 0
INV-017499
Secondary ID [2] 0 0
202004099
Universal Trial Number (UTN)
Trial acronym
CROWN CORONA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID 19 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MR or M-M-R II ® vaccine
Treatment: Drugs - Placebo

Experimental: M-M-R II ® - Education and surveillance plus M-M-R II ® Single dose, 0.5 mL subcutaneous injection of M-M-R II ®

Placebo comparator: Placebo - Education and surveillance plus placebo Single dose, 0.5 mL subcutaneous injection of 0.9% saline


Treatment: Drugs: MR or M-M-R II ® vaccine
Education and surveillance plus MR or M-M-R II ® vaccine

Treatment: Drugs: Placebo
Placebo injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Symptomatic COVID-19 at 60 Days
Timepoint [1] 0 0
60 days after receiving trial intervention
Secondary outcome [1] 0 0
Number of Participants With Symptomatic COVID-19 at 150 Days
Timepoint [1] 0 0
150 days after receiving trial intervention
Secondary outcome [2] 0 0
Severity of COVID-19 Measured at 60 Days After Intervention
Timepoint [2] 0 0
60 days after receiving trial intervention
Secondary outcome [3] 0 0
Severity of COVID-19 at 150 Days After Intervention
Timepoint [3] 0 0
150 days
Secondary outcome [4] 0 0
Risk of SARS-CoV-2 Infection up to 150 Days After Trial Intervention
Timepoint [4] 0 0
150 days

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 (not including the flu vaccination via injection)
* 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/12/2021
Sample size
Target
Accrual to date
Final
3411
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Missouri
Country [2] 0 0
Ghana
State/province [2] 0 0
Greater Accra Region
Country [3] 0 0
South Africa
State/province [3] 0 0
Cape Town
Country [4] 0 0
South Africa
State/province [4] 0 0
Free State
Country [5] 0 0
South Africa
State/province [5] 0 0
Johannesburg,Gauteng
Country [6] 0 0
South Africa
State/province [6] 0 0
Johannesburg
Country [7] 0 0
South Africa
State/province [7] 0 0
Tshwane
Country [8] 0 0
South Africa
State/province [8] 0 0
Western Cape
Country [9] 0 0
South Africa
State/province [9] 0 0
Chatsworth
Country [10] 0 0
South Africa
State/province [10] 0 0
Durban
Country [11] 0 0
South Africa
State/province [11] 0 0
Tembisa
Country [12] 0 0
United Kingdom
State/province [12] 0 0
London
Country [13] 0 0
Zambia
State/province [13] 0 0
Lusaka

Funding & Sponsors
Primary sponsor type
Other
Name
Washington University School of Medicine
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
COVID -19 Therapeutics Accelerator
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael S. Avidan, MBBCh
Address 0 0
Washington Univeristy School of Medicine
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04333732