Trial · NCT04452318
COVID-19 Study Assessing the Efficacy and Safety of Anti-Spike SARS CoV-2 Monoclonal Antibodies for Prevention of SARS CoV-2 Infection Asymptomatic in Healthy Adults and Adolescents Who Are Household Contacts to an Individual With a Positive SARS-CoV-2 RT-PCR Assay
NCT04452318, Phase 3, Completed, Regeneron Pharmaceuticals; results first posted 2023-05-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. COVID-19 Study Assessing the Efficacy and Safety of Anti-Spike SARS CoV-2 Monoclonal Antibodies for Prevention of SARS CoV-2 Infection Asymptomatic in Healthy Adults and Adolescents Who Are Household Contacts to an Individual With a Positive SARS-CoV-2 RT-PCR Assay. Trials, record NCT04452318. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04452318
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
COVID-19 Study Assessing the Efficacy and Safety of Anti-Spike SARS CoV-2 Monoclonal Antibodies for Prevention of SARS CoV-2 Infection Asymptomatic in Healthy Adults and Adolescents Who Are Household Contacts to an Individual With a Positive SARS-CoV-2 RT-PCR Assay
- NCT number
- NCT04452318
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,303 participants, actual
- Lead sponsor
- Regeneron Pharmaceuticals
- Conditions
- Healthy Participants
- Interventions
- REGN10933 + REGN10987, Placebo
- First posted
- 2020-06-30
- Last updated
- 2023-05-15
- Other registries' IDs
- eudract:2020-003654-71
- Results first posted
- 2023-05-15
Source ClinicalTrials.gov
Registered outcomes56
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) During the EAP | Up to 1 month | Symptomatic SARS-CoV-2 infection (broad-term) is defined as a positive central lab SARS-CoV-2 RT-qPCR result (either NP, nasal or saliva) associated with signs and symptoms with the onset date occurring within 14 days of a positive RT-qPCR during the EAP. Percentage estimated by Logistic Regression. |
| Primary | Cohort B: Percentage of Participants Who Subsequently Develop Signs and Symptoms (Broad-Term) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP | Up to 14 Days | The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:\>=12 to=50), and region (US vs ex-US). |
| Primary | Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs | Up to 8 months | |
| Secondary | Cohort A and Cohort B: Percentage of Participants With High Viral Load in Nasopharyngeal (NP) Swab Samples During the EAP | Up to 1 month | High viral load (\> 4 log 10 copies/ml) |
| Secondary | Cohort A: Number of Weeks of Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad Term) During the EAP | Up to 1 month | |
| Secondary | Cohort A and Cohort B: Number of Weeks of High Viral Load in NP Swab Samples During the EAP | Up to 1 month | High viral load (\> 4 log 10 copies/ml) |
| Secondary | Cohort A: Number of Weeks of RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP | Up to 1 month | |
| Secondary | Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP | Up to 1 month | The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:\>=12 to=50), and region (US vs ex-US) |
| Secondary | Cohort A: Percentage of Participants in Placebo Group With a RT-qPCR Confirmed SARS-CoV-2 Infection During the EAP With an Index Case Participating in Study R10933-10987-COV-2067 (NCT04425629) | Up to 1 month | |
| Secondary | Cohort A: Percentage of Participants With a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (CDC Definition) During the EAP | Up to 1 month | Symptomatic SARS-CoV-2 infection (CDC definition) is defined as a positive central lab SARS-CoV-2 RT-qPCR result (either NP, nasal or saliva) associated with signs and symptoms with the onset date occurring within 14 days of a positive RT-qPCR during the EAP. Percentage estimated by Logistic Regression. |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 registered outcomesOutcomes56
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) During the EAP | Up to 1 month | Seronegative modified full analysis set in Cohort A includes randomized subjects aged 12 years and older who are laboratory confirmed negative for SARS-CoV-2 and negative serostatus for SAS-CoV-2 antibodies at baseline | Percentage of Participants | NUMBER |
| PRIMARY | Cohort B: Percentage of Participants Who Subsequently Develop Signs and Symptoms (Broad-Term) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP | Up to 14 Days | Estimate of percent of participants meeting the criteria based on fixed categories | Percentage of Participants | NUMBER |
| PRIMARY | Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs | Up to 8 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Cohort A and Cohort B: Percentage of Participants With High Viral Load in Nasopharyngeal (NP) Swab Samples During the EAP | Up to 1 month | Percentage of Participants | NUMBER | |
| SECONDARY | Cohort A: Number of Weeks of Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad Term) During the EAP | Up to 1 month | weeks | MEAN | |
| SECONDARY | Cohort A and Cohort B: Number of Weeks of High Viral Load in NP Swab Samples During the EAP | Up to 1 month | weeks | MEAN | |
| SECONDARY | Cohort A: Number of Weeks of RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP | Up to 1 month | weeks | MEAN | |
| SECONDARY | Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP | Up to 1 month | Estimate of percentage of participants meeting the criteria based on fixed categories | Percentage of Participants | NUMBER |
| SECONDARY | Cohort A: Percentage of Participants in Placebo Group With a RT-qPCR Confirmed SARS-CoV-2 Infection During the EAP With an Index Case Participating in Study R10933-10987-COV-2067 (NCT04425629) | Up to 1 month | Percentage of Participants | NUMBER | |
| SECONDARY | Cohort A: Percentage of Participants With a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (CDC Definition) During the EAP | Up to 1 month | Percentage of participants | NUMBER |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 outcomesResults by group292
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) During the EAP | Cohort A: Placebo of R10933 + R10987 | 7.8 | Percentage of Participants | ||
| Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) During the EAP | Cohort A: R10933 + R10987 | 1.4 | Percentage of Participants | ||
| Cohort B: Percentage of Participants Who Subsequently Develop Signs and Symptoms (Broad-Term) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP | Cohort B: Placebo of R10933 + R10987 | 42.5 | Percentage of Participants | ||
| Cohort B: Percentage of Participants Who Subsequently Develop Signs and Symptoms (Broad-Term) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP | Cohort B: R10933 + R10987 | 28.4 | Percentage of Participants | ||
| Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs | Cohort A: Placebo of R10933 + R10987 | # of participants with at least one TEAE | 512 | Participants | |
| Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs | Cohort A: R10933 + R10987 | # of participants with at least one TEAE | 405 | Participants | |
| Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs | Cohort B: Placebo of R10933 + R10987 | # of participants with at least one TEAE | 88 | Participants | |
| Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs | Cohort B: R10933 + R10987 | # of participants with at least one TEAE | 60 | Participants | |
| Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs | Cohort A: Placebo of R10933 + R10987 | # of participants with at least one Grade 1 TEAE | 384 | Participants | |
| Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs | Cohort A: R10933 + R10987 | # of participants with at least one Grade 1 TEAE | 284 | Participants |
1 to 10 of 292Source ClinicalTrials.gov
See all 292 results by groupParticipant flow28
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A: Placebo of R10933 + R10987 | 1,430 | |
| Overall Study | STARTED | R10933 + R10987 | 1,441 | |
| Overall Study | STARTED | Cohort A1: Placebo of R10933 + R10987 | 1 | |
| Overall Study | STARTED | Cohort B: Placebo of R10933 + R10987 | 173 | |
| Overall Study | STARTED | Cohort B: R10933 + R10987 | 166 | |
| Overall Study | STARTED | Undetermined: Placebo of R10933 + R10987 | 53 | |
| Overall Study | STARTED | Undetermined: R10933 + R10987 | 34 | |
| Overall Study | Randomized and Treated | Cohort A: Placebo of R10933 + R10987 | 1,428 | |
| Overall Study | Randomized and Treated | R10933 + R10987 | 1,439 | |
| Overall Study | Randomized and Treated | Cohort A1: Placebo of R10933 + R10987 | 1 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 participant flowAdverse events343
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 |
|---|---|---|---|---|---|---|
| other | COVID-19 | Infections and infestations | Cohort A Placebo | 148 | 1,428 | 149 |
| other | COVID-19 | Infections and infestations | Cohort A R10933+R10987 | 29 | 1,439 | 32 |
| other | COVID-19 | Infections and infestations | Cohort A1 Placebo | 0 | 1 | 0 |
| other | COVID-19 | Infections and infestations | Cohort B Placebo | 58 | 170 | 59 |
| other | COVID-19 | Infections and infestations | Cohort B R10933+R10987 | 35 | 165 | 35 |
| other | COVID-19 | Infections and infestations | Undetermined Placebo | 4 | 44 | 4 |
| other | COVID-19 | Infections and infestations | Undetermined R10933+R10987 | 1 | 23 | 1 |
| other | Asymptomatic COVID-19 | Infections and infestations | Cohort A Placebo | 119 | 1,428 | 119 |
| other | Asymptomatic COVID-19 | Infections and infestations | Cohort A R10933+R10987 | 71 | 1,439 | 73 |
| other | Asymptomatic COVID-19 | Infections and infestations | Cohort A1 Placebo | 0 | 1 | 0 |
1 to 10 of 343Source ClinicalTrials.gov
See all 343 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A Placebo | 2 | 1,428 |
| Total, all-cause mortality | Cohort A R10933+R10987 | 3 | 1,439 |
| Total, all-cause mortality | Cohort A1 Placebo | 0 | 1 |
| Total, all-cause mortality | Cohort B Placebo | 0 | 170 |
| Total, all-cause mortality | Cohort B R10933+R10987 | 0 | 165 |
| Total, all-cause mortality | Undetermined Placebo | 0 | 44 |
| Total, all-cause mortality | Undetermined R10933+R10987 | 0 | 23 |
| Total, other adverse events | Cohort A Placebo | 247 | 1,428 |
| Total, other adverse events | Cohort A R10933+R10987 | 96 | 1,439 |
| Total, other adverse events | Cohort A1 Placebo | 0 | 1 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers8
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| R10933 + R10987 vs Placebo: Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 | Trial comparisons |
| R10987 + R10987 vs Placebo: Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 | Trial comparisons |
| R10987 +R10933 vs Placebo: Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 | Trial comparisons |
| R10933 + R10987 vs Placebo: Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933 | 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/NCT04452318
GET https://conductscience.org/api/trials/v1/NCT04452318/registered?page=2