Healthy Participants
Conditions
Keywords
Asymptomatic, Individuals at risk of exposure to SARS-CoV-2, Household Contacts of a Person Infected with SARS-CoV-2
Brief summary
Primary Objectives: Cohort A: • To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing symptomatic SARS-CoV-2 infection (broad-term) confirmed by RT-qPCR Cohort A and Cohort A1: • To evaluate the safety and tolerability of REGN10933+REGN10987 following subcutaneous (SC) administration compared to placebo Cohort B • To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing COVID-19 symptoms (broad-term) Cohort B and Cohort B1 • To evaluate the safety and tolerability of REGN10933+REGN10987 following SC administration compared to placebo
Detailed description
Cohort A: adult and adolescent subjects (≥12 years) who are SARS -CoV-2 RT-qPCR negative at baseline Cohort A1: pediatric subjects (\<12 years) who are SARS-CoV-2 RT--qPCR negative at baseline Cohort B: adult and adolescent subjects (≥12 years) who are SARS -CoV-2 RT-qPCR positive at baseline Cohort B1: pediatric subjects (\<12 years) who are SARS-CoV-2 RT--qPCR positive at baseline
Interventions
DRUGREGN10933 + REGN10987
Subcutaneous (SC) or Intramuscular (IM) injections
DRUGPlacebo
SC or IM injections
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to No maximum
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: 1. Adult subjects 18 years of age (irrespective of weight) and above at the signing of informed consent or adolescent participants ≥12 to \<18 years of age, or pediatric participants \<12 years of age at the signing of the assent (parent/guardian sign the informed consent) 2. Asymptomatic household contact with exposure to an individual with a diagnosis of SARS-CoV-2 infection (index case). To be included in the study, participants must be randomized within 96 hours of collection of the index cases' positive SARS-COV-2 diagnostic test sample 3. Participant anticipates living in the same household with the index case until study day 29 4. Is judged by the investigator to be in good health based on medical history and physical examination at screening/baseline, including participants who are healthy or have a chronic, stable medical condition 5. Willing and able to comply with study visits and study-related procedures/assessments. 6. Provide informed consent signed by study participant or legally acceptable representative. Key
Exclusion criteria
1. History of prior positive SARS-CoV-2 RT-PCR test or positive SARS-CoV-2 serology test at any time before the screening 2. Participant has lived with individuals who have had previous SARS-CoV-2 infection or currently lives with individuals who have SARS-CoV-2 infection, with the exception of the index case(s), the first individual(s) known to be infected in the household 3. Active respiratory or non-respiratory symptoms consistent with COVID-19 4. History of respiratory illness with sign/symptoms of SARS-CoV-2 infection, in the opinion of the investigator, within the prior 6 months to screening 5. Nursing home resident 6. Any physical examination findings, and/or history of any illness, concomitant medications or recent live vaccines that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the participant by their participation in the study Note: Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Cohort A: Number of Weeks of RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP | Up to 1 month | — |
| 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) |
| 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 | — |
| 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. |
| Cohort A: Number of Weeks of Symptomatic RT-qPCR-confirmed SARS-CoV-2 Infection (CDC Definition) During the EAP | Up to 1 month | — |
| Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Strict-term) 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) |
| Cohort A: Number of Weeks of Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Strict-term) During the EAP | Up to 1 month | — |
| Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infections at Each Week in the EAP | Week 1, Week 2, Week 3, Week 4 | — |
| Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) at Each Week in the EAP | Week 1, Week 2, Week 3, Week 4 | 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) |
| 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 | Up to 1 month | — |
| 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 | Up to 1 month | — |
| 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 | Up to 1 month | — |
| 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 | Up to 1 month | — |
| 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 | Up to 1 month | — |
| 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 | Up to 1 month | Medically attended visits referred to hospitalizations, Emergency Room visits, or visits at an Urgent Care center. |
| 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 | Up to 1 month | — |
| 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 | Up to 1 month | — |
| Cohort A: Proportion of Participants Hospitalized Related to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP | Up to 14 Days | The proportion of participants hospitalized related to a RT-qPCR confirmed SARS-CoV-2 infection that has an onset during the EAP |
| 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 | Up to Day 29 | — |
| 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 | Up to 1 month | Daily responsibilities including work (employed adults) or school (students), daycare or family obligations/responsibilities (childcare or eldercare) |
| Cohort A: Proportion of Baseline Seropositive Participants (Based on Central Lab Test) With TEAEs and Severity of TEAEs | Up to 8 months | — |
| Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP | Up to Day 29 | — |
| Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period | Day 30 Up to Day 225 (Approximately 8 months) | — |
| Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP | Up to Day 29 | — |
| Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period | Day 30 Up to Day 225 (Approximately 8 months) | — |
| Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP | Up to Day 29 | — |
| Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period | Day 30 Up to Day 225 (Approximately 8 months) | — |
| 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 | Up to 14 Days | — |
| 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 | 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) |
| 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 | 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) |
| 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 | Up to 14 Days | — |
| 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 | Up to 14 Days | — |
| Cohort B: Change in Viral Load From Baseline to Day 8 Visit in NP Swab Samples | Up to day 8 visit | — |
| Cohort B: Change in Viral Load From Baseline to Day 15 Visit in NP Swab Samples | Up to day 15 visit | — |
| Cohort B: Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) in NP Swab Samples Until the Day 22 Visit | Day 22 | — |
| 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 | Up to 14 Days | — |
| 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 | Up to 1 month | — |
| 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 | Up to 1 month | — |
| 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 | Up to 1 month | — |
| 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 | Up to 14 Days | — |
| 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 | Up to 1 month | — |
| 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 | Up to 1 month | — |
| Concentrations of REGN10987 in Serum Over Time (Cohort A) | 0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose | — |
| Concentrations of REGN10987 in Serum Over Time (Cohort B) | 0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose | — |
| Concentrations of REGN10933 in Serum Over Time (Cohort A) | 0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose | — |
| 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) |
| Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 | Up to 8 months | — |
| Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 | Up to 8 months | — |
| Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933 | Up to 8 months | (TE&TB+;NAb+) = TE = Treatment-Emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay |
| Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 | Up to 8 Months | (TE&TB+;NAb+) = TE = Treatment-emergent; TB = Treatment-boosted; NAb+ = Positive in NAb assay |
| Concentrations of REGN10933 in Serum Over Time (Cohort B) | 0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose | — |
| Cohort A: Number of Weeks of Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad Term) During the EAP | Up to 1 month | — |
| 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) |
Countries
Moldova, Romania, United States
Participant flow
Pre-assignment details
Of 3375 participants screened, 3298 participants were randomized and 3270 participants were treated. 77 participants were screen failures and 28 participants were randomized but not treated.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 1,430 |
| R10933 + R10987 R10933 + R10987 Adult and Adolescent Subjects (≥12years) Who Are SARS-CoV-2 RT-qPCR negative at baseline | 1,441 |
| Cohort A1: Placebo of R10933 + R10987 Cohort A1: Placebo of R10933 + R10987 Pediatric Subjects (\<12 years) with SARS-CoV-2 RT-qPCR Negative | 1 |
| 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 | 173 |
| Cohort B: R10933 + R10987 Cohort B: R10933 + R10987 Adult and Adolescent Subjects (≥12years) who Are SARS-CoV-2 RT-qPCR Positive | 166 |
| Undetermined: Placebo of R10933 + R10987 Undetermined: Placebo of R10933 + R10987 Adult and Adolescent subjects (≥12 years) whose baseline RT-qPCR status was inconclusive or missing | 53 |
| Undetermined: R10933 + R10987 Undetermined: R10933 + R10987 Adult and Adolescent subjects (≥12 years) whose baseline RT-qPCR status was inconclusive or missing | 34 |
| Total | 3,298 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 2 | 3 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 38 | 28 | 0 | 3 | 3 | 2 | 1 |
| Overall Study | Physician Decision | 1 | 2 | 0 | 2 | 0 | 2 | 5 |
| Overall Study | Withdrawal by Subject | 46 | 40 | 0 | 18 | 6 | 8 | 6 |
Baseline characteristics
| Characteristic | Cohort A: Placebo of R10933 + R10987 | R10933 + R10987 | Cohort A1: Placebo of R10933 + R10987 | Cohort B: Placebo of R10933 + R10987 | Cohort B: R10933 + R10987 | Undetermined: Placebo of R10933 + R10987 | Undetermined: R10933 + R10987 | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 42.4 years STANDARD_DEVIATION 15.7 | 42.1 years STANDARD_DEVIATION 16 | 10.0 years STANDARD_DEVIATION 0 | 41.8 years STANDARD_DEVIATION 18.1 | 39.5 years STANDARD_DEVIATION 17.81 | 43.0 years STANDARD_DEVIATION 16.73 | 39.0 years STANDARD_DEVIATION 15.3 | 42.0 years STANDARD_DEVIATION 16.1 |
| Age, Customized 85 years and over | 6 Participants | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 11 Participants |
| Age, Customized Adolescents (12-17 years) | 47 Participants | 52 Participants | 0 Participants | 20 Participants | 23 Participants | 2 Participants | 1 Participants | 145 Participants |
| Age, Customized Adults (18-64 years) | 1272 Participants | 1263 Participants | 0 Participants | 130 Participants | 127 Participants | 45 Participants | 30 Participants | 2867 Participants |
| Age, Customized Children (2-11 years) | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Customized From 65-84 years | 105 Participants | 125 Participants | 0 Participants | 21 Participants | 15 Participants | 5 Participants | 3 Participants | 274 Participants |
| Age, Customized Infants and toddlers (28 days-23 months) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized In utero | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Newborns (0-27 days) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Preterm newborn infants (gestational age < 37 wks) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 707 Participants | 698 Participants | 1 Participants | 66 Participants | 69 Participants | 23 Participants | 9 Participants | 1573 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 711 Participants | 735 Participants | 0 Participants | 105 Participants | 96 Participants | 30 Participants | 25 Participants | 1702 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 12 Participants | 8 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 23 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 5 Participants | 4 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 11 Participants |
| Race/Ethnicity, Customized Asian | 37 Participants | 42 Participants | 0 Participants | 8 Participants | 11 Participants | 3 Participants | 2 Participants | 103 Participants |
| Race/Ethnicity, Customized Black or African American | 161 Participants | 164 Participants | 0 Participants | 11 Participants | 9 Participants | 4 Participants | 1 Participants | 350 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 2 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized Other | 32 Participants | 32 Participants | 0 Participants | 4 Participants | 5 Participants | 0 Participants | 2 Participants | 75 Participants |
| Race/Ethnicity, Customized White | 1193 Participants | 1196 Participants | 1 Participants | 149 Participants | 140 Participants | 46 Participants | 29 Participants | 2754 Participants |
| Sex: Female, Male Female | 738 Participants | 780 Participants | 0 Participants | 97 Participants | 80 Participants | 21 Participants | 20 Participants | 1736 Participants |
| Sex: Female, Male Male | 692 Participants | 661 Participants | 1 Participants | 76 Participants | 86 Participants | 32 Participants | 14 Participants | 1562 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 1,428 | 3 / 1,439 | 0 / 1 | 0 / 170 | 0 / 165 | 0 / 44 | 0 / 23 |
| other Total, other adverse events | 247 / 1,428 | 96 / 1,439 | 0 / 1 | 63 / 170 | 41 / 165 | 10 / 44 | 2 / 23 |
| serious Total, serious adverse events | 23 / 1,428 | 24 / 1,439 | 0 / 1 | 5 / 170 | 1 / 165 | 0 / 44 | 0 / 23 |
Outcome results
Primary
Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs
Time frame: Up to 8 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs | # of participants with at least one TEAE | 512 Participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs | # of participants with at least one Grade 1 TEAE | 384 Participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs | # of participants with at least one Grade 2 TEAE | 98 Participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs | # of participants with at least one Grade 3 TEAE | 26 Participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs | # of participants with at least one Grade 4 TEAE | 2 Participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs | # of participants with at least one Grade 5 TEAE | 2 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs | # of participants with at least one Grade 5 TEAE | 3 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs | # of participants with at least one Grade 3 TEAE | 21 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs | # of participants with at least one TEAE | 405 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs | # of participants with at least one Grade 2 TEAE | 95 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs | # of participants with at least one Grade 1 TEAE | 284 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs | # of participants with at least one Grade 4 TEAE | 2 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs | # of participants with at least one Grade 1 TEAE | 61 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs | # of participants with at least one Grade 2 TEAE | 21 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs | # of participants with at least one Grade 3 TEAE | 6 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs | # of participants with at least one Grade 5 TEAE | 0 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs | # of participants with at least one Grade 4 TEAE | 0 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs | # of participants with at least one TEAE | 88 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs | # of participants with at least one Grade 4 TEAE | 0 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs | # of participants with at least one Grade 5 TEAE | 0 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs | # of participants with at least one Grade 1 TEAE | 51 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs | # of participants with at least one Grade 3 TEAE | 2 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs | # of participants with at least one TEAE | 60 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs | # of participants with at least one Grade 2 TEAE | 7 Participants |
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.
Time frame: Up to 1 month
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) During the EAP | 7.8 Percentage of Participants |
| Cohort A: R10933 + R10987 | Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) During the EAP | 1.4 Percentage of Participants |
p-value: <0.000195% CI: [0.09, 0.332]Regression, Logistic
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).
Time frame: Up to 14 Days
Population: Estimate of percent of participants meeting the criteria based on fixed categories
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | 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 | 42.5 Percentage of Participants |
| Cohort A: R10933 + R10987 | 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 | 28.4 Percentage of Participants |
p-value: =0.03895% CI: [0.298, 0.966]Regression, Logistic
Secondary
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP
Time frame: Up to Day 29
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP | Total Symptomatic COVID-19 | 81 Participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP | Grade 1 Symptomatic COVID-19 | 68 Participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP | Grade 2 Symptomatic COVID-19 | 11 Participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP | Grade 3 Symptomatic COVID-19 | 2 Participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP | Grade 4 Symptomatic COVID-19 | 0 Participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP | Grade 5 Symptomatic COVID-19 | 0 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP | Grade 5 Symptomatic COVID-19 | 0 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP | Grade 3 Symptomatic COVID-19 | 0 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP | Total Symptomatic COVID-19 | 15 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP | Grade 2 Symptomatic COVID-19 | 4 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP | Grade 1 Symptomatic COVID-19 | 11 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP | Grade 4 Symptomatic COVID-19 | 0 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP | Grade 1 Symptomatic COVID-19 | 43 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP | Grade 2 Symptomatic COVID-19 | 12 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP | Grade 3 Symptomatic COVID-19 | 2 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP | Grade 5 Symptomatic COVID-19 | 0 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP | Grade 4 Symptomatic COVID-19 | 0 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP | Total Symptomatic COVID-19 | 57 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP | Grade 4 Symptomatic COVID-19 | 0 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP | Grade 5 Symptomatic COVID-19 | 0 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP | Grade 1 Symptomatic COVID-19 | 33 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP | Grade 3 Symptomatic COVID-19 | 0 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP | Total Symptomatic COVID-19 | 35 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the EAP | Grade 2 Symptomatic COVID-19 | 2 Participants |
Secondary
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period
Time frame: Day 30 Up to Day 225 (Approximately 8 months)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period | Total Symptomatic COVID-19 | 68 Participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period | Grade 1 Symptomatic COVID-19 | 50 Participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period | Grade 2 Symptomatic COVID-19 | 14 Participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period | Grade 3 Symptomatic COVID-19 | 4 Participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period | Grade 4 Symptomatic COVID-19 | 0 Participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period | Grade 5 Symptomatic COVID-19 | 0 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period | Grade 5 Symptomatic COVID-19 | 0 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period | Grade 3 Symptomatic COVID-19 | 0 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period | Total Symptomatic COVID-19 | 14 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period | Grade 2 Symptomatic COVID-19 | 2 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period | Grade 1 Symptomatic COVID-19 | 12 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period | Grade 4 Symptomatic COVID-19 | 0 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period | Grade 1 Symptomatic COVID-19 | 1 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period | Grade 2 Symptomatic COVID-19 | 0 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period | Grade 3 Symptomatic COVID-19 | 0 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period | Grade 5 Symptomatic COVID-19 | 0 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period | Grade 4 Symptomatic COVID-19 | 0 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period | Total Symptomatic COVID-19 | 1 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period | Grade 4 Symptomatic COVID-19 | 0 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period | Grade 5 Symptomatic COVID-19 | 0 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period | Grade 1 Symptomatic COVID-19 | 1 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period | Grade 3 Symptomatic COVID-19 | 0 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period | Total Symptomatic COVID-19 | 1 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections During the Follow-Up Period | Grade 2 Symptomatic COVID-19 | 0 Participants |
Secondary
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP
Time frame: Up to Day 29
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP | Total Symptomatic COVID-19 | 74 Participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP | Grade 1 Symptomatic COVID-19 | 64 Participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP | Grade 2 Symptomatic COVID-19 | 9 Participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP | Grade 3 Symptomatic COVID-19 | 1 Participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP | Grade 4 Symptomatic COVID-19 | 0 Participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP | Grade 5 Symptomatic COVID-19 | 0 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP | Grade 5 Symptomatic COVID-19 | 0 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP | Grade 3 Symptomatic COVID-19 | 0 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP | Total Symptomatic COVID-19 | 12 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP | Grade 2 Symptomatic COVID-19 | 3 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP | Grade 1 Symptomatic COVID-19 | 9 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP | Grade 4 Symptomatic COVID-19 | 0 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP | Grade 1 Symptomatic COVID-19 | 35 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP | Grade 2 Symptomatic COVID-19 | 10 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP | Grade 3 Symptomatic COVID-19 | 2 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP | Grade 5 Symptomatic COVID-19 | 0 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP | Grade 4 Symptomatic COVID-19 | 0 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP | Total Symptomatic COVID-19 | 47 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP | Grade 4 Symptomatic COVID-19 | 0 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP | Grade 5 Symptomatic COVID-19 | 0 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP | Grade 1 Symptomatic COVID-19 | 30 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP | Grade 3 Symptomatic COVID-19 | 0 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP | Total Symptomatic COVID-19 | 32 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the EAP | Grade 2 Symptomatic COVID-19 | 2 Participants |
Secondary
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period
Time frame: Day 30 Up to Day 225 (Approximately 8 months)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period | Total Symptomatic COVID-19 | 64 Participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period | Grade 1 Symptomatic COVID-19 | 47 Participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period | Grade 2 Symptomatic COVID-19 | 14 Participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period | Grade 3 Symptomatic COVID-19 | 3 Participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period | Grade 4 Symptomatic COVID-19 | 0 Participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period | Grade 5 Symptomatic COVID-19 | 0 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period | Grade 5 Symptomatic COVID-19 | 0 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period | Grade 3 Symptomatic COVID-19 | 0 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period | Total Symptomatic COVID-19 | 10 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period | Grade 2 Symptomatic COVID-19 | 2 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period | Grade 1 Symptomatic COVID-19 | 8 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period | Grade 4 Symptomatic COVID-19 | 0 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period | Grade 1 Symptomatic COVID-19 | 1 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period | Grade 2 Symptomatic COVID-19 | 0 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period | Grade 3 Symptomatic COVID-19 | 0 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period | Grade 5 Symptomatic COVID-19 | 0 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period | Grade 4 Symptomatic COVID-19 | 0 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period | Total Symptomatic COVID-19 | 1 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period | Grade 4 Symptomatic COVID-19 | 0 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period | Grade 5 Symptomatic COVID-19 | 0 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period | Grade 1 Symptomatic COVID-19 | 1 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period | Grade 3 Symptomatic COVID-19 | 0 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period | Total Symptomatic COVID-19 | 1 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seronegative Subjects During the Follow-Up Period | Grade 2 Symptomatic COVID-19 | 0 Participants |
Secondary
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP
Time frame: Up to Day 29
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP | Total Symptomatic COVID-19 | 6 Participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP | Grade 1 Symptomatic COVID-19 | 3 Participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP | Grade 2 Symptomatic COVID-19 | 2 Participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP | Grade 3 Symptomatic COVID-19 | 1 Participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP | Grade 4 Symptomatic COVID-19 | 0 Participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP | Grade 5 Symptomatic COVID-19 | 0 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP | Grade 5 Symptomatic COVID-19 | 0 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP | Grade 3 Symptomatic COVID-19 | 0 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP | Total Symptomatic COVID-19 | 3 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP | Grade 2 Symptomatic COVID-19 | 1 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP | Grade 1 Symptomatic COVID-19 | 2 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP | Grade 4 Symptomatic COVID-19 | 0 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP | Grade 1 Symptomatic COVID-19 | 5 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP | Grade 2 Symptomatic COVID-19 | 1 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP | Grade 3 Symptomatic COVID-19 | 0 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP | Grade 5 Symptomatic COVID-19 | 0 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP | Grade 4 Symptomatic COVID-19 | 0 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP | Total Symptomatic COVID-19 | 6 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP | Grade 4 Symptomatic COVID-19 | 0 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP | Grade 5 Symptomatic COVID-19 | 0 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP | Grade 1 Symptomatic COVID-19 | 3 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP | Grade 3 Symptomatic COVID-19 | 0 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP | Total Symptomatic COVID-19 | 3 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the EAP | Grade 2 Symptomatic COVID-19 | 0 Participants |
Secondary
Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period
Time frame: Day 30 Up to Day 225 (Approximately 8 months)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period | Total Symptomatic COVID-19 | 3 Participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period | Grade 1 Symptomatic COVID-19 | 3 Participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period | Grade 2 Symptomatic COVID-19 | 0 Participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period | Grade 3Symptomatic COVID-19 | 0 Participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period | Grade 4 Symptomatic COVID-19 | 0 Participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period | Grade 5 Symptomatic COVID-19 | 0 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period | Grade 5 Symptomatic COVID-19 | 0 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period | Grade 3Symptomatic COVID-19 | 0 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period | Total Symptomatic COVID-19 | 3 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period | Grade 2 Symptomatic COVID-19 | 0 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period | Grade 1 Symptomatic COVID-19 | 3 Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period | Grade 4 Symptomatic COVID-19 | 0 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period | Grade 1 Symptomatic COVID-19 | 0 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period | Grade 2 Symptomatic COVID-19 | 0 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period | Grade 3Symptomatic COVID-19 | 0 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period | Grade 5 Symptomatic COVID-19 | 0 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period | Grade 4 Symptomatic COVID-19 | 0 Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period | Total Symptomatic COVID-19 | 0 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period | Grade 4 Symptomatic COVID-19 | 0 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period | Grade 5 Symptomatic COVID-19 | 0 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period | Grade 1 Symptomatic COVID-19 | 0 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period | Grade 3Symptomatic COVID-19 | 0 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period | Total Symptomatic COVID-19 | 0 Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Incidence and Severity of Symptomatic SARS-CoV-2 Infections in Seropositive Subjects During the Follow-Up Period | Grade 2 Symptomatic COVID-19 | 0 Participants |
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)
Time frame: Up to 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Number of Weeks of High Viral Load in NP Swab Samples During the EAP | 0.18 weeks | Standard Deviation 0.554 |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Number of Weeks of High Viral Load in NP Swab Samples During the EAP | 0.02 weeks | Standard Deviation 0.154 |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Number of Weeks of High Viral Load in NP Swab Samples During the EAP | 0.81 weeks | Standard Deviation 0.758 |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Number of Weeks of High Viral Load in NP Swab Samples During the EAP | 0.49 weeks | Standard Deviation 0.677 |
p-value: <0.0001Stratified Wilcoxon Rank Sum Test
p-value: =0.001Stratified Wilcoxon Rank Sum Test
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)
Time frame: Up to 1 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | Cohort A and Cohort B: Percentage of Participants With High Viral Load in Nasopharyngeal (NP) Swab Samples During the EAP | 11.3 Percentage of Participants |
| Cohort A: R10933 + R10987 | Cohort A and Cohort B: Percentage of Participants With High Viral Load in Nasopharyngeal (NP) Swab Samples During the EAP | 1.6 Percentage of Participants |
| Cohort B: Placebo of R10933 + R10987 | Cohort A and Cohort B: Percentage of Participants With High Viral Load in Nasopharyngeal (NP) Swab Samples During the EAP | 62.6 Percentage of Participants |
| Cohort B: R10933 + R10987 | Cohort A and Cohort B: Percentage of Participants With High Viral Load in Nasopharyngeal (NP) Swab Samples During the EAP | 40.5 Percentage of Participants |
p-value: <0.000195% CI: [0.069, 0.236]Regression, Logistic
p-value: =0.002495% CI: [0.228, 0.728]Regression, Logistic
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
Time frame: Up to 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | 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 | 65.982 log10 copies/milliLiter * days | Standard Deviation 47.6933 |
| Cohort A: R10933 + R10987 | 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 | 19.700 log10 copies/milliLiter * days | Standard Deviation 14.8257 |
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
Time frame: Up to 1 month
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | 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 | 6.133 log10 copies/mL | Standard Error 0.301 |
| Cohort A: R10933 + R10987 | 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 | 3.705 log10 copies/mL | Standard Error 0.402 |
p-value: <0.000195% CI: [-3.196, -1.659]ANOVA
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)
Time frame: Up to 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | 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 | 0.98 days | Standard Deviation 4.659 |
| Cohort A: R10933 + R10987 | 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 | 0.15 days | Standard Deviation 1.276 |
p-value: <0.0001Stratified Wilcoxon Rank Sum Test
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
Time frame: Up to Day 29
Population: Only 1 participant in placebo group hospitalized
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | 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 | 11 Days |
Secondary
Cohort A: Number of Weeks of RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP
Time frame: Up to 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | Cohort A: Number of Weeks of RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP | 0.31 weeks | Standard Deviation 0.854 |
| Cohort A: R10933 + R10987 | Cohort A: Number of Weeks of RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP | 0.05 weeks | Standard Deviation 0.26 |
p-value: <0.0001Stratified Wilcoxon Rank Sum Test
Secondary
Cohort A: Number of Weeks of Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad Term) During the EAP
Time frame: Up to 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | Cohort A: Number of Weeks of Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad Term) During the EAP | 0.25 weeks | Standard Deviation 1.135 |
| Cohort A: R10933 + R10987 | Cohort A: Number of Weeks of Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad Term) During the EAP | 0.02 weeks | Standard Deviation 0.181 |
p-value: <0.0001Stratified Wilcoxon Rank Sum Test
Secondary
Cohort A: Number of Weeks of Symptomatic RT-qPCR-confirmed SARS-CoV-2 Infection (CDC Definition) During the EAP
Time frame: Up to 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | Cohort A: Number of Weeks of Symptomatic RT-qPCR-confirmed SARS-CoV-2 Infection (CDC Definition) During the EAP | 0.21 weeks | Standard Deviation 1.042 |
| Cohort A: R10933 + R10987 | Cohort A: Number of Weeks of Symptomatic RT-qPCR-confirmed SARS-CoV-2 Infection (CDC Definition) During the EAP | 0.01 weeks | Standard Deviation 0.128 |
p-value: <0.0001Stratified Wilcoxon Rank Sum Test
Secondary
Cohort A: Number of Weeks of Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Strict-term) During the EAP
Time frame: Up to 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | Cohort A: Number of Weeks of Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Strict-term) During the EAP | 0.12 weeks | Standard Deviation 0.843 |
| Cohort A: R10933 + R10987 | Cohort A: Number of Weeks of Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Strict-term) During the EAP | 0.00 weeks | Standard Deviation 0.084 |
p-value: <0.0001Stratified Wilcoxon Rank Sum Test
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)
Time frame: Up to 1 month
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | 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) | % with index case receiving R10933+R10987 in 2067 | 19.8 Percentage of Participants |
| Cohort A: Placebo of R10933 + R10987 | 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) | % with index case receiving placebo in 2067 | 19.6 Percentage of Participants |
| Cohort A: Placebo of R10933 + R10987 | 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) | % with index case treatment in 2067 not available | 10.5 Percentage of Participants |
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
Time frame: Up to 1 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | 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 | 1.1 Percentage of participants |
| Cohort A: R10933 + R10987 | 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 | 0.0 Percentage of participants |
Comparison: Testing if there is an association between the observed results and treatment received'p-value: =0.0038Fisher Exact
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)
Time frame: Up to 1 month
Population: Estimate of percentage of participants meeting the criteria based on fixed categories
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP | 14.56 Percentage of Participants |
| Cohort A: R10933 + R10987 | Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP | 5.00 Percentage of Participants |
p-value: <0.000195% CI: [0.208, 0.456]Multiple Imputation, Logistic Regression
Secondary
Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infections at Each Week in the EAP
Time frame: Week 1, Week 2, Week 3, Week 4
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infections at Each Week in the EAP | Week 1 | 8.9 Percentage of participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infections at Each Week in the EAP | Week 2 | 8.5 Percentage of participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infections at Each Week in the EAP | Week 3 | 7.7 Percentage of participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infections at Each Week in the EAP | Week 4 | 5.6 Percentage of participants |
| Cohort A: R10933 + R10987 | Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infections at Each Week in the EAP | Week 4 | 0.7 Percentage of participants |
| Cohort A: R10933 + R10987 | Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infections at Each Week in the EAP | Week 1 | 3.1 Percentage of participants |
| Cohort A: R10933 + R10987 | Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infections at Each Week in the EAP | Week 3 | 0.7 Percentage of participants |
| Cohort A: R10933 + R10987 | Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infections at Each Week in the EAP | Week 2 | 1.1 Percentage of participants |
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)
Time frame: Week 1, Week 2, Week 3, Week 4
Population: Estimate of percentage of participants meeting the criteria based on fixed categories
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) at Each Week in the EAP | Week 1 | 5.2 Percentage of participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) at Each Week in the EAP | Week 2 | 4.8 Percentage of participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) at Each Week in the EAP | Week 3 | 3.3 Percentage of participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) at Each Week in the EAP | Week 4 | 2.1 Percentage of participants |
| Cohort A: R10933 + R10987 | Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) at Each Week in the EAP | Week 4 | 0.1 Percentage of participants |
| Cohort A: R10933 + R10987 | Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) at Each Week in the EAP | Week 1 | 1.2 Percentage of participants |
| Cohort A: R10933 + R10987 | Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) at Each Week in the EAP | Week 3 | 0.0 Percentage of participants |
| Cohort A: R10933 + R10987 | Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) at Each Week in the EAP | Week 2 | 0.4 Percentage of participants |
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)
Time frame: Up to 1 month
Population: Estimate of percentage of participants meeting the criteria based on fixed categories
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Strict-term) During the EAP | 2.8 Percentage of participants |
| Cohort A: R10933 + R10987 | Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Strict-term) During the EAP | 0.2 Percentage of participants |
p-value: =0.00195% CI: [0.02, 0.37]Regression, Logistic
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.
Time frame: Up to 1 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | Cohort A: Percentage of Participants With a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (CDC Definition) During the EAP | 5.9 Percentage of participants |
| Cohort A: R10933 + R10987 | Cohort A: Percentage of Participants With a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (CDC Definition) During the EAP | 0.8 Percentage of participants |
p-value: <0.000195% CI: [0.051, 0.286]Regression, Logistic
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
Time frame: Up to 1 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | 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 | 0.5 Percentage of Participants |
| Cohort A: R10933 + R10987 | 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 | 0.0 Percentage of Participants |
Comparison: Testing if there is an association between the observed results and treatment receivedp-value: =0.0621Fisher Exact
Secondary
Cohort A: Proportion of Baseline Seropositive Participants (Based on Central Lab Test) With TEAEs and Severity of TEAEs
Time frame: Up to 8 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | Cohort A: Proportion of Baseline Seropositive Participants (Based on Central Lab Test) With TEAEs and Severity of TEAEs | with at least one TEAE | 79 Participants |
| Cohort A: Placebo of R10933 + R10987 | Cohort A: Proportion of Baseline Seropositive Participants (Based on Central Lab Test) With TEAEs and Severity of TEAEs | with at least one serious TEAE | 5 Participants |
| Cohort A: R10933 + R10987 | Cohort A: Proportion of Baseline Seropositive Participants (Based on Central Lab Test) With TEAEs and Severity of TEAEs | with at least one TEAE | 83 Participants |
| Cohort A: R10933 + R10987 | Cohort A: Proportion of Baseline Seropositive Participants (Based on Central Lab Test) With TEAEs and Severity of TEAEs | with at least one serious TEAE | 6 Participants |
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
Time frame: Up to 14 Days
Population: Estimate of proportion of participants meeting the criteria based on fixed categories
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | Cohort A: Proportion of Participants Hospitalized Related to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP | 0.001 Proportion of Participants |
| Cohort A: R10933 + R10987 | Cohort A: Proportion of Participants Hospitalized Related to a RT-qPCR Confirmed SARS-CoV-2 Infection That Has an Onset During the EAP | 0.0 Proportion of Participants |
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
Time frame: Up to 1 month
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | 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 | 6.141 log10 copies/mL | Standard Error 0.305 |
| Cohort A: R10933 + R10987 | 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 | 3.700 log10 copies/mL | Standard Error 0.396 |
p-value: <0.000195% CI: [-3.194, -1.688]ANOVA
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
Time frame: Up to 1 month
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | 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 | 3.689 log10 copies/mL | Standard Error 0.281 |
| Cohort A: R10933 + R10987 | 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 | 1.205 log10 copies/mL | Standard Error 0.368 |
p-value: <0.000195% CI: [-3.161, -1.806]ANOVA
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
Time frame: Up to 1 month
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | 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 | 3.065 log10 copies/mL | Standard Error 0.243 |
| Cohort A: R10933 + R10987 | 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 | 0.942 log10 copies/mL | Standard Error 0.317 |
p-value: <0.000195% CI: [-2.707, -1.539]ANOVA
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.
Time frame: Up to 1 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | 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 | 9 medically attended visits |
| Cohort A: R10933 + R10987 | 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 | 0 medically attended visits |
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
Time frame: Up to 14 Days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | 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 | 82.008 log10 copies/milliLiter*days | Standard Error 4.328 |
| Cohort A: R10933 + R10987 | 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 | 55.964 log10 copies/milliLiter*days | Standard Error 4.201 |
p-value: <0.000195% CI: [-37.973, -14.117]ANCOVA
Secondary
Cohort B: Change in Viral Load From Baseline to Day 15 Visit in NP Swab Samples
Time frame: Up to day 15 visit
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | Cohort B: Change in Viral Load From Baseline to Day 15 Visit in NP Swab Samples | -4.014 log10 copies/mL | Standard Error 0.195 |
| Cohort A: R10933 + R10987 | Cohort B: Change in Viral Load From Baseline to Day 15 Visit in NP Swab Samples | -4.864 log10 copies/mL | Standard Error 0.199 |
p-value: =0.002695% CI: [-1.4, -0.3]ANCOVA
Secondary
Cohort B: Change in Viral Load From Baseline to Day 8 Visit in NP Swab Samples
Time frame: Up to day 8 visit
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | Cohort B: Change in Viral Load From Baseline to Day 8 Visit in NP Swab Samples | -1.543 log10 copies/mL | Standard Error 0.238 |
| Cohort A: R10933 + R10987 | Cohort B: Change in Viral Load From Baseline to Day 8 Visit in NP Swab Samples | -3.004 log10 copies/mL | Standard Error 0.239 |
p-value: <0.000195% CI: [-2.127, -0.795]ANCOVA
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
Time frame: Up to 1 month
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | 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 | 4.731 log10 copies/mL | Standard Error 0.238 |
| Cohort A: R10933 + R10987 | 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 | 3.336 log10 copies/mL | Standard Error 0.24 |
p-value: <0.000195% CI: [-2.063, -0.727]ANCOVA
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
Time frame: Up to 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | 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 | 5.69 Days | Standard Deviation 8.802 |
| Cohort A: R10933 + R10987 | 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 | 5.18 Days | Standard Deviation 8.94 |
p-value: =0.7861Stratified Wilcoxon Rank Sum test
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
Time frame: Up to 1 month
Population: Estimate of proportion of participants meeting the criteria
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | 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 | 0.38 days | Standard Deviation 2.671 |
| Cohort A: R10933 + R10987 | 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 | 0.00 days | Standard Deviation 0 |
p-value: =0.0842Stratified Wilcoxon Rank Sum test
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
Time frame: Up to 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | 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 | 0.06 Medically attended visits | Standard Deviation 0.234 |
| Cohort A: R10933 + R10987 | 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 | 0.00 Medically attended visits | Standard Deviation 0 |
p-value: =0.0138Stratified Wilcoxon Rank Sum Test
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
Time frame: Up to 14 Days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | 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 | 1.64 weeks | Standard Deviation 3.493 |
| Cohort A: R10933 + R10987 | 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 | 0.90 weeks | Standard Deviation 2.586 |
p-value: =0.0273Stratified Wilcoxon Rank Sum Test
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
Time frame: Up to 14 Days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | 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 | 1.71 weeks | Standard Deviation 3.569 |
| Cohort A: R10933 + R10987 | 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 | 0.88 weeks | Standard Deviation 2.584 |
p-value: =0.026Stratified Wilcoxon Rank Sum Test
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
Time frame: Up to 14 Days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | 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 | 0.68 weeks | Standard Deviation 1.889 |
| Cohort A: R10933 + R10987 | 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 | 0.40 weeks | Standard Deviation 1.876 |
p-value: =0.0614Stratified Wilcoxon Rank Sum Test
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
Time frame: Up to 14 Days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | 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 | 2.9 Percentage of participants |
| Cohort A: R10933 + R10987 | 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 | 0.0 Percentage of participants |
Comparison: Testing if there is an association between the observed results and treatment receivedp-value: =0.2466Fisher Exact
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
Time frame: Up to 1 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | 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 | 5.8 Percentage of participants |
| Cohort A: R10933 + R10987 | 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 | 0.0 Percentage of participants |
Comparison: Testing if there is an association between the observed results and treatment receivedp-value: =0.0292Fisher Exact
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)
Time frame: Up to 14 Days
Population: Estimate of percentage of participants meeting the criteria based on fixed categories
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | 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 | 18.5 Percentage of Participants |
| Cohort A: R10933 + R10987 | 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 | 9.7 Percentage of Participants |
p-value: =0.072195% CI: [0.207, 1.07]Regression, Logistic
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)
Time frame: Up to 1 month
Population: Estimate of percentage of participants meeting the criteria based on fixed categories
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | 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 | 39.7 percentage of participants |
| Cohort A: R10933 + R10987 | 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 | 26.3 percentage of participants |
p-value: =0.04695% CI: [0.299, 0.989]Regression, Logistic
Secondary
Cohort B: Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) in NP Swab Samples Until the Day 22 Visit
Time frame: Day 22
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | Cohort B: Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) in NP Swab Samples Until the Day 22 Visit | -2.639 log10 copies/mL | Standard Error 0.136 |
| Cohort A: R10933 + R10987 | Cohort B: Time-weighted Average Change From Baseline in Viral Load (log10 Copies/mL) in NP Swab Samples Until the Day 22 Visit | -3.580 log10 copies/mL | Standard Error 0.137 |
p-value: <0.000195% CI: [-1.321, -0.559]ANCOVA
Secondary
Concentrations of REGN10933 in Serum Over Time (Cohort A)
Time frame: 0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | Concentrations of REGN10933 in Serum Over Time (Cohort A) | 0 Days Post-Dose (n=107) | 0.0190 milligrams per Liter (mg/L) | Standard Deviation 0.123 |
| Cohort A: Placebo of R10933 + R10987 | Concentrations of REGN10933 in Serum Over Time (Cohort A) | 28 Days Post-Dose (n=73) | 30.8 milligrams per Liter (mg/L) | Standard Deviation 12 |
| Cohort A: Placebo of R10933 + R10987 | Concentrations of REGN10933 in Serum Over Time (Cohort A) | 56 Days Post-Dose (n=106) | 14.8 milligrams per Liter (mg/L) | Standard Deviation 7.18 |
| Cohort A: Placebo of R10933 + R10987 | Concentrations of REGN10933 in Serum Over Time (Cohort A) | 112 Days Post-Dose (n=88) | 3.61 milligrams per Liter (mg/L) | Standard Deviation 2.46 |
Secondary
Concentrations of REGN10933 in Serum Over Time (Cohort B)
Time frame: 0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | Concentrations of REGN10933 in Serum Over Time (Cohort B) | 0 Days Post-Dose (n=7) | 0 milligrams per Liter (mg/L) | Standard Deviation 0 |
| Cohort A: Placebo of R10933 + R10987 | Concentrations of REGN10933 in Serum Over Time (Cohort B) | 28 Days Post-Dose (n=6) | 37.6 milligrams per Liter (mg/L) | Standard Deviation 13.3 |
| Cohort A: Placebo of R10933 + R10987 | Concentrations of REGN10933 in Serum Over Time (Cohort B) | 56 Days Post-Dose (n=8) | 19.1 milligrams per Liter (mg/L) | Standard Deviation 9.5 |
| Cohort A: Placebo of R10933 + R10987 | Concentrations of REGN10933 in Serum Over Time (Cohort B) | 112 Days Post-Dose (n=3) | 4.58 milligrams per Liter (mg/L) | Standard Deviation 3.02 |
Secondary
Concentrations of REGN10987 in Serum Over Time (Cohort A)
Time frame: 0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | Concentrations of REGN10987 in Serum Over Time (Cohort A) | 56 Days Post-Dose (n=105) | 10.4 milligrams per Liter (mg/L) | Standard Deviation 5.88 |
| Cohort A: Placebo of R10933 + R10987 | Concentrations of REGN10987 in Serum Over Time (Cohort A) | 0 Days Post-Dose (n=107) | 0.0233 milligrams per Liter (mg/L) | Standard Deviation 0.145 |
| Cohort A: Placebo of R10933 + R10987 | Concentrations of REGN10987 in Serum Over Time (Cohort A) | 28 Days Post-Dose (n=74) | 24.6 milligrams per Liter (mg/L) | Standard Deviation 9.78 |
| Cohort A: Placebo of R10933 + R10987 | Concentrations of REGN10987 in Serum Over Time (Cohort A) | 112 Days Post-Dose (n=88) | 2.10 milligrams per Liter (mg/L) | Standard Deviation 1.68 |
Secondary
Concentrations of REGN10987 in Serum Over Time (Cohort B)
Time frame: 0 Days Post-Dose, 28 Days Post-Dose, 56 Days Post-Dose, 112 Days Post-Dose
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | Concentrations of REGN10987 in Serum Over Time (Cohort B) | 0 Days Post-Dose (n=7) | 0 milligrams per Liter (mg/L) | Standard Deviation 0 |
| Cohort A: Placebo of R10933 + R10987 | Concentrations of REGN10987 in Serum Over Time (Cohort B) | 28 Days Post-Dose (n=6) | 31.0 milligrams per Liter (mg/L) | Standard Deviation 8.26 |
| Cohort A: Placebo of R10933 + R10987 | Concentrations of REGN10987 in Serum Over Time (Cohort B) | 56 Days Post-Dose (n=8) | 14.0 milligrams per Liter (mg/L) | Standard Deviation 6.2 |
| Cohort A: Placebo of R10933 + R10987 | Concentrations of REGN10987 in Serum Over Time (Cohort B) | 112 Days Post-Dose (n=5) | 4.62 milligrams per Liter (mg/L) | Standard Deviation 3.3 |
Secondary
Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933
Time frame: Up to 8 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 | 1544 Participants |
| Cohort A: R10933 + R10987 | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 | 1319 Participants |
Secondary
Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987
Time frame: Up to 8 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 | 1500 Participants |
| Cohort A: R10933 + R10987 | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 | 1251 Participants |
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
Time frame: Up to 8 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933 | 4 Participants |
| Cohort A: R10933 + R10987 | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933 | 33 Participants |
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
Time frame: Up to 8 Months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort A: Placebo of R10933 + R10987 | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 | 27 Participants |
| Cohort A: R10933 + R10987 | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 | 160 Participants |