| Primary | Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) During the EAP | 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. | 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 | Posted | | Number | | Percentage of Participants | | Up to 1 month | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Placebo of R10933 + R10987 | Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG001 | Cohort A: R10933 + R10987 | Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline |
| | | Title | Denominators | Categories |
|---|
| | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Regression, Logistic | | < 0.0001 | | Odds Ratio (OR) | 0.17 | | | 2-Sided | 95 | 0.090 | 0.332 | | | | | Superiority | | |
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| 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 | 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). | Estimate of percent of participants meeting the criteria based on fixed categories | Posted | | Number | | Percentage of Participants | | Up to 14 Days | | | | ID | Title | Description |
|---|
| OG000 | Cohort B: Placebo of R10933 + R10987 | Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive | | OG001 | Cohort B: R10933 + R10987 | Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive |
| |
| Primary | Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs | | | Posted | | Count of Participants | | Participants | | Up to 8 months | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Placebo of R10933 + R10987 | Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG001 | Cohort A: R10933 + R10987 | Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG002 | Cohort B: Placebo of R10933 + R10987 | Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive | | OG003 | Cohort B: R10933 + R10987 | Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive |
| |
| Secondary | Cohort A and Cohort B: Percentage of Participants With High Viral Load in Nasopharyngeal (NP) Swab Samples During the EAP | High viral load (> 4 log 10 copies/ml) | | Posted | | Number | | Percentage of Participants | | Up to 1 month | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Placebo of R10933 + R10987 | Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG001 | Cohort A: R10933 + R10987 | Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG002 | Cohort B: Placebo of R10933 + R10987 | Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive | | OG003 | Cohort B: R10933 + R10987 | Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive |
| |
| Secondary | Cohort A: Number of Weeks of Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad Term) During the EAP | | | Posted | | Mean | Standard Deviation | weeks | | Up to 1 month | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Placebo of R10933 + R10987 | Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG001 | Cohort A: R10933 + R10987 | Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline |
| |
| Secondary | Cohort A and Cohort B: Number of Weeks of High Viral Load in NP Swab Samples During the EAP | High viral load (> 4 log 10 copies/ml) | | Posted | | Mean | Standard Deviation | weeks | | Up to 1 month | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Placebo of R10933 + R10987 | Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG001 | Cohort A: R10933 + R10987 | Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG002 | Cohort B: Placebo of R10933 + R10987 | Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive | | OG003 | Cohort B: R10933 + R10987 | Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive |
| |
| Secondary | Cohort A: Number of Weeks of RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP | | | Posted | | Mean | Standard Deviation | weeks | | Up to 1 month | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Placebo of R10933 + R10987 | Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG001 | Cohort A: R10933 + R10987 | Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline |
| |
| Secondary | Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP | 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) | Estimate of percentage of participants meeting the criteria based on fixed categories | Posted | | Number | | Percentage of Participants | | Up to 1 month | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Placebo of R10933 + R10987 | Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG001 | Cohort A: R10933 + R10987 | Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline |
| |
| 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) | | | Posted | | Number | | Percentage of Participants | | Up to 1 month | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Placebo of R10933 + R10987 | Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline |
| | |
| Secondary | Cohort A: Percentage of Participants With a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (CDC Definition) During the EAP | 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. | | Posted | | Number | | Percentage of participants | | Up to 1 month | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Placebo of R10933 + R10987 | Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG001 | Cohort A: R10933 + R10987 | Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline |
| |
| Secondary | Cohort A: Number of Weeks of Symptomatic RT-qPCR-confirmed SARS-CoV-2 Infection (CDC Definition) During the EAP | | | Posted | | Mean | Standard Deviation | weeks | | Up to 1 month | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Placebo of R10933 + R10987 | Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG001 | Cohort A: R10933 + R10987 | Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline |
| |
| Secondary | Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Strict-term) During the EAP | 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) | Estimate of percentage of participants meeting the criteria based on fixed categories | Posted | | Number | | Percentage of participants | | Up to 1 month | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Placebo of R10933 + R10987 | Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG001 | Cohort A: R10933 + R10987 | Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline |
| |
| Secondary | Cohort A: Number of Weeks of Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Strict-term) During the EAP | | | Posted | | Mean | Standard Deviation | weeks | | Up to 1 month | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Placebo of R10933 + R10987 | Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG001 | Cohort A: R10933 + R10987 | Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline |
| |
| Secondary | Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infections at Each Week in the EAP | | | Posted | | Number | | Percentage of participants | | Week 1, Week 2, Week 3, Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Placebo of R10933 + R10987 | Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG001 | Cohort A: R10933 + R10987 | Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline |
| |
| Secondary | Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) at Each Week in the EAP | 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) | Estimate of percentage of participants meeting the criteria based on fixed categories | Posted | | Number | | Percentage of participants | | Week 1, Week 2, Week 3, Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Placebo of R10933 + R10987 | Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG001 | Cohort A: R10933 + R10987 | Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline |
| |
| Secondary | Cohort A: Time-weighted Average of Viral Load From the First Positive SARS CoV-2 RT-qPCR in NP Swab Samples (That Has an Onset During the EAP) Until the Third Weekly Visit After the First Positive Test During the EAP | | | Posted | | Least Squares Mean | Standard Error | log10 copies/mL | | Up to 1 month | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Placebo of R10933 + R10987 | Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG001 | Cohort A: R10933 + R10987 | Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline |
| |
| Secondary | Cohort A: Time-weighted Average of Viral Load From the First Positive SARS-CoV-2 RT-qPCR in NP Swab Samples (That Has an Onset During the EAP) Until the Second Weekly Visit After the First Positive Test During the EAP | | | Posted | | Least Squares Mean | Standard Error | log10 copies/mL | | Up to 1 month | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Placebo of R10933 + R10987 | Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG001 | Cohort A: R10933 + R10987 | Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline |
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| Secondary | Cohort A: Maximum SARS-CoV-2 RT-qPCR Viral Load in NP Swab Samples Among Individuals With ≥1 RT-qPCR Positive That Has an Onset During the EAP | | | Posted | | Least Squares Mean | Standard Error | log10 copies/mL | | Up to 1 month | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Placebo of R10933 + R10987 | Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG001 | Cohort A: R10933 + R10987 | Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline |
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| Secondary | Cohort A: SARS-CoV-2 RT-qPCR Viral Load in NP Swab Samples Corresponding to the Onset of First Positive RT-qPCR During the EAP | | | Posted | | Least Squares Mean | Standard Error | log10 copies/mL | | Up to 1 month | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Placebo of R10933 + R10987 | Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG001 | Cohort A: R10933 + R10987 | Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline |
| |
| Secondary | Cohort A: Area Under the Curve (AUC) in Viral Load From the First Positive SARS-CoV-2 RT-qPCR NP Swab Samples Detected During the EAP Until the First Confirmed Negative Test | | | Posted | | Mean | Standard Deviation | log10 copies/milliLiter * days | | Up to 1 month | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Placebo of R10933 + R10987 | Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG001 | Cohort A: R10933 + R10987 | Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline |
| |
| Secondary | Cohort A: Total Number of Medically Attended Visits in Emergency Rooms or Urgent Care Centers Related to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP | Medically attended visits referred to hospitalizations, Emergency Room visits, or visits at an Urgent Care center. | | Posted | | Number | | medically attended visits | | Up to 1 month | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Placebo of R10933 + R10987 | Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG001 | Cohort A: R10933 + R10987 | Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline |
| |
| Secondary | Cohort A: Percentage of Participants With at Least 1 COVID-19-related Hospitalization or Emergency Room Visit Associated With a Positive RT-qPCR During the EAP or All-cause Death | | | Posted | | Number | | Percentage of Participants | | Up to 1 month | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Placebo of R10933 + R10987 | Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG001 | Cohort A: R10933 + R10987 | Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline |
| |
| Secondary | Cohort A: Percentage of Participants Requiring Medically Attended Visits in Emergency Rooms or Urgent Care Centers Related to a RT-qPCR Confirmed SARS CoV-2 Infection That Has an Onset During the EAP | | | Posted | | Number | | Percentage of participants | | Up to 1 month | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Placebo of R10933 + R10987 | Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG001 | Cohort A: R10933 + R10987 | Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline |
| |
| Secondary | Cohort A: Proportion of Participants Hospitalized Related to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP | The proportion of participants hospitalized related to a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP | Estimate of proportion of participants meeting the criteria based on fixed categories | Posted | | Number | | Proportion of Participants | | Up to 14 Days | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Placebo of R10933 + R10987 | Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG001 | Cohort A: R10933 + R10987 | Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline |
| |
| Secondary | Cohort A: Number of Days of Hospital and Intensive Care Unit (ICU) Stay in Participants Hospitalized for a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP | | Only 1 participant in placebo group hospitalized | Posted | | Number | | Days | | Up to Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Placebo of R10933 + R10987 | Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG001 | Cohort A: R10933 + R10987 | Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline |
| |
| Secondary | Cohort A: Number of Days Missed for Daily Responsibilities Due to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP | Daily responsibilities including work (employed adults) or school (students), daycare or family obligations/responsibilities (childcare or eldercare) | | Posted | | Mean | Standard Deviation | days | | Up to 1 month | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Placebo of R10933 + R10987 | Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG001 | Cohort A: R10933 + R10987 | Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline |
| |
| Secondary | Cohort A: Proportion of Baseline Seropositive Participants (Based on Central Lab Test) With TEAEs and Severity of TEAEs | | | Posted | | Count of Participants | | Participants | | Up to 8 months | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Placebo of R10933 + R10987 | Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG001 | Cohort A: R10933 + R10987 | Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline |
| |
| Secondary | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP | | | Posted | | Count of Participants | | Participants | | Up to Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Placebo of R10933 + R10987 | Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG001 | Cohort A: R10933 + R10987 | Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG002 | Cohort B: Placebo of R10933 + R10987 | Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive | | OG003 | Cohort B: R10933 + R10987 | Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive |
| |
| Secondary | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period | | | Posted | | Count of Participants | | Participants | | Day 30 Up to Day 225 (Approximately 8 months) | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Placebo of R10933 + R10987 | Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG001 | Cohort A: R10933 + R10987 | Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG002 | Cohort B: Placebo of R10933 + R10987 | Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive | | OG003 | Cohort B: R10933 + R10987 | Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive |
| |
| Secondary | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP | | | Posted | | Count of Participants | | Participants | | Up to Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Placebo of R10933 + R10987 | Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG001 | Cohort A: R10933 + R10987 | Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG002 | Cohort B: Placebo of R10933 + R10987 | Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive | | OG003 | Cohort B: R10933 + R10987 | Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive |
| |
| Secondary | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period | | | Posted | | Count of Participants | | Participants | | Day 30 Up to Day 225 (Approximately 8 months) | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Placebo of R10933 + R10987 | Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG001 | Cohort A: R10933 + R10987 | Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG002 | Cohort B: Placebo of R10933 + R10987 | Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive | | OG003 | Cohort B: R10933 + R10987 | Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive |
| |
| Secondary | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP | | | Posted | | Count of Participants | | Participants | | Up to Day 29 | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Placebo of R10933 + R10987 | Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG001 | Cohort A: R10933 + R10987 | Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG002 | Cohort B: Placebo of R10933 + R10987 | Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive | | OG003 | Cohort B: R10933 + R10987 | Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive |
| |
| Secondary | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period | | | Posted | | Count of Participants | | Participants | | Day 30 Up to Day 225 (Approximately 8 months) | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: Placebo of R10933 + R10987 | Cohort A: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG001 | Cohort A: R10933 + R10987 | Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG002 | Cohort B: Placebo of R10933 + R10987 | Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive | | OG003 | Cohort B: R10933 + R10987 | Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive |
| |
| Secondary | Cohort B: Number of Weeks of Symptomatic SARS-CoV-2 Infection (Broad-term) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP | | | Posted | | Mean | Standard Deviation | weeks | | Up to 14 Days | | | | ID | Title | Description |
|---|
| OG000 | Cohort B: Placebo of R10933 + R10987 | Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive | | OG001 | Cohort B: R10933 + R10987 | Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive |
| |
| Secondary | Cohort B: Percentage of Participants With Asymptomatic Infection Who Develop Signs and Symptoms (CDC Definition) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP | 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) | Estimate of percentage of participants meeting the criteria based on fixed categories | Posted | | Number | | percentage of participants | | Up to 1 month | | | | ID | Title | Description |
|---|
| OG000 | Cohort B: Placebo of R10933 + R10987 | Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive | | OG001 | Cohort B: R10933 + R10987 | Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive |
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| Secondary | Cohort B: Percentage of Participants Who Subsequently Develop Signs and Symptoms (Strict-term) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP | 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) | Estimate of percentage of participants meeting the criteria based on fixed categories | Posted | | Number | | Percentage of Participants | | Up to 14 Days | | | | ID | Title | Description |
|---|
| OG000 | Cohort B: Placebo of R10933 + R10987 | Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive | | OG001 | Cohort B: R10933 + R10987 | Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive |
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| Secondary | Cohort B: Number of Weeks of Symptomatic SARS-CoV-2 Infection (CDC Definition) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP | | | Posted | | Mean | Standard Deviation | weeks | | Up to 14 Days | | | | ID | Title | Description |
|---|
| OG000 | Cohort B: Placebo of R10933 + R10987 | Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive | | OG001 | Cohort B: R10933 + R10987 | Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive |
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| Secondary | Cohort B: Number of Weeks of Symptomatic SARS-CoV-2 Infection (Strict-term Definition) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP | | | Posted | | Mean | Standard Deviation | weeks | | Up to 14 Days | | | | ID | Title | Description |
|---|
| OG000 | Cohort B: Placebo of R10933 + R10987 | Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive | | OG001 | Cohort B: R10933 + R10987 | Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive |
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| Secondary | Cohort B: Change in Viral Load From Baseline to Day 8 Visit in NP Swab Samples | | | Posted | | Least Squares Mean | Standard Error | log10 copies/mL | | Up to day 8 visit | | | | ID | Title | Description |
|---|
| OG000 | Cohort B: Placebo of R10933 + R10987 | Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive | | OG001 | Cohort B: R10933 + R10987 | Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive |
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| Secondary | Cohort B: Change in Viral Load From Baseline to Day 15 Visit in NP Swab Samples | | | Posted | | Least Squares Mean | Standard Error | log10 copies/mL | | Up to day 15 visit | | | | ID | Title | Description |
|---|
| OG000 | Cohort B: Placebo of R10933 + R10987 | Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive | | OG001 | Cohort B: R10933 + R10987 | Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive |
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| Secondary | Cohort B: Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) in NP Swab Samples Until the Day 22 Visit | | | Posted | | Least Squares Mean | Standard Error | log10 copies/mL | | Day 22 | | | | ID | Title | Description |
|---|
| OG000 | Cohort B: Placebo of R10933 + R10987 | Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive | | OG001 | Cohort B: R10933 + R10987 | Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive |
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| Secondary | Cohort B: AUC in Viral Load From the First Positive SARS-CoV-2 RT-qPCR NP Swab Samples Detected During the EAP to the First Confirmed Negative Test | | | Posted | | Least Squares Mean | Standard Error | log10 copies/milliLiter*days | | Up to 14 Days | | | | ID | Title | Description |
|---|
| OG000 | Cohort B: Placebo of R10933 + R10987 | Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive | | OG001 | Cohort B: R10933 + R10987 | Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive |
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| Secondary | Cohort B: Maximum SARS-CoV-2 RT-qPCR Viral Load in NP Swab Samples in Participants With 1 or More Positive Test That Has an Onset During the EAP | | | Posted | | Least Squares Mean | Standard Error | log10 copies/mL | | Up to 1 month | | | | ID | Title | Description |
|---|
| OG000 | Cohort B: Placebo of R10933 + R10987 | Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive | | OG001 | Cohort B: R10933 + R10987 | Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive |
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| Secondary | Cohort B: Number of Medically Attended Visits in Emergency Rooms or Urgent Care Centers Related to RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset at Baseline or During the EAP | | | Posted | | Mean | Standard Deviation | Medically attended visits | | Up to 1 month | | | | ID | Title | Description |
|---|
| OG000 | Cohort B: Placebo of R10933 + R10987 | Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive | | OG001 | Cohort B: R10933 + R10987 | Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive |
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| Secondary | Cohort B: Percentage of Participants Requiring Medically Attended Visits in Emergency Rooms or Urgent Care Centers Related to a RT-qPCR Confirmed SARS CoV-2 Infection That Has an Onset at Baseline or During the EAP | | | Posted | | Number | | Percentage of participants | | Up to 1 month | | | | ID | Title | Description |
|---|
| OG000 | Cohort B: Placebo of R10933 + R10987 | Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive | | OG001 | Cohort B: R10933 + R10987 | Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive |
| |
| Secondary | Cohort B: Percentage of Participants Hospitalized Related to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset at Baseline or During the EAP | | | Posted | | Number | | Percentage of participants | | Up to 14 Days | | | | ID | Title | Description |
|---|
| OG000 | Cohort B: Placebo of R10933 + R10987 | Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive | | OG001 | Cohort B: R10933 + R10987 | Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive |
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| Secondary | Cohort B: Number of Days Missed for Daily Responsibilities (Where Applicable) Due to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset at Baseline or During the EAP | | | Posted | | Mean | Standard Deviation | Days | | Up to 1 month | | | | ID | Title | Description |
|---|
| OG000 | Cohort B: Placebo of R10933 + R10987 | Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive | | OG001 | Cohort B: R10933 + R10987 | Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive |
| |
| Secondary | Cohort B: Number of Days of Hospital and Intensive Care Unit (ICU) Stay in Participants Hospitalized for a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset at Baseline or During the EAP | | Estimate of proportion of participants meeting the criteria | Posted | | Mean | Standard Deviation | days | | Up to 1 month | | | | ID | Title | Description |
|---|
| OG000 | Cohort B: Placebo of R10933 + R10987 | Cohort B: Placebo of R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR Positive | | OG001 | Cohort B: R10933 + R10987 | Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive |
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| Secondary | Concentrations of REGN10987 in Serum Over Time (Cohort A) | | Number of participants in Cohort A with reportable concentrations obtained from baseline to day 112 of study for REGN10987 only. This PK analysis set (PKAS: Safety Subset) includes all treated subjects who received any study drug and had at least 1 non-missing imdevimab measurement following study drug administration. The PK analysis safety subset is based on the actual treatment received (as treated) rather than as randomized | Posted | | Mean | Standard Deviation | milligrams per Liter (mg/L) | | 0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: R10933 + R10987 | Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline |
| |
| Secondary | Concentrations of REGN10987 in Serum Over Time (Cohort B) | | Number of participants in Cohort B with reportable concentrations obtained from baseline to day 112 of study for REGN10987 only. This PK analysis set (PKAS: Safety Subset) includes all treated subjects who received any study drug and had at least 1 non-missing imdevimab measurement following study drug administration. The PK analysis safety subset is based on the actual treatment received (as treated) rather than as randomized | Posted | | Mean | Standard Deviation | milligrams per Liter (mg/L) | | 0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose | | | | ID | Title | Description |
|---|
| OG000 | Cohort B: R10933 + R10987 | Cohort B: R10933 + R10987 Adult and Adolescent Participants (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline |
| |
| Secondary | Concentrations of REGN10933 in Serum Over Time (Cohort A) | | Number of participants in Cohort A with reportable concentrations obtained from baseline to day 112 of study for REGN10933 only. This PK analysis set (PKAS: Safety Subset) includes all treated subjects who received any study drug and had at least 1 non-missing imdevimab measurement following study drug administration. The PK analysis safety subset is based on the actual treatment received (as treated) rather than as randomized | Posted | | Mean | Standard Deviation | milligrams per Liter (mg/L) | | 0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose | | | | ID | Title | Description |
|---|
| OG000 | Cohort A: R10933 + R10987 | Cohort A: R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline |
| |
| Secondary | Concentrations of REGN10933 in Serum Over Time (Cohort B) | | Number of participants in Cohort B with reportable concentrations obtained from baseline to day 112 of study for REGN10933 only. This PK analysis set (PKAS: Safety Subset) includes all treated subjects who received any study drug and had at least 1 non-missing imdevimab measurement following study drug administration. The PK analysis safety subset is based on the actual treatment received (as treated) rather than as randomized | Posted | | Mean | Standard Deviation | milligrams per Liter (mg/L) | | 0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose | | | | ID | Title | Description |
|---|
| OG000 | Cohort B: R10933 + R10987 | Cohort B: R10933 + R10987 Adult and Adolescent Participants (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline |
| |
| Secondary | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 | | This ADA analysis set (AAS) includes all treated subjects who received study drug and had at least 1 non-missing ADA result after study drug administration. The AAS is based on the actual treatment received. | Posted | | Count of Participants | | Participants | | Up to 8 months | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Overall Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG001 | R10933 + R10987 | Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 |
| |
| Secondary | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 | | This ADA analysis set (AAS) includes all treated subjects who received study drug and had at least 1 non-missing ADA result after study drug administration. The AAS is based on the actual treatment received. | Posted | | Count of Participants | | Participants | | Up to 8 months | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Overall Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG001 | R10987 +R10933 | Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 |
| |
| Secondary | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933 | (TE&TB+;NAb+) = TE = Treatment-Emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay | This ADA analysis set (AAS) includes all treated participants who received study drug and had at least 1 non-missing ADA result after study drug administration. The AAS is based on the actual treatment received. | Posted | | Count of Participants | | Participants | | Up to 8 months | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Overall Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG001 | R10933 + R10987 | Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 |
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| Secondary | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 | (TE&TB+;NAb+) = TE = Treatment-emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay | This ADA analysis set (AAS) includes all treated subjects who received study drug and had at least 1 non-missing ADA result after study drug administration. The AAS is based on the actual treatment received. | Posted | | Count of Participants | | Participants | | Up to 8 Months | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Overall Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | | OG001 | R10987 + R10987 | Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 |
| |