Trial · NCT04333732
CROWN CORONATION: COVID-19 Research Outcomes Worldwide Network for CORONAvirus prevenTION
NCT04333732, Phase 3, Completed, Washington University School of Medicine; results first posted 2024-03-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. CROWN CORONATION: COVID-19 Research Outcomes Worldwide Network for CORONAvirus prevenTION. Trials, record NCT04333732. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04333732
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CROWN CORONATION: COVID-19 Research Outcomes Worldwide Network for CORONAvirus prevenTION
- NCT number
- NCT04333732
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,411 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- COVID 19
- Interventions
- MR or M-M-R II ® vaccine, Placebo
- First posted
- 2020-04-03
- Last updated
- 2024-03-26
- Results first posted
- 2024-03-26
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Symptomatic COVID-19 at 60 Days | 60 days after receiving trial intervention | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Symptomatic COVID-19 at 150 Days | 150 days after receiving trial intervention | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Severity of COVID-19 Measured at 60 Days After Intervention | 60 days after receiving trial intervention | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Severity of COVID-19 at 150 Days After Intervention | 150 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Risk of SARS-CoV-2 Infection up to 150 Days After Trial Intervention | 150 days | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Symptomatic COVID-19 at 60 Days | M-M-R II ® | 24 | Participants | ||
| Number of Participants With Symptomatic COVID-19 at 60 Days | Placebo | 19 | Participants | ||
| Number of Participants With Symptomatic COVID-19 at 150 Days | M-M-R II ® | 65 | Participants | ||
| Number of Participants With Symptomatic COVID-19 at 150 Days | Placebo | 64 | Participants | ||
| Severity of COVID-19 Measured at 60 Days After Intervention | M-M-R II ® | 3 | Participants | ||
| Severity of COVID-19 Measured at 60 Days After Intervention | Placebo | 1 | Participants | ||
| Severity of COVID-19 at 150 Days After Intervention | M-M-R II ® | 3 | Participants | ||
| Severity of COVID-19 at 150 Days After Intervention | Placebo | 1 | Participants | ||
| Risk of SARS-CoV-2 Infection up to 150 Days After Trial Intervention | M-M-R II ® | 100 | Participants | ||
| Risk of SARS-CoV-2 Infection up to 150 Days After Trial Intervention | Placebo | 98 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | M-M-R II ® | 1,722 | |
| Overall Study | STARTED | Placebo | 1,689 | |
| Overall Study | COMPLETED | M-M-R II ® | 1,607 | |
| Overall Study | COMPLETED | Placebo | 1,545 | |
| Overall Study | NOT COMPLETED | M-M-R II ® | 115 | |
| Overall Study | NOT COMPLETED | Placebo | 144 |
Source ClinicalTrials.gov
Adverse events22
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | COVID-19 | Infections and infestations | M-M-R II ® | 4 | 1,722 | 4 |
| serious | COVID-19 | Infections and infestations | Placebo | 1 | 1,689 | 1 |
| serious | Ovarian infection | Reproductive system and breast disorders | M-M-R II ® | 1 | 1,722 | 2 |
| serious | Ovarian infection | Reproductive system and breast disorders | Placebo | 0 | 1,689 | 0 |
| serious | Thromboembolic event | Cardiac disorders | M-M-R II ® | 1 | 1,722 | 1 |
| serious | Thromboembolic event | Cardiac disorders | Placebo | 0 | 1,689 | 0 |
| serious | Suicide attempt | Psychiatric disorders | M-M-R II ® | 1 | 1,722 | 1 |
| serious | Suicide attempt | Psychiatric disorders | Placebo | 0 | 1,689 | 0 |
| serious | Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | M-M-R II ® | 0 | 1,722 | 0 |
| serious | Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | Placebo | 1 | 1,689 | 1 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | M-M-R II ® | 0 | 1,722 |
| Total, all-cause mortality | Placebo | 0 | 1,689 |
| Total, other adverse events | M-M-R II ® | 0 | 1,722 |
| Total, other adverse events | Placebo | 0 | 1,689 |
| Total, serious adverse events | M-M-R II ® | 11 | 1,722 |
| Total, serious adverse events | Placebo | 5 | 1,689 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| M-M-R II ® vs Placebo: Number of Participants With Symptomatic COVID-19 at 60 Days | Trial comparisons |
| M-M-R II ® vs Placebo: Number of Participants With Symptomatic COVID-19 at 150 Days | Trial comparisons |
| M-M-R II ® vs Placebo: Risk of SARS-CoV-2 Infection up to 150 Days After Trial Intervention | Trial comparisons |
| M-M-R II ® vs Placebo: Severity of COVID-19 Measured at 60 Days After Intervention | Trial comparisons |
| M-M-R II ® vs Placebo: Severity of COVID-19 at 150 Days After Intervention | Trial comparisons |
| M-M-R II ® vs Placebo: deaths from any cause | Trial comparisons |
| M-M-R II ® vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04333732
GET https://conductscience.org/api/trials/v1/NCT04333732/events?page=2