Trial Outcomes & Findings for CROWN CORONATION: COVID-19 Research Outcomes Worldwide Network for CORONAvirus prevenTION (NCT NCT04333732)

Last Updated: 2024-03-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

3411 participants

Primary outcome timeframe

60 days after receiving trial intervention

Results posted on

2024-03-26

Participant Flow

Participant milestones

Participant milestones
Measure	M-M-R II ® Education and surveillance plus M-M-R II ® MR or M-M-R II ® vaccine: Education and surveillance plus MR or M-M-R II ® vaccine	Placebo Education and surveillance plus placebo Placebo: Placebo injection
Overall Study STARTED	1722	1689
Overall Study COMPLETED	1607	1545
Overall Study NOT COMPLETED	115	144

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	M-M-R II ® n=1722 Participants Education and surveillance plus M-M-R II ® MR or M-M-R II ® vaccine: Education and surveillance plus MR or M-M-R II ® vaccine	Placebo n=1689 Participants Education and surveillance plus placebo Placebo: Placebo injection	Total n=3411 Participants Total of all reporting groups
Age, Customized <50 years	1566 Participants n=1722 Participants	1539 Participants n=1689 Participants	3105 Participants n=3411 Participants
Age, Customized >=50 years	156 Participants n=1722 Participants	150 Participants n=1689 Participants	306 Participants n=3411 Participants
Sex: Female, Male Female	1033 Participants n=1722 Participants	992 Participants n=1689 Participants	2025 Participants n=3411 Participants
Sex: Female, Male Male	689 Participants n=1722 Participants	697 Participants n=1689 Participants	1386 Participants n=3411 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	85 participants n=1722 Participants	68 participants n=1689 Participants	153 participants n=3411 Participants
Region of Enrollment South Africa	1252 participants n=1722 Participants	1240 participants n=1689 Participants	2492 participants n=3411 Participants
Region of Enrollment United Kingdom	26 participants n=1722 Participants	22 participants n=1689 Participants	48 participants n=3411 Participants
Region of Enrollment Ghana	76 participants n=1722 Participants	75 participants n=1689 Participants	151 participants n=3411 Participants
Region of Enrollment Zambia	283 participants n=1722 Participants	284 participants n=1689 Participants	567 participants n=3411 Participants

PRIMARY outcome

Timeframe: 60 days after receiving trial intervention

Outcome measures

Outcome measures
Measure	M-M-R II ® n=1607 Participants Education and surveillance plus M-M-R II ® MR or M-M-R II ® vaccine: Education and surveillance plus MR or M-M-R II ® vaccine	Placebo n=1545 Participants Education and surveillance plus placebo Placebo: Placebo injection
Number of Participants With Symptomatic COVID-19 at 60 Days	24 Participants	19 Participants

SECONDARY outcome

Timeframe: 150 days after receiving trial intervention

Outcome measures

Outcome measures
Measure	M-M-R II ® n=1585 Participants Education and surveillance plus M-M-R II ® MR or M-M-R II ® vaccine: Education and surveillance plus MR or M-M-R II ® vaccine	Placebo n=1544 Participants Education and surveillance plus placebo Placebo: Placebo injection
Number of Participants With Symptomatic COVID-19 at 150 Days	65 Participants	64 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	M-M-R II ® n=1607 Participants Education and surveillance plus M-M-R II ® MR or M-M-R II ® vaccine: Education and surveillance plus MR or M-M-R II ® vaccine	Placebo n=1544 Participants Education and surveillance plus placebo Placebo: Placebo injection
Severity of COVID-19 Measured at 60 Days After Intervention	3 Participants	1 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	M-M-R II ® n=1585 Participants Education and surveillance plus M-M-R II ® MR or M-M-R II ® vaccine: Education and surveillance plus MR or M-M-R II ® vaccine	Placebo n=1544 Participants Education and surveillance plus placebo Placebo: Placebo injection
Severity of COVID-19 at 150 Days After Intervention	3 Participants	1 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	M-M-R II ® n=945 Participants Education and surveillance plus M-M-R II ® MR or M-M-R II ® vaccine: Education and surveillance plus MR or M-M-R II ® vaccine	Placebo n=951 Participants Education and surveillance plus placebo Placebo: Placebo injection
Risk of SARS-CoV-2 Infection up to 150 Days After Trial Intervention	100 Participants	98 Participants

Adverse Events

M-M-R II ®

Serious events: 11 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	M-M-R II ® n=1722 participants at risk Education and surveillance plus M-M-R II ® MR or M-M-R II ® vaccine: Education and surveillance plus MR or M-M-R II ® vaccine	Placebo n=1689 participants at risk Education and surveillance plus placebo Placebo: Placebo injection
Infections and infestations COVID-19	0.23% 4/1722 • Number of events 4 • 150 days from the date of administration of the investigational medicinal product Common Terminology Criteria for Adverse Events (CTACAE; v5.0 27-Nov-2017)	0.06% 1/1689 • Number of events 1 • 150 days from the date of administration of the investigational medicinal product Common Terminology Criteria for Adverse Events (CTACAE; v5.0 27-Nov-2017)
Reproductive system and breast disorders Ovarian infection	0.06% 1/1722 • Number of events 2 • 150 days from the date of administration of the investigational medicinal product Common Terminology Criteria for Adverse Events (CTACAE; v5.0 27-Nov-2017)	0.00% 0/1689 • 150 days from the date of administration of the investigational medicinal product Common Terminology Criteria for Adverse Events (CTACAE; v5.0 27-Nov-2017)
Cardiac disorders Thromboembolic event	0.06% 1/1722 • Number of events 1 • 150 days from the date of administration of the investigational medicinal product Common Terminology Criteria for Adverse Events (CTACAE; v5.0 27-Nov-2017)	0.00% 0/1689 • 150 days from the date of administration of the investigational medicinal product Common Terminology Criteria for Adverse Events (CTACAE; v5.0 27-Nov-2017)
Psychiatric disorders Suicide attempt	0.06% 1/1722 • Number of events 1 • 150 days from the date of administration of the investigational medicinal product Common Terminology Criteria for Adverse Events (CTACAE; v5.0 27-Nov-2017)	0.00% 0/1689 • 150 days from the date of administration of the investigational medicinal product Common Terminology Criteria for Adverse Events (CTACAE; v5.0 27-Nov-2017)
Pregnancy, puerperium and perinatal conditions Pre-eclampsia	0.00% 0/1722 • 150 days from the date of administration of the investigational medicinal product Common Terminology Criteria for Adverse Events (CTACAE; v5.0 27-Nov-2017)	0.06% 1/1689 • Number of events 1 • 150 days from the date of administration of the investigational medicinal product Common Terminology Criteria for Adverse Events (CTACAE; v5.0 27-Nov-2017)
Injury, poisoning and procedural complications Right sided calcaneal fracture	0.06% 1/1722 • Number of events 1 • 150 days from the date of administration of the investigational medicinal product Common Terminology Criteria for Adverse Events (CTACAE; v5.0 27-Nov-2017)	0.00% 0/1689 • 150 days from the date of administration of the investigational medicinal product Common Terminology Criteria for Adverse Events (CTACAE; v5.0 27-Nov-2017)
Nervous system disorders Headache	0.06% 1/1722 • Number of events 1 • 150 days from the date of administration of the investigational medicinal product Common Terminology Criteria for Adverse Events (CTACAE; v5.0 27-Nov-2017)	0.06% 1/1689 • Number of events 1 • 150 days from the date of administration of the investigational medicinal product Common Terminology Criteria for Adverse Events (CTACAE; v5.0 27-Nov-2017)
Nervous system disorders seizure	0.00% 0/1722 • 150 days from the date of administration of the investigational medicinal product Common Terminology Criteria for Adverse Events (CTACAE; v5.0 27-Nov-2017)	0.06% 1/1689 • Number of events 1 • 150 days from the date of administration of the investigational medicinal product Common Terminology Criteria for Adverse Events (CTACAE; v5.0 27-Nov-2017)
Infections and infestations Pyrexia	0.06% 1/1722 • Number of events 1 • 150 days from the date of administration of the investigational medicinal product Common Terminology Criteria for Adverse Events (CTACAE; v5.0 27-Nov-2017)	0.00% 0/1689 • 150 days from the date of administration of the investigational medicinal product Common Terminology Criteria for Adverse Events (CTACAE; v5.0 27-Nov-2017)
Gastrointestinal disorders Gastroenteritis	0.06% 1/1722 • Number of events 1 • 150 days from the date of administration of the investigational medicinal product Common Terminology Criteria for Adverse Events (CTACAE; v5.0 27-Nov-2017)	0.00% 0/1689 • 150 days from the date of administration of the investigational medicinal product Common Terminology Criteria for Adverse Events (CTACAE; v5.0 27-Nov-2017)
Infections and infestations Tuberculous meningitis	0.00% 0/1722 • 150 days from the date of administration of the investigational medicinal product Common Terminology Criteria for Adverse Events (CTACAE; v5.0 27-Nov-2017)	0.06% 1/1689 • Number of events 1 • 150 days from the date of administration of the investigational medicinal product Common Terminology Criteria for Adverse Events (CTACAE; v5.0 27-Nov-2017)

Other adverse events

Adverse event data not reported

Additional Information

Professor Michael S. Avidan

Washington University School of Medicine in Saint Louis

Phone: +1-(314)-273-2456

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER