Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-30 @ 6:42 PM
Study NCT ID:
NCT04333732
Status:
COMPLETED
Last Update Posted:
2024-03-26
First Post:
2020-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CROWN CORONATION: COVID-19 Research Outcomes Worldwide Network for CORONAvirus prevenTION
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Canada', 'Ireland', 'Netherlands', 'Uganda', 'Zimbabwe'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'avidanm@wustl.edu', 'phone': '+1-(314)-273-2456', 'title': 'Professor Michael S. Avidan', 'organization': 'Washington University School of Medicine in Saint Louis'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '150 days from the date of administration of the investigational medicinal product', 'description': 'Common Terminology Criteria for Adverse Events (CTACAE; v5.0 27-Nov-2017)', 'eventGroups': [{'id': 'EG000', 'title': 'M-M-R II ®', 'description': 'Education and surveillance plus M-M-R II ®\n\nMR or M-M-R II ® vaccine: Education and surveillance plus MR or M-M-R II ® vaccine', 'otherNumAtRisk': 1722, 'deathsNumAtRisk': 1722, 'otherNumAffected': 0, 'seriousNumAtRisk': 1722, 'deathsNumAffected': 0, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Education and surveillance plus placebo\n\nPlacebo: Placebo injection', 'otherNumAtRisk': 1689, 'deathsNumAtRisk': 1689, 'otherNumAffected': 0, 'seriousNumAtRisk': 1689, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'seriousEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1722, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1689, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ovarian infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1722, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1689, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1722, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1689, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1722, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1689, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pre-eclampsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1722, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1689, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Right sided calcaneal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1722, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1689, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1722, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1689, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1722, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1689, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1722, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1689, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1722, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1689, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tuberculous meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1722, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1689, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Symptomatic COVID-19 at 60 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1607', 'groupId': 'OG000'}, {'value': '1545', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'M-M-R II ®', 'description': 'Education and surveillance plus M-M-R II ®\n\nMR or M-M-R II ® vaccine: Education and surveillance plus MR or M-M-R II ® vaccine'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Education and surveillance plus placebo\n\nPlacebo: Placebo injection'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.52', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '1.1', 'groupDescription': 'The primary endpoint was analysed using a Bayesian logistic regression, including as covariates the treatment arm, age (\\<50 vs. ≥50), and a random effect for site', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '60 days after receiving trial intervention', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Symptomatic COVID-19 at 150 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1585', 'groupId': 'OG000'}, {'value': '1544', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'M-M-R II ®', 'description': 'Education and surveillance plus M-M-R II ®\n\nMR or M-M-R II ® vaccine: Education and surveillance plus MR or M-M-R II ® vaccine'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Education and surveillance plus placebo\n\nPlacebo: Placebo injection'}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.95', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '1.3', 'groupDescription': 'The endpoint was analysed using a Bayesian logistic regression, including as covariates the treatment arm, age (\\<50 vs. ≥50), and a random effect for site', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'difference, 0·04%, 95% CI, -1·4% to 1·3%, p=0·95).'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '150 days after receiving trial intervention', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Severity of COVID-19 Measured at 60 Days After Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1607', 'groupId': 'OG000'}, {'value': '1544', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'M-M-R II ®', 'description': 'Education and surveillance plus M-M-R II ® Single dose, 0.5 mL subcutaneous injection of M-M-R II ®\n\nMR or M-M-R II ® vaccine: Education and surveillance plus MR or M-M-R II ® vaccine'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Education and surveillance plus placebo Single dose, 0.5 mL subcutaneous injection of 0.9% saline\n\nPlacebo: Placebo injection'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '60 days after receiving trial intervention', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Severity of COVID-19 at 150 Days After Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1585', 'groupId': 'OG000'}, {'value': '1544', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'M-M-R II ®', 'description': 'Education and surveillance plus M-M-R II ® Single dose, 0.5 mL subcutaneous injection of M-M-R II ®\n\nMR or M-M-R II ® vaccine: Education and surveillance plus MR or M-M-R II ® vaccine'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Education and surveillance plus placebo Single dose, 0.5 mL subcutaneous injection of 0.9% saline\n\nPlacebo: Placebo injection'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '150 days', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Risk of SARS-CoV-2 Infection up to 150 Days After Trial Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '945', 'groupId': 'OG000'}, {'value': '951', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'M-M-R II ®', 'description': 'Education and surveillance plus M-M-R II ® Single dose, 0.5 mL subcutaneous injection of M-M-R II ®\n\nMR or M-M-R II ® vaccine: Education and surveillance plus MR or M-M-R II ® vaccine'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Education and surveillance plus placebo Single dose, 0.5 mL subcutaneous injection of 0.9% saline\n\nPlacebo: Placebo injection'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '150 days', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'M-M-R II ®', 'description': 'Education and surveillance plus M-M-R II ®\n\nMR or M-M-R II ® vaccine: Education and surveillance plus MR or M-M-R II ® vaccine'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Education and surveillance plus placebo\n\nPlacebo: Placebo injection'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Number randomised', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1722'}, {'groupId': 'FG001', 'numSubjects': '1689'}]}, {'type': 'COMPLETED', 'comment': '60 day follow-up for primary outcome', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1607'}, {'groupId': 'FG001', 'numSubjects': '1545'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '115'}, {'groupId': 'FG001', 'numSubjects': '144'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1722', 'groupId': 'BG000'}, {'value': '1689', 'groupId': 'BG001'}, {'value': '3411', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'M-M-R II ®', 'description': 'Education and surveillance plus M-M-R II ®\n\nMR or M-M-R II ® vaccine: Education and surveillance plus MR or M-M-R II ® vaccine'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Education and surveillance plus placebo\n\nPlacebo: Placebo injection'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1722', 'groupId': 'BG000'}, {'value': '1689', 'groupId': 'BG001'}, {'value': '3411', 'groupId': 'BG002'}]}], 'categories': [{'title': '<50 years', 'measurements': [{'value': '1566', 'groupId': 'BG000'}, {'value': '1539', 'groupId': 'BG001'}, {'value': '3105', 'groupId': 'BG002'}]}, {'title': '>=50 years', 'measurements': [{'value': '156', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '306', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1722', 'groupId': 'BG000'}, {'value': '1689', 'groupId': 'BG001'}, {'value': '3411', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1033', 'groupId': 'BG000'}, {'value': '992', 'groupId': 'BG001'}, {'value': '2025', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '689', 'groupId': 'BG000'}, {'value': '697', 'groupId': 'BG001'}, {'value': '1386', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1722', 'groupId': 'BG000'}, {'value': '1689', 'groupId': 'BG001'}, {'value': '3411', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}]}, {'title': 'South Africa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1722', 'groupId': 'BG000'}, {'value': '1689', 'groupId': 'BG001'}, {'value': '3411', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1252', 'groupId': 'BG000'}, {'value': '1240', 'groupId': 'BG001'}, {'value': '2492', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1722', 'groupId': 'BG000'}, {'value': '1689', 'groupId': 'BG001'}, {'value': '3411', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}, {'title': 'Ghana', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1722', 'groupId': 'BG000'}, {'value': '1689', 'groupId': 'BG001'}, {'value': '3411', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}]}, {'title': 'Zambia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1722', 'groupId': 'BG000'}, {'value': '1689', 'groupId': 'BG001'}, {'value': '3411', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '283', 'groupId': 'BG000'}, {'value': '284', 'groupId': 'BG001'}, {'value': '567', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-12', 'size': 1683084, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-09-21T08:55', 'hasProtocol': True}, {'date': '2021-01-05', 'size': 283699, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-09-21T08:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3411}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2021-12-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-27', 'studyFirstSubmitDate': '2020-03-31', 'resultsFirstSubmitDate': '2022-09-22', 'studyFirstSubmitQcDate': '2020-04-02', 'lastUpdatePostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-27', 'studyFirstPostDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Symptomatic COVID-19 at 60 Days', 'timeFrame': '60 days after receiving trial intervention', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Symptomatic COVID-19 at 150 Days', 'timeFrame': '150 days after receiving trial intervention', 'description': '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.'}, {'measure': 'Severity of COVID-19 Measured at 60 Days After Intervention', 'timeFrame': '60 days after receiving trial intervention', 'description': '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.'}, {'measure': 'Severity of COVID-19 at 150 Days After Intervention', 'timeFrame': '150 days', 'description': '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.'}, {'measure': 'Risk of SARS-CoV-2 Infection up to 150 Days After Trial Intervention', 'timeFrame': '150 days', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID 19', 'Health care workers', 'M-M-R II ®'], 'conditions': ['COVID 19']}, 'referencesModule': {'references': [{'pmid': '41035643', 'type': 'DERIVED', 'citation': 'Delany-Moretlwe S, Dehbi HM, Sikazwe I, Kyei G, Koram K, Dubberke E, Mwelase N, Hague D, Bekker LG, Yun L, Nel A, du Toit L, Biccard B, Gill K, Chipeta C, Mngadi KT, Lebina L, Dassaye R, Asari V, Fry SH, Turton E, Ahmed K, Kusi K, Adu-Amankwah S, Chilengi R, Chilekwa JC, Lovat L, McGuckin D, Caverly E, Politi M, Swan B, DeSchryver A, McKinnon S, Gupta A, Jones G, Freemantle N, Khader S, Rees H, Netea MG, Moonesinghe SR, Avidan MS. No evidence of MMR induced trained immunity to prevent SARS COV2: results from a multi-centre RCT. Front Immunol. 2025 Sep 16;16:1588190. doi: 10.3389/fimmu.2025.1588190. eCollection 2025.'}, {'pmid': '37153751', 'type': 'DERIVED', 'citation': 'Noverr MC, Yano J, Hagensee ME, Lin HY, Meyaski MC, Meyaski E, Cameron J, Shellito J, Trauth A, Fidel PL Jr. Effect of MMR Vaccination to Mitigate Severe Sequelae Associated With COVID-19: Challenges and Lessons Learned. Med Res Arch. 2023 Feb;11(2):3598. doi: 10.18103/mra.v11i2.3598.'}, {'pmid': '35713300', 'type': 'DERIVED', 'citation': 'Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.'}, {'pmid': '34473343', 'type': 'DERIVED', 'citation': 'Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nRandomization 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:\n\n* Education and surveillance plus MR or MMR vaccine\n* Education and surveillance plus Placebo\n\nWhile 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.\n\nAll 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n1. Volunteers without clinical evidence of COVID-19 infection aged 18 years and older.\n2. 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.\n3. Must have a mobile phone and access to the Internet for data collection purposes.\n4. Participants who are willing and able to provide informed consent via an electronic consent process.\n\nExclusion criteria\n\n1. Prior enrollment into other COVID-19 interventional prevention or treatment trials (observational trials not excluded).\n2. Self-reported or diagnosed current infection with SARS-CoV-2 or previous COVID-19 diagnosis.\n3. Self-reported current acute respiratory infection.\n4. 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.\n5. Self-reported known allergies to any of the IMPs and excipients of the IMPs and placebo.\n6. Self-reported presence or history of the conditions listed in the appendices.\n7. Self-reported current use of medication known to interact with any of the medications listed in the appendices.\n8. Inability or unwillingness to be followed up for the trial period.\n\nFor M-M-R II\n\n* Pregnant women.\n* Individuals receiving high dose corticosteroids, other immuno-suppressive drugs, alkylating agents or anti-metabolites.\n* Individuals undergoing radiotherapy.\n* Any malignant disease either untreated or currently undergoing therapy.\n* History of administration of gammaglobulin or blood transfusions within the previous 3 months.\n* Participants with an allergy to the MR (MMR) vaccine or its components, including neomycin.\n* Idiopathic thrombocytopenic purpura (ITP)\n* Untreated tuberculosis\n* Prior receipt of any vaccines (licensed or investigational) ≤30 days before enrollment\n* 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)\n* 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).\n* Any confirmed or suspected immunosuppressive or immunodeficient state, including untreated HIV infection with a CD4T count \\<200 /mL\n* Asplenia'}, 'identificationModule': {'nctId': 'NCT04333732', 'acronym': 'CROWN CORONA', 'briefTitle': 'CROWN CORONATION: COVID-19 Research Outcomes Worldwide Network for CORONAvirus prevenTION', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'An International, Multi-site, Bayesian Platform Adaptive, Randomized, Placebo-controlled Trial Assessing the Effectiveness of Candidate Agents in Mitigating COVID-19 Disease in Adults', 'orgStudyIdInfo': {'id': '202004099'}, 'secondaryIdInfos': [{'id': 'INV-017499', 'type': 'OTHER_GRANT', 'domain': 'Bill and Melinda Gates Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'M-M-R II ®', 'description': 'Education and surveillance plus M-M-R II ® Single dose, 0.5 mL subcutaneous injection of M-M-R II ®', 'interventionNames': ['Drug: MR or M-M-R II ® vaccine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Education and surveillance plus placebo Single dose, 0.5 mL subcutaneous injection of 0.9% saline', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'MR or M-M-R II ® vaccine', 'type': 'DRUG', 'otherNames': ['Merck'], 'description': 'Education and surveillance plus MR or M-M-R II ® vaccine', 'armGroupLabels': ['M-M-R II ®']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo injection', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '00233', 'city': 'Accra', 'state': 'Greater Accra Region', 'country': 'Ghana', 'facility': 'University of Ghana Medical Centre', 'geoPoint': {'lat': 5.55602, 'lon': -0.1969}}, {'zip': '7925', 'city': 'Mowbray', 'state': 'Cape Town', 'country': 'South Africa', 'facility': 'Groote Schuur/J52, Desmond Tutu Health Foundation', 'geoPoint': {'lat': -33.94802, 'lon': 18.47333}}, {'zip': '7975', 'city': 'Sunnydale', 'state': 'Cape Town', 'country': 'South Africa', 'facility': 'Masiphumelele, Desmond Tutu Health Foundation', 'geoPoint': {'lat': -30.4068, 'lon': 26.66686}}, {'zip': '9301', 'city': 'Bloemfontein', 'state': 'Free State', 'country': 'South Africa', 'facility': 'JOSHA Research', 'geoPoint': {'lat': -29.12107, 'lon': 26.214}}, {'zip': '2001', 'city': 'Hillbrow', 'state': 'Johannesburg,Gauteng', 'country': 'South Africa', 'facility': 'Wits RHI, University of the Witwatersrand', 'geoPoint': {'lat': -26.18995, 'lon': 28.04895}}, {'zip': '2092', 'city': 'Auckland Park', 'state': 'Johannesburg', 'country': 'South Africa', 'facility': 'Clinical HIV Research Unit (CHRU)', 'geoPoint': {'lat': -26.18135, 'lon': 28.00385}}, {'zip': '1864', 'city': 'Diepkloof', 'state': 'Johannesburg', 'country': 'South Africa', 'facility': 'Perinatal HIV Research Unit (PHRU)', 'geoPoint': {'lat': -26.24358, 'lon': 27.9505}}, {'zip': '0152', 'city': 'Soshanguve', 'state': 'Tshwane', 'country': 'South Africa', 'facility': 'Setshaba Research Centre', 'geoPoint': {'lat': -25.47288, 'lon': 28.09919}}, {'zip': '7925', 'city': 'Cape Town', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Groote Schuur Hospital', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '7505', 'city': 'Cape Town', 'country': 'South Africa', 'facility': 'FAMCRU (Family Clinical Research with Ubuntu)', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '4030', 'city': 'Chatsworth', 'country': 'South Africa', 'facility': 'Chatsworth, HIV Prevention Research Unit, South African Medical Research Council', 'geoPoint': {'lat': -33.54778, 'lon': 18.58201}}, {'zip': '4133', 'city': 'Durban', 'country': 'South Africa', 'facility': 'Isipingo, HIV Prevention Research Unit, South African Medical Research Council', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'zip': '1632', 'city': 'Tembisa', 'country': 'South Africa', 'facility': 'Aurum Institute Tembisa', 'geoPoint': {'lat': -26.00979, 'lon': 28.22762}}, {'zip': 'W1W 7TY', 'city': 'London', 'country': 'United Kingdom', 'facility': 'University College London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': '10101', 'city': 'Lusaka', 'country': 'Zambia', 'facility': 'Levy Mwanawasa University Teaching Hospital', 'geoPoint': {'lat': -15.40669, 'lon': 28.28713}}, {'zip': 'H8R9+9V', 'city': 'Lusaka', 'country': 'Zambia', 'facility': 'Centre for Infectious Disease Research in Zambia [CIDRZ]', 'geoPoint': {'lat': -15.40669, 'lon': 28.28713}}], 'overallOfficials': [{'name': 'Michael S. Avidan, MBBCh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington Univeristy School of Medicine'}, {'name': 'Ramani Moonesinghe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University College, London'}, {'name': 'Helen Rees, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wits University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'From 3 months after the last patient last visit onward.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in the main publication may be shared, after de-identification.', 'accessCriteria': 'Investigators whose proposed use of the data has been approved by a review committee identified for this purpose.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'COVID -19 Therapeutics Accelerator', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesiology and Surgery', 'investigatorFullName': 'Michael Avidan', 'investigatorAffiliation': 'Washington University School of Medicine'}}}}