COVID-19
Conditions
Keywords
Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) coronavirus, Non-hospitalized
Brief summary
The primary objective of the study is to assess the virologic efficacy of REGN10933+REGN10987 across different intravenous and subcutaneous doses compared to placebo. The secondary objectives of the study are: * To evaluate additional indicators of virologic efficacy of REGN10933+REGN10987 compared to placebo * To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo * To assess the concentrations of REGN10933 and REGN10987 in serum over time * To assess the immunogenicity of REGN10933 and REGN10987
Interventions
Administered IV or SC single dose
DRUGPlacebo
Administered IV or SC single dose to match
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
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Has SARS-CoV-2-positive diagnostic test from a sample collected ≤72 hours prior to randomization, as defined by the protocol * Low-risk symptomatic patient: Has symptoms consistent with COVID-19 (as determined by the investigator) with onset ≤7 days before randomization, and meets all of the following 8 criteria: 1. Age ≤50 2. No obesity, with obesity defined as BMI ≥30 kg/m2 3. Does not have cardiovascular disease or hypertension 4. Does not have chronic lung disease or asthma 5. Does not have type 1 or type 2 diabetes mellitus 6. Does not have chronic kidney disease, with or without dialysis 7. Does not have chronic liver disease 8. Is not pregnant or * Asymptomatic patient: Has had no symptoms consistent with COVID-19 (as determined by the investigator) occurring at any time \<2 months prior to randomization * Maintains O2 saturation ≥93% on room air Key
Exclusion criteria
* Was admitted to a hospital for COVID-19 prior to randomization, or is hospitalized (inpatient) for any reason at randomization * Has a known positive SARS-CoV-2 serologic test * Has a positive SARS-CoV-2 antigen or molecular diagnostic test from a sample collected \>72 hours prior to randomization * Is immunosuppressed, based on investigator's assessment * Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, mAbs against SARS-CoV-2, or intravenous immunoglobulin (IVIG) within 3 months or within 5 half-lives of the investigational product (whichever is longer) prior to the screening visit * Prior, current, or planned future use of any of the following treatments: COVID-19 convalescent plasma, mAbs against SARS-CoV-2, (eg, bamlanivimab), IVIG (any indication), systemic corticosteroids (any indication), or COVID-19 treatments (authorized, approved, or investigational) * Prior use (prior to randomization), current use (at randomization), or planned use (within time period given per CDC guidance but no sooner than 22 days of study drug administration) of any authorized or approved vaccine for COVID-19 * Has known active infection with influenza or other non-SARS-CoV-2 respiratory pathogen, confirmed by a diagnostic test * Has participated, is participating, or plans to participate in a clinical research study evaluating any authorized, approved, or investigational vaccine for COVID-19 NOTE: Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time-Weighted Average Daily Change From Day 1 in Viral Load in NP Swab Samples | Day 1 to Day 7 | Time-weighted average daily change from Day 1 in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Day 1 to Day 7 | Time-weighted average daily change from Day 1 in viral load (log10 copies/mL) as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples. in any participant with a viral load greater than 10,000 copies/mL at baseline. |
| Number of Participants With High Viral Load | Day 1, Day 3, Day 5, Day 7, Day 15, Day 22 | Number of participants with viral load greater than 10,000 copies/mL, as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples. |
| Number of Participants With Viral Loads Below the Limit of Detection | Day 1, Day 3, Day 5, Day 7, Day 15, Day 22 | Number of participants with viral load less than 299 copies/mL, as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples. |
| Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 1, Day 3, Day 5, Day 7, Day 15, Day 22 | Number of participants with viral load less than 714 copies/mL, as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples. |
| Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples | Day 3, Day 5, Day 7, Day 15, Day 22 | Change from Day 1 in Viral Load (log10 copies/mL) as Measured by Quantitative reverse transcription polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) Swab Samples |
| Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs) | Through day 29 | — |
| Number of Participants With Infusion-Related Reactions Grade 2 or Above | Through day 4 | — |
| Time-Weighted Average Daily Change From Day 1 in Viral Load | Day 1 to Day 5 | Time-weighted average daily change from Day 1 in viral load (log10 copies/mL) as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples. |
| Number of Participants With Hypersensitivity Reactions Grade 2 or Above | Through day 29 | — |
| Concentration of REGN10933 in Serum | Pre-Dose, 15 minutes Post-Dose, 3 days Post-Dose, 5 days Post-Dose, 7 days Post-Dose, 120 days Post-Dose | — |
| Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 | Through day 120 | — |
| Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933 | Through day 120 | — |
| Concentration of REGN10987 in Serum | Pre-Dose, 15 minutes Post-Dose, 3 days Post-Dose, 5 days Post-Dose, 7 days Post-Dose, 120 days Post-Dose | — |
| Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 | Through day 120 | — |
| Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 | Through day 120 | — |
| Number of Participants With Injection-Site Reactions Grade 3 or Above | Through day 4 | — |
Countries
United States
Participant flow
Pre-assignment details
A total of 1186 participants were screened and 1149 participants randomized and treated. Reasons for discontinuation at screening phase: 26-Screen Failure, 8-Subject Decision, 1-Sponsor Request, 1-Other. 1 randomized participant was not treated due to lack of supplies.
Participants by arm
| Arm | Count |
|---|---|
| Placebo IV Dose Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 | 82 |
| 300mg IV Participants received a single 300mg intravenous dose of REGN10933+REGN10987 | 165 |
| 600mg IV Participants received a single 600mg intravenous dose of REGN10933+REGN10987 | 162 |
| 1200mg IV Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 | 165 |
| 2400mg IV Participants received a single 2400mg intravenous dose of REGN10933+REGN10987 | 166 |
| Placebo SC Dose Participants received a single subcutaneous dose of placebo matching REGN10933+REGN10987 | 82 |
| 600mg SC Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987 | 163 |
| 1200mg SC Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987 | 164 |
| Total | 1,149 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 4 | 1 | 3 | 0 | 2 | 2 | 2 |
| Overall Study | Subject Decision | 1 | 1 | 3 | 1 | 0 | 1 | 3 | 2 |
Baseline characteristics
| Characteristic | Placebo IV Dose | Total | 1200mg SC | 600mg SC | Placebo SC Dose | 2400mg IV | 1200mg IV | 600mg IV | 300mg IV |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 33.5 years STANDARD_DEVIATION 10.15 | 34.0 years STANDARD_DEVIATION 9.7 | 33.0 years STANDARD_DEVIATION 10.18 | 33.5 years STANDARD_DEVIATION 9.5 | 36.3 years STANDARD_DEVIATION 9.88 | 33.9 years STANDARD_DEVIATION 9.24 | 34.4 years STANDARD_DEVIATION 9.81 | 34.2 years STANDARD_DEVIATION 10.08 | 33.9 years STANDARD_DEVIATION 8.99 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 26 Participants | 446 Participants | 62 Participants | 68 Participants | 32 Participants | 73 Participants | 60 Participants | 58 Participants | 67 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 55 Participants | 684 Participants | 99 Participants | 94 Participants | 49 Participants | 91 Participants | 102 Participants | 98 Participants | 96 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 19 Participants | 3 Participants | 1 Participants | 1 Participants | 2 Participants | 3 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 5 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 11 Participants | 67 Participants | 12 Participants | 12 Participants | 4 Participants | 3 Participants | 12 Participants | 7 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 72 Participants | 11 Participants | 7 Participants | 2 Participants | 17 Participants | 13 Participants | 8 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 36 Participants | 5 Participants | 2 Participants | 4 Participants | 5 Participants | 7 Participants | 6 Participants | 5 Participants |
| Race (NIH/OMB) White | 66 Participants | 966 Participants | 136 Participants | 141 Participants | 72 Participants | 141 Participants | 131 Participants | 138 Participants | 141 Participants |
| Sex: Female, Male Female | 51 Participants | 600 Participants | 85 Participants | 82 Participants | 39 Participants | 91 Participants | 92 Participants | 73 Participants | 87 Participants |
| Sex: Female, Male Male | 31 Participants | 549 Participants | 79 Participants | 81 Participants | 43 Participants | 75 Participants | 73 Participants | 89 Participants | 78 Participants |
| Viral Load in Nasopharyngeal Swab Samples | 5.98 log10 copies/mL STANDARD_DEVIATION 2.753 | 6.01 log10 copies/mL STANDARD_DEVIATION 2.719 | 5.90 log10 copies/mL STANDARD_DEVIATION 2.832 | 6.15 log10 copies/mL STANDARD_DEVIATION 2.481 | 6.28 log10 copies/mL STANDARD_DEVIATION 2.521 | 6.12 log10 copies/mL STANDARD_DEVIATION 2.521 | 5.87 log10 copies/mL STANDARD_DEVIATION 2.656 | 5.70 log10 copies/mL STANDARD_DEVIATION 3.171 | 6.20 log10 copies/mL STANDARD_DEVIATION 2.697 |
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 | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 82 | 0 / 165 | 0 / 162 | 0 / 165 | 0 / 166 | 0 / 82 | 0 / 163 | 0 / 164 |
| other Total, other adverse events | 17 / 82 | 21 / 165 | 27 / 162 | 28 / 165 | 16 / 166 | 11 / 82 | 18 / 163 | 21 / 164 |
| serious Total, serious adverse events | 1 / 82 | 1 / 165 | 0 / 162 | 1 / 165 | 3 / 166 | 0 / 82 | 0 / 163 | 1 / 164 |
Outcome results
Primary
Time-Weighted Average Daily Change From Day 1 in Viral Load in NP Swab Samples
Time-weighted average daily change from Day 1 in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.
Time frame: Day 1 to Day 7
Population: Seronegative modified Full Analysis Set (Seronegative mFAS): Participants in the Full Analysis Set (Overall mFAS) who were seronegative at baseline
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pooled Placebo (IV + SC) | Time-Weighted Average Daily Change From Day 1 in Viral Load in NP Swab Samples | -1.68 log10 copies/mL | Standard Error 0.11 |
| 300mg IV | Time-Weighted Average Daily Change From Day 1 in Viral Load in NP Swab Samples | -2.25 log10 copies/mL | Standard Error 0.11 |
| 600mg IV | Time-Weighted Average Daily Change From Day 1 in Viral Load in NP Swab Samples | -2.34 log10 copies/mL | Standard Error 0.12 |
| 1200mg IV | Time-Weighted Average Daily Change From Day 1 in Viral Load in NP Swab Samples | -2.24 log10 copies/mL | Standard Error 0.12 |
| 2400mg IV | Time-Weighted Average Daily Change From Day 1 in Viral Load in NP Swab Samples | -2.40 log10 copies/mL | Standard Error 0.12 |
| 600mg SC | Time-Weighted Average Daily Change From Day 1 in Viral Load in NP Swab Samples | -2.24 log10 copies/mL | Standard Error 0.12 |
| 1200mg SC | Time-Weighted Average Daily Change From Day 1 in Viral Load in NP Swab Samples | -2.24 log10 copies/mL | Standard Error 0.12 |
Comparison: Difference vs. Placebo (log10 copies/mL)p-value: 0.000495% CI: [-0.88, -0.25]ANCOVA
Comparison: Difference vs. Placebo (log10 copies/mL)p-value: <0.000195% CI: [-0.99, -0.34]ANCOVA
Comparison: Difference vs. Placebo (log10 copies/mL)p-value: 0.000795% CI: [-0.89, -0.24]ANCOVA
Comparison: Difference vs. Placebo (log10 copies/mL)p-value: <0.000195% CI: [-1.05, -0.38]ANCOVA
Comparison: Difference vs. Placebo (log10 copies/mL)p-value: 0.000695% CI: [-0.88, -0.24]ANCOVA
Comparison: Difference vs. Placebo (log10 copies/mL)p-value: 0.000795% CI: [-0.87, -0.24]ANCOVA
Secondary
Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples
Change from Day 1 in Viral Load (log10 copies/mL) as Measured by Quantitative reverse transcription polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) Swab Samples
Time frame: Day 3, Day 5, Day 7, Day 15, Day 22
Population: Seronegative modified Full Analysis Set (Seronegative mFAS): Participants in the Full Analysis Set (Overall mFAS) who were seronegative at baseline
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo (IV + SC) | Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples | Day 7 change from Day 1 | -3.44 log10 copies/mL | Standard Error 0.16 |
| Pooled Placebo (IV + SC) | Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples | Day 3 change from Day 1 | -1.22 log10 copies/mL | Standard Error 0.13 |
| Pooled Placebo (IV + SC) | Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples | Day 22 change from Day 1 | -6.27 log10 copies/mL | Standard Error 0.13 |
| Pooled Placebo (IV + SC) | Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples | Day 5 change from Day 1 | -2.29 log10 copies/mL | Standard Error 0.16 |
| Pooled Placebo (IV + SC) | Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples | Day 15 change from Day 1 | -5.66 log10 copies/mL | Standard Error 0.16 |
| 300mg IV | Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples | Day 7 change from Day 1 | -4.24 log10 copies/mL | Standard Error 0.16 |
| 300mg IV | Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples | Day 5 change from Day 1 | -3.24 log10 copies/mL | Standard Error 0.16 |
| 300mg IV | Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples | Day 15 change from Day 1 | -6.11 log10 copies/mL | Standard Error 0.16 |
| 300mg IV | Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples | Day 3 change from Day 1 | -1.71 log10 copies/mL | Standard Error 0.13 |
| 300mg IV | Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples | Day 22 change from Day 1 | -6.58 log10 copies/mL | Standard Error 0.14 |
| 600mg IV | Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples | Day 22 change from Day 1 | -6.50 log10 copies/mL | Standard Error 0.14 |
| 600mg IV | Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples | Day 5 change from Day 1 | -3.37 log10 copies/mL | Standard Error 0.16 |
| 600mg IV | Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples | Day 3 change from Day 1 | -1.91 log10 copies/mL | Standard Error 0.14 |
| 600mg IV | Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples | Day 7 change from Day 1 | -4.08 log10 copies/mL | Standard Error 0.16 |
| 600mg IV | Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples | Day 15 change from Day 1 | -5.97 log10 copies/mL | Standard Error 0.17 |
| 1200mg IV | Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples | Day 7 change from Day 1 | -4.10 log10 copies/mL | Standard Error 0.17 |
| 1200mg IV | Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples | Day 3 change from Day 1 | -1.85 log10 copies/mL | Standard Error 0.14 |
| 1200mg IV | Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples | Day 5 change from Day 1 | -3.32 log10 copies/mL | Standard Error 0.17 |
| 1200mg IV | Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples | Day 15 change from Day 1 | -5.91 log10 copies/mL | Standard Error 0.17 |
| 1200mg IV | Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples | Day 22 change from Day 1 | -6.56 log10 copies/mL | Standard Error 0.14 |
| 2400mg IV | Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples | Day 3 change from Day 1 | -1.69 log10 copies/mL | Standard Error 0.14 |
| 2400mg IV | Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples | Day 22 change from Day 1 | -6.36 log10 copies/mL | Standard Error 0.15 |
| 2400mg IV | Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples | Day 7 change from Day 1 | -4.17 log10 copies/mL | Standard Error 0.17 |
| 2400mg IV | Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples | Day 15 change from Day 1 | -5.77 log10 copies/mL | Standard Error 0.17 |
| 2400mg IV | Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples | Day 5 change from Day 1 | -3.33 log10 copies/mL | Standard Error 0.17 |
| 600mg SC | Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples | Day 3 change from Day 1 | -1.55 log10 copies/mL | Standard Error 0.13 |
| 600mg SC | Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples | Day 22 change from Day 1 | -6.69 log10 copies/mL | Standard Error 0.14 |
| 600mg SC | Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples | Day 15 change from Day 1 | -6.17 log10 copies/mL | Standard Error 0.17 |
| 600mg SC | Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples | Day 5 change from Day 1 | -3.19 log10 copies/mL | Standard Error 0.16 |
| 600mg SC | Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples | Day 7 change from Day 1 | -4.33 log10 copies/mL | Standard Error 0.16 |
| 1200mg SC | Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples | Day 15 change from Day 1 | -6.05 log10 copies/mL | Standard Error 0.16 |
| 1200mg SC | Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples | Day 5 change from Day 1 | -3.20 log10 copies/mL | Standard Error 0.16 |
| 1200mg SC | Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples | Day 7 change from Day 1 | -4.04 log10 copies/mL | Standard Error 0.16 |
| 1200mg SC | Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples | Day 3 change from Day 1 | -1.65 log10 copies/mL | Standard Error 0.13 |
| 1200mg SC | Change From Day 1 in Viral Load as Measured by RT-qPCR in NP Swab Samples | Day 22 change from Day 1 | -6.60 log10 copies/mL | Standard Error 0.13 |
Comparison: Difference vs. Placebo, by Day 3 (log10 copies/mL)p-value: 0.00795% CI: [-0.85, -0.14]Mixed Model for Repeated Measures (MMRM)
Comparison: Difference vs. Placebo, by Day 3 (log10 copies/mL)p-value: 0.000295% CI: [-1.06, -0.33]Mixed Model for Repeated Measures (MMRM)
Comparison: Difference vs. Placebo, by Day 3 (log10 copies/mL)p-value: 0.000895% CI: [-1, -0.26]Mixed Model for Repeated Measures (MMRM)
Comparison: Difference vs. Placebo, by Day 3 (log10 copies/mL)p-value: 0.012595% CI: [-0.85, -0.1]Mixed Model for Repeated Measures (MMRM)
Comparison: Difference vs. Placebo, by Day 3 (log10 copies/mL)p-value: 0.069695% CI: [-0.7, 0.03]Mixed Model for Repeated Measures (MMRM)
Comparison: Difference vs. Placebo, by Day 3 (log10 copies/mL)p-value: 0.018795% CI: [-0.79, -0.07]Mixed Model for Repeated Measures (MMRM)
Comparison: Difference vs. Placebo, by Day 5 (log10 copies/mL)p-value: <0.000195% CI: [-1.39, -0.52]Mixed Model for Repeated Measures (MMRM)
Comparison: Difference vs. Placebo, by Day 5 (log10 copies/mL)p-value: <0.000195% CI: [-1.53, -0.64]Mixed Model for Repeated Measures (MMRM)
Comparison: Difference vs. Placebo, by Day 5 (log10 copies/mL)p-value: <0.000195% CI: [-1.48, -0.59]Mixed Model for Repeated Measures (MMRM)
Comparison: Difference vs. Placebo, by Day 5 (log10 copies/mL)p-value: <0.000195% CI: [-1.5, -0.6]Mixed Model for Repeated Measures (MMRM)
Comparison: Difference vs. Placebo, by Day 5 (log10 copies/mL)p-value: <0.000195% CI: [-1.34, -0.46]Mixed Model for Repeated Measures (MMRM)
Comparison: Difference vs. Placebo, by Day 5 (log10 copies/mL)p-value: <0.000195% CI: [-1.35, -0.48]Mixed Model for Repeated Measures (MMRM)
Comparison: Difference vs. Placebo, by Day 7 (log10 copies/mL)p-value: 0.000495% CI: [-1.23, -0.35]Mixed Model for Repeated Measures (MMRM)
Comparison: Difference vs. Placebo, by Day 7 (log10 copies/mL)p-value: 0.005895% CI: [-1.08, -0.18]Mixed Model for Repeated Measures (MMRM)
Comparison: Difference vs. Placebo, by Day 7 (log10 copies/mL)p-value: 0.004695% CI: [-1.11, -0.2]Mixed Model for Repeated Measures (MMRM)
Comparison: Difference vs. Placebo, by Day 7 (log10 copies/mL)p-value: 0.001995% CI: [-1.18, -0.27]Mixed Model for Repeated Measures (MMRM)
Comparison: Difference vs. Placebo, by Day 7 (log10 copies/mL)p-value: <0.000195% CI: [-1.33, -0.44]Mixed Model for Repeated Measures (MMRM)
Comparison: Difference vs. Placebo, by Day 7 (log10 copies/mL)p-value: 0.007995% CI: [-1.04, -0.16]Mixed Model for Repeated Measures (MMRM)
Comparison: Difference vs. Placebo, by Day 15 (log10 copies/mL)p-value: 0.051595% CI: [-0.9, 0]Mixed Model for Repeated Measures (MMRM)
Comparison: Difference vs. Placebo, by Day 15 (log10 copies/mL)p-value: 0.186495% CI: [-0.77, 0.15]Mixed Model for Repeated Measures (MMRM)
Comparison: Difference vs. Placebo, by Day 15 (log10 copies/mL)p-value: 0.286695% CI: [-0.72, 0.21]Mixed Model for Repeated Measures (MMRM)
Comparison: Difference vs. Placebo, by Day 15 (log10 copies/mL)p-value: 0.64795% CI: [-0.58, 0.36]Mixed Model for Repeated Measures (MMRM)
Comparison: Difference vs. Placebo, by Day 15 (log10 copies/mL)p-value: 0.02895% CI: [-0.97, -0.06]Mixed Model for Repeated Measures (MMRM)
Comparison: Difference vs. Placebo, by Day 15 (log10 copies/mL)p-value: 0.085495% CI: [-0.84, 0.05]Mixed Models Analysis
Comparison: Difference vs. Placebo, by Day 22 (log10 copies/mL)p-value: 0.107895% CI: [-0.69, 0.07]Mixed Model for Repeated Measures (MMRM)
Comparison: Difference vs. Placebo, by Day 22 (log10 copies/mL)p-value: 0.223595% CI: [-0.62, 0.14]Mixed Model for Repeated Measures (MMRM)
Comparison: Difference vs. Placebo, by Day 22 (log10 copies/mL)p-value: 0.136995% CI: [-0.68, 0.09]Mixed Model for Repeated Measures (MMRM)
Comparison: Difference vs. Placebo, by Day 22 (log10 copies/mL)p-value: 0.66195% CI: [-0.48, 0.31]Mixed Model for Repeated Measures (MMRM)
Comparison: Difference vs. Placebo, by Day 22 (log10 copies/mL)p-value: 0.028495% CI: [-0.81, -0.05]Mixed Model for Repeated Measures (MMRM)
Comparison: Difference vs. Placebo, by Day 22 (log10 copies/mL)p-value: 0.0895% CI: [-0.71, 0.04]Mixed Model for Repeated Measures (MMRM)
Secondary
Concentration of REGN10933 in Serum
Time frame: Pre-Dose, 15 minutes Post-Dose, 3 days Post-Dose, 5 days Post-Dose, 7 days Post-Dose, 120 days Post-Dose
Population: Number Analyzed = number of participants contributing to each nominal timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo (IV + SC) | Concentration of REGN10933 in Serum | Pre-dose | 0.529 milligrams per liter (mg/L) | Standard Deviation 4.51 |
| Pooled Placebo (IV + SC) | Concentration of REGN10933 in Serum | 15 minutes Post-Dose | 58.2 milligrams per liter (mg/L) | Standard Deviation 52.1 |
| Pooled Placebo (IV + SC) | Concentration of REGN10933 in Serum | 3 days Post-Dose | 32.5 milligrams per liter (mg/L) | Standard Deviation 15.7 |
| Pooled Placebo (IV + SC) | Concentration of REGN10933 in Serum | 5 days Post-Dose | 27.7 milligrams per liter (mg/L) | Standard Deviation 16.8 |
| Pooled Placebo (IV + SC) | Concentration of REGN10933 in Serum | 7 days Post-Dose | 23.9 milligrams per liter (mg/L) | Standard Deviation 13.5 |
| Pooled Placebo (IV + SC) | Concentration of REGN10933 in Serum | 120 days Post-Dose | 1.78 milligrams per liter (mg/L) | Standard Deviation 1.13 |
| 300mg IV | Concentration of REGN10933 in Serum | 15 minutes Post-Dose | 95.8 milligrams per liter (mg/L) | Standard Deviation 57.9 |
| 300mg IV | Concentration of REGN10933 in Serum | 5 days Post-Dose | 46.6 milligrams per liter (mg/L) | Standard Deviation 16.9 |
| 300mg IV | Concentration of REGN10933 in Serum | 120 days Post-Dose | 3.25 milligrams per liter (mg/L) | Standard Deviation 1.88 |
| 300mg IV | Concentration of REGN10933 in Serum | Pre-dose | 1.95 milligrams per liter (mg/L) | Standard Deviation 12.1 |
| 300mg IV | Concentration of REGN10933 in Serum | 3 days Post-Dose | 54.9 milligrams per liter (mg/L) | Standard Deviation 19.2 |
| 300mg IV | Concentration of REGN10933 in Serum | 7 days Post-Dose | 39.8 milligrams per liter (mg/L) | Standard Deviation 11.5 |
| 600mg IV | Concentration of REGN10933 in Serum | 120 days Post-Dose | 6.46 milligrams per liter (mg/L) | Standard Deviation 4.74 |
| 600mg IV | Concentration of REGN10933 in Serum | 7 days Post-Dose | 82.8 milligrams per liter (mg/L) | Standard Deviation 26.3 |
| 600mg IV | Concentration of REGN10933 in Serum | 5 days Post-Dose | 88.4 milligrams per liter (mg/L) | Standard Deviation 27.8 |
| 600mg IV | Concentration of REGN10933 in Serum | 3 days Post-Dose | 109 milligrams per liter (mg/L) | Standard Deviation 37.9 |
| 600mg IV | Concentration of REGN10933 in Serum | Pre-dose | 0.847 milligrams per liter (mg/L) | Standard Deviation 6.28 |
| 600mg IV | Concentration of REGN10933 in Serum | 15 minutes Post-Dose | 178 milligrams per liter (mg/L) | Standard Deviation 118 |
| 1200mg IV | Concentration of REGN10933 in Serum | 5 days Post-Dose | 186 milligrams per liter (mg/L) | Standard Deviation 53.3 |
| 1200mg IV | Concentration of REGN10933 in Serum | 15 minutes Post-Dose | 375 milligrams per liter (mg/L) | Standard Deviation 267 |
| 1200mg IV | Concentration of REGN10933 in Serum | 3 days Post-Dose | 223 milligrams per liter (mg/L) | Standard Deviation 63.9 |
| 1200mg IV | Concentration of REGN10933 in Serum | 120 days Post-Dose | 12.3 milligrams per liter (mg/L) | Standard Deviation 8.42 |
| 1200mg IV | Concentration of REGN10933 in Serum | 7 days Post-Dose | 164 milligrams per liter (mg/L) | Standard Deviation 46 |
| 1200mg IV | Concentration of REGN10933 in Serum | Pre-dose | 13.3 milligrams per liter (mg/L) | Standard Deviation 130 |
| 2400mg IV | Concentration of REGN10933 in Serum | Pre-dose | 0.992 milligrams per liter (mg/L) | Standard Deviation 12.5 |
| 2400mg IV | Concentration of REGN10933 in Serum | 7 days Post-Dose | 26.8 milligrams per liter (mg/L) | Standard Deviation 9.65 |
| 2400mg IV | Concentration of REGN10933 in Serum | 15 minutes Post-Dose | 8.73 milligrams per liter (mg/L) | Standard Deviation 52.7 |
| 2400mg IV | Concentration of REGN10933 in Serum | 3 days Post-Dose | 22.4 milligrams per liter (mg/L) | Standard Deviation 18.3 |
| 2400mg IV | Concentration of REGN10933 in Serum | 5 days Post-Dose | 26.3 milligrams per liter (mg/L) | Standard Deviation 10.7 |
| 2400mg IV | Concentration of REGN10933 in Serum | 120 days Post-Dose | 2.73 milligrams per liter (mg/L) | Standard Deviation 1.89 |
| 600mg SC | Concentration of REGN10933 in Serum | 5 days Post-Dose | 54.9 milligrams per liter (mg/L) | Standard Deviation 34 |
| 600mg SC | Concentration of REGN10933 in Serum | 3 days Post-Dose | 41.0 milligrams per liter (mg/L) | Standard Deviation 19.3 |
| 600mg SC | Concentration of REGN10933 in Serum | 7 days Post-Dose | 54.6 milligrams per liter (mg/L) | Standard Deviation 19.9 |
| 600mg SC | Concentration of REGN10933 in Serum | 120 days Post-Dose | 5.64 milligrams per liter (mg/L) | Standard Deviation 3.77 |
| 600mg SC | Concentration of REGN10933 in Serum | 15 minutes Post-Dose | 3.89 milligrams per liter (mg/L) | Standard Deviation 19.7 |
| 600mg SC | Concentration of REGN10933 in Serum | Pre-dose | 0.395 milligrams per liter (mg/L) | Standard Deviation 4.96 |
Secondary
Concentration of REGN10987 in Serum
Time frame: Pre-Dose, 15 minutes Post-Dose, 3 days Post-Dose, 5 days Post-Dose, 7 days Post-Dose, 120 days Post-Dose
Population: Number Analyzed = number of participants contributing to each nominal timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo (IV + SC) | Concentration of REGN10987 in Serum | 7 days Post-Dose | 22.8 milligrams per liter (mg/L) | Standard Deviation 12.8 |
| Pooled Placebo (IV + SC) | Concentration of REGN10987 in Serum | 5 days Post-Dose | 26.6 milligrams per liter (mg/L) | Standard Deviation 15.5 |
| Pooled Placebo (IV + SC) | Concentration of REGN10987 in Serum | Pre-dose | 0.529 milligrams per liter (mg/L) | Standard Deviation 4.38 |
| Pooled Placebo (IV + SC) | Concentration of REGN10987 in Serum | 3 days Post-Dose | 32.6 milligrams per liter (mg/L) | Standard Deviation 15.9 |
| Pooled Placebo (IV + SC) | Concentration of REGN10987 in Serum | 15 minutes Post-Dose | 56.9 milligrams per liter (mg/L) | Standard Deviation 53.1 |
| Pooled Placebo (IV + SC) | Concentration of REGN10987 in Serum | 120 days Post-Dose | 1.02 milligrams per liter (mg/L) | Standard Deviation 0.805 |
| 300mg IV | Concentration of REGN10987 in Serum | 15 minutes Post-Dose | 95.4 milligrams per liter (mg/L) | Standard Deviation 59.4 |
| 300mg IV | Concentration of REGN10987 in Serum | 3 days Post-Dose | 56.0 milligrams per liter (mg/L) | Standard Deviation 18.9 |
| 300mg IV | Concentration of REGN10987 in Serum | 5 days Post-Dose | 46.3 milligrams per liter (mg/L) | Standard Deviation 15.9 |
| 300mg IV | Concentration of REGN10987 in Serum | 7 days Post-Dose | 38.0 milligrams per liter (mg/L) | Standard Deviation 11.2 |
| 300mg IV | Concentration of REGN10987 in Serum | 120 days Post-Dose | 1.97 milligrams per liter (mg/L) | Standard Deviation 1.38 |
| 300mg IV | Concentration of REGN10987 in Serum | Pre-dose | 2.04 milligrams per liter (mg/L) | Standard Deviation 12.7 |
| 600mg IV | Concentration of REGN10987 in Serum | Pre-dose | 0.823 milligrams per liter (mg/L) | Standard Deviation 6.48 |
| 600mg IV | Concentration of REGN10987 in Serum | 7 days Post-Dose | 77.7 milligrams per liter (mg/L) | Standard Deviation 24.3 |
| 600mg IV | Concentration of REGN10987 in Serum | 15 minutes Post-Dose | 178 milligrams per liter (mg/L) | Standard Deviation 119 |
| 600mg IV | Concentration of REGN10987 in Serum | 3 days Post-Dose | 109 milligrams per liter (mg/L) | Standard Deviation 38.5 |
| 600mg IV | Concentration of REGN10987 in Serum | 5 days Post-Dose | 87.1 milligrams per liter (mg/L) | Standard Deviation 26.9 |
| 600mg IV | Concentration of REGN10987 in Serum | 120 days Post-Dose | 3.80 milligrams per liter (mg/L) | Standard Deviation 3.1 |
| 1200mg IV | Concentration of REGN10987 in Serum | 120 days Post-Dose | 6.88 milligrams per liter (mg/L) | Standard Deviation 5.47 |
| 1200mg IV | Concentration of REGN10987 in Serum | 3 days Post-Dose | 225 milligrams per liter (mg/L) | Standard Deviation 62.3 |
| 1200mg IV | Concentration of REGN10987 in Serum | 7 days Post-Dose | 151 milligrams per liter (mg/L) | Standard Deviation 43.1 |
| 1200mg IV | Concentration of REGN10987 in Serum | 5 days Post-Dose | 177 milligrams per liter (mg/L) | Standard Deviation 50.9 |
| 1200mg IV | Concentration of REGN10987 in Serum | Pre-dose | 13.1 milligrams per liter (mg/L) | Standard Deviation 126 |
| 1200mg IV | Concentration of REGN10987 in Serum | 15 minutes Post-Dose | 383 milligrams per liter (mg/L) | Standard Deviation 273 |
| 2400mg IV | Concentration of REGN10987 in Serum | 120 days Post-Dose | 1.63 milligrams per liter (mg/L) | Standard Deviation 1.43 |
| 2400mg IV | Concentration of REGN10987 in Serum | 5 days Post-Dose | 25.6 milligrams per liter (mg/L) | Standard Deviation 9.31 |
| 2400mg IV | Concentration of REGN10987 in Serum | 7 days Post-Dose | 26.2 milligrams per liter (mg/L) | Standard Deviation 8.74 |
| 2400mg IV | Concentration of REGN10987 in Serum | Pre-dose | 1.02 milligrams per liter (mg/L) | Standard Deviation 12.8 |
| 2400mg IV | Concentration of REGN10987 in Serum | 15 minutes Post-Dose | 8.48 milligrams per liter (mg/L) | Standard Deviation 51.7 |
| 2400mg IV | Concentration of REGN10987 in Serum | 3 days Post-Dose | 21.8 milligrams per liter (mg/L) | Standard Deviation 16.2 |
| 600mg SC | Concentration of REGN10987 in Serum | 3 days Post-Dose | 42.0 milligrams per liter (mg/L) | Standard Deviation 20.1 |
| 600mg SC | Concentration of REGN10987 in Serum | 15 minutes Post-Dose | 4.36 milligrams per liter (mg/L) | Standard Deviation 21.6 |
| 600mg SC | Concentration of REGN10987 in Serum | 120 days Post-Dose | 3.26 milligrams per liter (mg/L) | Standard Deviation 2.49 |
| 600mg SC | Concentration of REGN10987 in Serum | 5 days Post-Dose | 52.9 milligrams per liter (mg/L) | Standard Deviation 29.1 |
| 600mg SC | Concentration of REGN10987 in Serum | Pre-dose | 0.370 milligrams per liter (mg/L) | Standard Deviation 4.64 |
| 600mg SC | Concentration of REGN10987 in Serum | 7 days Post-Dose | 53.7 milligrams per liter (mg/L) | Standard Deviation 17.9 |
Secondary
Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933
Time frame: Through day 120
Population: ADA analysis set includes all treated participants who received any amount of study drug and had at least one non-missing antibody variables result following the first dose of study drug or placebo.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pooled Placebo (IV + SC) | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 | Pre-existing Immunoreactivity | 3 Participants |
| Pooled Placebo (IV + SC) | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 | Treatment-Boosted Response | 0 Participants |
| Pooled Placebo (IV + SC) | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 | Treatment-Emergent Response | 4 Participants |
| Pooled Placebo (IV + SC) | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 | Negative | 142 Participants |
| 300mg IV | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 | Negative | 139 Participants |
| 300mg IV | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 | Treatment-Emergent Response | 11 Participants |
| 300mg IV | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 | Pre-existing Immunoreactivity | 2 Participants |
| 300mg IV | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 | Treatment-Boosted Response | 0 Participants |
| 600mg IV | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 | Treatment-Emergent Response | 6 Participants |
| 600mg IV | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 | Treatment-Boosted Response | 1 Participants |
| 600mg IV | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 | Pre-existing Immunoreactivity | 3 Participants |
| 600mg IV | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 | Negative | 128 Participants |
| 1200mg IV | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 | Pre-existing Immunoreactivity | 0 Participants |
| 1200mg IV | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 | Treatment-Boosted Response | 0 Participants |
| 1200mg IV | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 | Treatment-Emergent Response | 7 Participants |
| 1200mg IV | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 | Negative | 143 Participants |
| 2400mg IV | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 | Pre-existing Immunoreactivity | 2 Participants |
| 2400mg IV | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 | Negative | 147 Participants |
| 2400mg IV | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 | Treatment-Boosted Response | 0 Participants |
| 2400mg IV | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 | Treatment-Emergent Response | 1 Participants |
| 600mg SC | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 | Treatment-Boosted Response | 0 Participants |
| 600mg SC | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 | Pre-existing Immunoreactivity | 1 Participants |
| 600mg SC | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 | Treatment-Emergent Response | 14 Participants |
| 600mg SC | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 | Negative | 132 Participants |
| 1200mg SC | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 | Treatment-Emergent Response | 5 Participants |
| 1200mg SC | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 | Pre-existing Immunoreactivity | 3 Participants |
| 1200mg SC | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 | Treatment-Boosted Response | 0 Participants |
| 1200mg SC | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 | Negative | 133 Participants |
Secondary
Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987
Time frame: Through day 120
Population: ADA analysis set includes all treated participants who received any amount of study drug and had at least one non-missing antibody variables result following the first dose of study drug or placebo.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pooled Placebo (IV + SC) | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 | Pre-existing Immunoreactivity | 3 Participants |
| Pooled Placebo (IV + SC) | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 | Treatment-Boosted Response | 0 Participants |
| Pooled Placebo (IV + SC) | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 | Treatment-Emergent Response | 6 Participants |
| Pooled Placebo (IV + SC) | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 | Negative | 142 Participants |
| 300mg IV | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 | Negative | 131 Participants |
| 300mg IV | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 | Treatment-Emergent Response | 17 Participants |
| 300mg IV | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 | Pre-existing Immunoreactivity | 4 Participants |
| 300mg IV | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 | Treatment-Boosted Response | 0 Participants |
| 600mg IV | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 | Treatment-Emergent Response | 11 Participants |
| 600mg IV | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 | Treatment-Boosted Response | 1 Participants |
| 600mg IV | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 | Pre-existing Immunoreactivity | 0 Participants |
| 600mg IV | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 | Negative | 126 Participants |
| 1200mg IV | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 | Pre-existing Immunoreactivity | 3 Participants |
| 1200mg IV | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 | Treatment-Boosted Response | 1 Participants |
| 1200mg IV | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 | Treatment-Emergent Response | 13 Participants |
| 1200mg IV | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 | Negative | 133 Participants |
| 2400mg IV | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 | Pre-existing Immunoreactivity | 3 Participants |
| 2400mg IV | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 | Negative | 140 Participants |
| 2400mg IV | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 | Treatment-Boosted Response | 0 Participants |
| 2400mg IV | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 | Treatment-Emergent Response | 7 Participants |
| 600mg SC | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 | Treatment-Boosted Response | 0 Participants |
| 600mg SC | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 | Pre-existing Immunoreactivity | 3 Participants |
| 600mg SC | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 | Treatment-Emergent Response | 23 Participants |
| 600mg SC | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 | Negative | 121 Participants |
| 1200mg SC | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 | Treatment-Emergent Response | 14 Participants |
| 1200mg SC | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 | Pre-existing Immunoreactivity | 3 Participants |
| 1200mg SC | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 | Treatment-Boosted Response | 0 Participants |
| 1200mg SC | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 | Negative | 124 Participants |
Secondary
Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933
Time frame: Through day 120
Population: NAb analysis set includes all treated participants who received any study drug, had at least one non-missing antibody result following the first dose of study drug, and either tested negative at all ADA sampling times or tested positive for ADA with at least one non-missing NAb result after first dose of the study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pooled Placebo (IV + SC) | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933 | ADA Negative | 142 Participants |
| Pooled Placebo (IV + SC) | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933 | Treatment-emergent & Treatment-boosted; Positive in NAb assay | 0 Participants |
| Pooled Placebo (IV + SC) | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933 | Treatment-emergent & Treatment-boosted; Negative in NAb assay | 4 Participants |
| 300mg IV | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933 | Treatment-emergent & Treatment-boosted; Positive in NAb assay | 0 Participants |
| 300mg IV | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933 | Treatment-emergent & Treatment-boosted; Negative in NAb assay | 11 Participants |
| 300mg IV | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933 | ADA Negative | 139 Participants |
| 600mg IV | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933 | ADA Negative | 128 Participants |
| 600mg IV | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933 | Treatment-emergent & Treatment-boosted; Negative in NAb assay | 7 Participants |
| 600mg IV | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933 | Treatment-emergent & Treatment-boosted; Positive in NAb assay | 0 Participants |
| 1200mg IV | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933 | Treatment-emergent & Treatment-boosted; Positive in NAb assay | 1 Participants |
| 1200mg IV | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933 | Treatment-emergent & Treatment-boosted; Negative in NAb assay | 6 Participants |
| 1200mg IV | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933 | ADA Negative | 143 Participants |
| 2400mg IV | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933 | Treatment-emergent & Treatment-boosted; Positive in NAb assay | 1 Participants |
| 2400mg IV | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933 | Treatment-emergent & Treatment-boosted; Negative in NAb assay | 0 Participants |
| 2400mg IV | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933 | ADA Negative | 147 Participants |
| 600mg SC | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933 | Treatment-emergent & Treatment-boosted; Negative in NAb assay | 13 Participants |
| 600mg SC | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933 | ADA Negative | 132 Participants |
| 600mg SC | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933 | Treatment-emergent & Treatment-boosted; Positive in NAb assay | 1 Participants |
| 1200mg SC | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933 | ADA Negative | 133 Participants |
| 1200mg SC | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933 | Treatment-emergent & Treatment-boosted; Positive in NAb assay | 0 Participants |
| 1200mg SC | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933 | Treatment-emergent & Treatment-boosted; Negative in NAb assay | 5 Participants |
Secondary
Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987
Time frame: Through day 120
Population: NAb analysis set includes all treated participants who received any study drug, had at least one non-missing antibody result following the first dose of study drug, and either tested negative at all ADA sampling times or tested positive for ADA with at least one non-missing NAb result after first dose of the study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pooled Placebo (IV + SC) | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 | Pre-existing Immunoreactivity; Negative in NAb assay | 1 Participants |
| Pooled Placebo (IV + SC) | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 | Treatment-emergent & Treatment-boosted; Negative in NAb assay | 5 Participants |
| Pooled Placebo (IV + SC) | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 | Treatment-emergent & Treatment-boosted; Positive in NAb assay | 1 Participants |
| Pooled Placebo (IV + SC) | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 | ADA Negative | 140 Participants |
| 300mg IV | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 | ADA Negative | 131 Participants |
| 300mg IV | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 | Treatment-emergent & Treatment-boosted; Positive in NAb assay | 7 Participants |
| 300mg IV | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 | Pre-existing Immunoreactivity; Negative in NAb assay | 2 Participants |
| 300mg IV | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 | Treatment-emergent & Treatment-boosted; Negative in NAb assay | 10 Participants |
| 600mg IV | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 | Treatment-emergent & Treatment-boosted; Positive in NAb assay | 5 Participants |
| 600mg IV | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 | Treatment-emergent & Treatment-boosted; Negative in NAb assay | 7 Participants |
| 600mg IV | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 | Pre-existing Immunoreactivity; Negative in NAb assay | 0 Participants |
| 600mg IV | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 | ADA Negative | 126 Participants |
| 1200mg IV | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 | Pre-existing Immunoreactivity; Negative in NAb assay | 2 Participants |
| 1200mg IV | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 | Treatment-emergent & Treatment-boosted; Negative in NAb assay | 10 Participants |
| 1200mg IV | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 | Treatment-emergent & Treatment-boosted; Positive in NAb assay | 4 Participants |
| 1200mg IV | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 | ADA Negative | 133 Participants |
| 2400mg IV | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 | Pre-existing Immunoreactivity; Negative in NAb assay | 1 Participants |
| 2400mg IV | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 | ADA Negative | 140 Participants |
| 2400mg IV | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 | Treatment-emergent & Treatment-boosted; Negative in NAb assay | 5 Participants |
| 2400mg IV | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 | Treatment-emergent & Treatment-boosted; Positive in NAb assay | 2 Participants |
| 600mg SC | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 | Treatment-emergent & Treatment-boosted; Negative in NAb assay | 17 Participants |
| 600mg SC | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 | Pre-existing Immunoreactivity; Negative in NAb assay | 2 Participants |
| 600mg SC | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 | Treatment-emergent & Treatment-boosted; Positive in NAb assay | 6 Participants |
| 600mg SC | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 | ADA Negative | 121 Participants |
| 1200mg SC | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 | Treatment-emergent & Treatment-boosted; Positive in NAb assay | 4 Participants |
| 1200mg SC | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 | Pre-existing Immunoreactivity; Negative in NAb assay | 3 Participants |
| 1200mg SC | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 | Treatment-emergent & Treatment-boosted; Negative in NAb assay | 10 Participants |
| 1200mg SC | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 | ADA Negative | 124 Participants |
Secondary
Number of Participants With High Viral Load
Number of participants with viral load greater than 10,000 copies/mL, as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.
Time frame: Day 1, Day 3, Day 5, Day 7, Day 15, Day 22
Population: Seronegative modified Full Analysis Set (Seronegative mFAS): Participants in the Full Analysis Set (Overall mFAS) who were seronegative at baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pooled Placebo (IV + SC) | Number of Participants With High Viral Load | Day 15 Viral Load >10^5 copies/mL | 4 Participants |
| Pooled Placebo (IV + SC) | Number of Participants With High Viral Load | Day 3 Viral Load >10^5 copies/mL | 83 Participants |
| Pooled Placebo (IV + SC) | Number of Participants With High Viral Load | Day 5 Viral Load >10^4 copies/mL | 78 Participants |
| Pooled Placebo (IV + SC) | Number of Participants With High Viral Load | Day 3 Viral Load >10^6 copies/mL | 59 Participants |
| Pooled Placebo (IV + SC) | Number of Participants With High Viral Load | Day 3 Viral Load >10^7 copies/mL | 29 Participants |
| Pooled Placebo (IV + SC) | Number of Participants With High Viral Load | Day 22 Viral Load >10^5 copies/mL | 2 Participants |
| Pooled Placebo (IV + SC) | Number of Participants With High Viral Load | Day 5 Viral Load >10^5 copies/mL | 53 Participants |
| Pooled Placebo (IV + SC) | Number of Participants With High Viral Load | Day 22 Viral Load >10^4 copies/mL | 3 Participants |
| Pooled Placebo (IV + SC) | Number of Participants With High Viral Load | Day 15 Viral Load >10^4 copies/mL | 8 Participants |
| Pooled Placebo (IV + SC) | Number of Participants With High Viral Load | Day 15 Viral Load >10^6 copies/mL | 1 Participants |
| Pooled Placebo (IV + SC) | Number of Participants With High Viral Load | Day 22 Viral Load >10^7 copies/mL | 0 Participants |
| Pooled Placebo (IV + SC) | Number of Participants With High Viral Load | Day 7 Viral Load >10^7 copies/mL | 5 Participants |
| Pooled Placebo (IV + SC) | Number of Participants With High Viral Load | Day 15 Viral Load >10^7 copies/mL | 0 Participants |
| Pooled Placebo (IV + SC) | Number of Participants With High Viral Load | Day 7 Viral Load >10^6 copies/mL | 13 Participants |
| Pooled Placebo (IV + SC) | Number of Participants With High Viral Load | Day 22 Viral Load >10^6 copies/mL | 1 Participants |
| Pooled Placebo (IV + SC) | Number of Participants With High Viral Load | Day 5 Viral Load >10^7 copies/mL | 14 Participants |
| Pooled Placebo (IV + SC) | Number of Participants With High Viral Load | Day 1 Viral Load >10^4 copies/mL | 108 Participants |
| Pooled Placebo (IV + SC) | Number of Participants With High Viral Load | Day 1 Viral Load >10^5 copies/mL | 104 Participants |
| Pooled Placebo (IV + SC) | Number of Participants With High Viral Load | Day 7 Viral Load >10^5 copies/mL | 32 Participants |
| Pooled Placebo (IV + SC) | Number of Participants With High Viral Load | Day 1 Viral Load >10^6 copies/mL | 88 Participants |
| Pooled Placebo (IV + SC) | Number of Participants With High Viral Load | Day 7 Viral Load >10^4 copies/mL | 59 Participants |
| Pooled Placebo (IV + SC) | Number of Participants With High Viral Load | Day 1 Viral Load >10^7 copies/mL | 60 Participants |
| Pooled Placebo (IV + SC) | Number of Participants With High Viral Load | Day 5 Viral Load >10^6 copies/mL | 29 Participants |
| Pooled Placebo (IV + SC) | Number of Participants With High Viral Load | Day 3 Viral Load >10^4 copies/mL | 93 Participants |
| 300mg IV | Number of Participants With High Viral Load | Day 1 Viral Load >10^6 copies/mL | 83 Participants |
| 300mg IV | Number of Participants With High Viral Load | Day 15 Viral Load >10^6 copies/mL | 1 Participants |
| 300mg IV | Number of Participants With High Viral Load | Day 22 Viral Load >10^7 copies/mL | 0 Participants |
| 300mg IV | Number of Participants With High Viral Load | Day 7 Viral Load >10^7 copies/mL | 1 Participants |
| 300mg IV | Number of Participants With High Viral Load | Day 7 Viral Load >10^4 copies/mL | 32 Participants |
| 300mg IV | Number of Participants With High Viral Load | Day 15 Viral Load >10^7 copies/mL | 1 Participants |
| 300mg IV | Number of Participants With High Viral Load | Day 7 Viral Load >10^6 copies/mL | 2 Participants |
| 300mg IV | Number of Participants With High Viral Load | Day 5 Viral Load >10^5 copies/mL | 31 Participants |
| 300mg IV | Number of Participants With High Viral Load | Day 22 Viral Load >10^6 copies/mL | 0 Participants |
| 300mg IV | Number of Participants With High Viral Load | Day 1 Viral Load >10^7 copies/mL | 67 Participants |
| 300mg IV | Number of Participants With High Viral Load | Day 3 Viral Load >10^6 copies/mL | 47 Participants |
| 300mg IV | Number of Participants With High Viral Load | Day 1 Viral Load >10^4 copies/mL | 106 Participants |
| 300mg IV | Number of Participants With High Viral Load | Day 5 Viral Load >10^7 copies/mL | 0 Participants |
| 300mg IV | Number of Participants With High Viral Load | Day 22 Viral Load >10^5 copies/mL | 0 Participants |
| 300mg IV | Number of Participants With High Viral Load | Day 1 Viral Load >10^5 copies/mL | 99 Participants |
| 300mg IV | Number of Participants With High Viral Load | Day 3 Viral Load >10^5 copies/mL | 68 Participants |
| 300mg IV | Number of Participants With High Viral Load | Day 15 Viral Load >10^4 copies/mL | 3 Participants |
| 300mg IV | Number of Participants With High Viral Load | Day 5 Viral Load >10^4 copies/mL | 65 Participants |
| 300mg IV | Number of Participants With High Viral Load | Day 3 Viral Load >10^7 copies/mL | 15 Participants |
| 300mg IV | Number of Participants With High Viral Load | Day 7 Viral Load >10^5 copies/mL | 9 Participants |
| 300mg IV | Number of Participants With High Viral Load | Day 5 Viral Load >10^6 copies/mL | 7 Participants |
| 300mg IV | Number of Participants With High Viral Load | Day 22 Viral Load >10^4 copies/mL | 0 Participants |
| 300mg IV | Number of Participants With High Viral Load | Day 15 Viral Load >10^5 copies/mL | 1 Participants |
| 300mg IV | Number of Participants With High Viral Load | Day 3 Viral Load >10^4 copies/mL | 92 Participants |
| 600mg IV | Number of Participants With High Viral Load | Day 7 Viral Load >10^7 copies/mL | 0 Participants |
| 600mg IV | Number of Participants With High Viral Load | Day 1 Viral Load >10^6 copies/mL | 86 Participants |
| 600mg IV | Number of Participants With High Viral Load | Day 5 Viral Load >10^4 copies/mL | 58 Participants |
| 600mg IV | Number of Participants With High Viral Load | Day 15 Viral Load >10^6 copies/mL | 1 Participants |
| 600mg IV | Number of Participants With High Viral Load | Day 3 Viral Load >10^4 copies/mL | 79 Participants |
| 600mg IV | Number of Participants With High Viral Load | Day 15 Viral Load >10^5 copies/mL | 2 Participants |
| 600mg IV | Number of Participants With High Viral Load | Day 3 Viral Load >10^5 copies/mL | 63 Participants |
| 600mg IV | Number of Participants With High Viral Load | Day 7 Viral Load >10^6 copies/mL | 1 Participants |
| 600mg IV | Number of Participants With High Viral Load | Day 5 Viral Load >10^5 copies/mL | 20 Participants |
| 600mg IV | Number of Participants With High Viral Load | Day 22 Viral Load >10^4 copies/mL | 3 Participants |
| 600mg IV | Number of Participants With High Viral Load | Day 15 Viral Load >10^7 copies/mL | 0 Participants |
| 600mg IV | Number of Participants With High Viral Load | Day 22 Viral Load >10^5 copies/mL | 0 Participants |
| 600mg IV | Number of Participants With High Viral Load | Day 22 Viral Load >10^7 copies/mL | 0 Participants |
| 600mg IV | Number of Participants With High Viral Load | Day 5 Viral Load >10^6 copies/mL | 9 Participants |
| 600mg IV | Number of Participants With High Viral Load | Day 1 Viral Load >10^5 copies/mL | 92 Participants |
| 600mg IV | Number of Participants With High Viral Load | Day 3 Viral Load >10^7 copies/mL | 15 Participants |
| 600mg IV | Number of Participants With High Viral Load | Day 22 Viral Load >10^6 copies/mL | 0 Participants |
| 600mg IV | Number of Participants With High Viral Load | Day 5 Viral Load >10^7 copies/mL | 3 Participants |
| 600mg IV | Number of Participants With High Viral Load | Day 3 Viral Load >10^6 copies/mL | 43 Participants |
| 600mg IV | Number of Participants With High Viral Load | Day 1 Viral Load >10^7 copies/mL | 64 Participants |
| 600mg IV | Number of Participants With High Viral Load | Day 15 Viral Load >10^4 copies/mL | 6 Participants |
| 600mg IV | Number of Participants With High Viral Load | Day 1 Viral Load >10^4 copies/mL | 96 Participants |
| 600mg IV | Number of Participants With High Viral Load | Day 7 Viral Load >10^4 copies/mL | 35 Participants |
| 600mg IV | Number of Participants With High Viral Load | Day 7 Viral Load >10^5 copies/mL | 9 Participants |
| 1200mg IV | Number of Participants With High Viral Load | Day 7 Viral Load >10^5 copies/mL | 7 Participants |
| 1200mg IV | Number of Participants With High Viral Load | Day 3 Viral Load >10^4 copies/mL | 80 Participants |
| 1200mg IV | Number of Participants With High Viral Load | Day 5 Viral Load >10^7 copies/mL | 0 Participants |
| 1200mg IV | Number of Participants With High Viral Load | Day 15 Viral Load >10^4 copies/mL | 7 Participants |
| 1200mg IV | Number of Participants With High Viral Load | Day 15 Viral Load >10^5 copies/mL | 3 Participants |
| 1200mg IV | Number of Participants With High Viral Load | Day 15 Viral Load >10^6 copies/mL | 0 Participants |
| 1200mg IV | Number of Participants With High Viral Load | Day 15 Viral Load >10^7 copies/mL | 0 Participants |
| 1200mg IV | Number of Participants With High Viral Load | Day 22 Viral Load >10^6 copies/mL | 0 Participants |
| 1200mg IV | Number of Participants With High Viral Load | Day 1 Viral Load >10^4 copies/mL | 95 Participants |
| 1200mg IV | Number of Participants With High Viral Load | Day 1 Viral Load >10^5 copies/mL | 89 Participants |
| 1200mg IV | Number of Participants With High Viral Load | Day 1 Viral Load >10^6 copies/mL | 76 Participants |
| 1200mg IV | Number of Participants With High Viral Load | Day 1 Viral Load >10^7 copies/mL | 54 Participants |
| 1200mg IV | Number of Participants With High Viral Load | Day 3 Viral Load >10^5 copies/mL | 67 Participants |
| 1200mg IV | Number of Participants With High Viral Load | Day 3 Viral Load >10^6 copies/mL | 36 Participants |
| 1200mg IV | Number of Participants With High Viral Load | Day 3 Viral Load >10^7 copies/mL | 14 Participants |
| 1200mg IV | Number of Participants With High Viral Load | Day 5 Viral Load >10^4 copies/mL | 58 Participants |
| 1200mg IV | Number of Participants With High Viral Load | Day 5 Viral Load >10^5 copies/mL | 30 Participants |
| 1200mg IV | Number of Participants With High Viral Load | Day 5 Viral Load >10^6 copies/mL | 3 Participants |
| 1200mg IV | Number of Participants With High Viral Load | Day 7 Viral Load >10^4 copies/mL | 27 Participants |
| 1200mg IV | Number of Participants With High Viral Load | Day 7 Viral Load >10^6 copies/mL | 0 Participants |
| 1200mg IV | Number of Participants With High Viral Load | Day 7 Viral Load >10^7 copies/mL | 0 Participants |
| 1200mg IV | Number of Participants With High Viral Load | Day 22 Viral Load >10^4 copies/mL | 0 Participants |
| 1200mg IV | Number of Participants With High Viral Load | Day 22 Viral Load >10^5 copies/mL | 0 Participants |
| 1200mg IV | Number of Participants With High Viral Load | Day 22 Viral Load >10^7 copies/mL | 0 Participants |
| 2400mg IV | Number of Participants With High Viral Load | Day 22 Viral Load >10^5 copies/mL | 1 Participants |
| 2400mg IV | Number of Participants With High Viral Load | Day 15 Viral Load >10^5 copies/mL | 1 Participants |
| 2400mg IV | Number of Participants With High Viral Load | Day 3 Viral Load >10^4 copies/mL | 80 Participants |
| 2400mg IV | Number of Participants With High Viral Load | Day 1 Viral Load >10^5 copies/mL | 84 Participants |
| 2400mg IV | Number of Participants With High Viral Load | Day 7 Viral Load >10^7 copies/mL | 0 Participants |
| 2400mg IV | Number of Participants With High Viral Load | Day 22 Viral Load >10^6 copies/mL | 1 Participants |
| 2400mg IV | Number of Participants With High Viral Load | Day 7 Viral Load >10^5 copies/mL | 13 Participants |
| 2400mg IV | Number of Participants With High Viral Load | Day 1 Viral Load >10^7 copies/mL | 58 Participants |
| 2400mg IV | Number of Participants With High Viral Load | Day 15 Viral Load >10^6 copies/mL | 1 Participants |
| 2400mg IV | Number of Participants With High Viral Load | Day 5 Viral Load >10^7 copies/mL | 0 Participants |
| 2400mg IV | Number of Participants With High Viral Load | Day 15 Viral Load >10^7 copies/mL | 0 Participants |
| 2400mg IV | Number of Participants With High Viral Load | Day 7 Viral Load >10^6 copies/mL | 0 Participants |
| 2400mg IV | Number of Participants With High Viral Load | Day 1 Viral Load >10^4 copies/mL | 91 Participants |
| 2400mg IV | Number of Participants With High Viral Load | Day 3 Viral Load >10^7 copies/mL | 14 Participants |
| 2400mg IV | Number of Participants With High Viral Load | Day 5 Viral Load >10^6 copies/mL | 10 Participants |
| 2400mg IV | Number of Participants With High Viral Load | Day 3 Viral Load >10^5 copies/mL | 61 Participants |
| 2400mg IV | Number of Participants With High Viral Load | Day 15 Viral Load >10^4 copies/mL | 7 Participants |
| 2400mg IV | Number of Participants With High Viral Load | Day 3 Viral Load >10^6 copies/mL | 39 Participants |
| 2400mg IV | Number of Participants With High Viral Load | Day 22 Viral Load >10^4 copies/mL | 4 Participants |
| 2400mg IV | Number of Participants With High Viral Load | Day 5 Viral Load >10^5 copies/mL | 29 Participants |
| 2400mg IV | Number of Participants With High Viral Load | Day 1 Viral Load >10^6 copies/mL | 78 Participants |
| 2400mg IV | Number of Participants With High Viral Load | Day 22 Viral Load >10^7 copies/mL | 1 Participants |
| 2400mg IV | Number of Participants With High Viral Load | Day 5 Viral Load >10^4 copies/mL | 55 Participants |
| 2400mg IV | Number of Participants With High Viral Load | Day 7 Viral Load >10^4 copies/mL | 28 Participants |
| 600mg SC | Number of Participants With High Viral Load | Day 22 Viral Load >10^6 copies/mL | 0 Participants |
| 600mg SC | Number of Participants With High Viral Load | Day 5 Viral Load >10^4 copies/mL | 62 Participants |
| 600mg SC | Number of Participants With High Viral Load | Day 3 Viral Load >10^4 copies/mL | 89 Participants |
| 600mg SC | Number of Participants With High Viral Load | Day 5 Viral Load >10^5 copies/mL | 29 Participants |
| 600mg SC | Number of Participants With High Viral Load | Day 1 Viral Load >10^7 copies/mL | 63 Participants |
| 600mg SC | Number of Participants With High Viral Load | Day 5 Viral Load >10^6 copies/mL | 7 Participants |
| 600mg SC | Number of Participants With High Viral Load | Day 5 Viral Load >10^7 copies/mL | 5 Participants |
| 600mg SC | Number of Participants With High Viral Load | Day 1 Viral Load >10^6 copies/mL | 81 Participants |
| 600mg SC | Number of Participants With High Viral Load | Day 1 Viral Load >10^4 copies/mL | 99 Participants |
| 600mg SC | Number of Participants With High Viral Load | Day 7 Viral Load >10^4 copies/mL | 33 Participants |
| 600mg SC | Number of Participants With High Viral Load | Day 1 Viral Load >10^5 copies/mL | 93 Participants |
| 600mg SC | Number of Participants With High Viral Load | Day 7 Viral Load >10^5 copies/mL | 9 Participants |
| 600mg SC | Number of Participants With High Viral Load | Day 15 Viral Load >10^7 copies/mL | 0 Participants |
| 600mg SC | Number of Participants With High Viral Load | Day 7 Viral Load >10^6 copies/mL | 2 Participants |
| 600mg SC | Number of Participants With High Viral Load | Day 15 Viral Load >10^6 copies/mL | 1 Participants |
| 600mg SC | Number of Participants With High Viral Load | Day 7 Viral Load >10^7 copies/mL | 0 Participants |
| 600mg SC | Number of Participants With High Viral Load | Day 15 Viral Load >10^5 copies/mL | 1 Participants |
| 600mg SC | Number of Participants With High Viral Load | Day 15 Viral Load >10^4 copies/mL | 4 Participants |
| 600mg SC | Number of Participants With High Viral Load | Day 22 Viral Load >10^4 copies/mL | 1 Participants |
| 600mg SC | Number of Participants With High Viral Load | Day 3 Viral Load >10^7 copies/mL | 25 Participants |
| 600mg SC | Number of Participants With High Viral Load | Day 22 Viral Load >10^7 copies/mL | 0 Participants |
| 600mg SC | Number of Participants With High Viral Load | Day 22 Viral Load >10^5 copies/mL | 1 Participants |
| 600mg SC | Number of Participants With High Viral Load | Day 3 Viral Load >10^6 copies/mL | 41 Participants |
| 600mg SC | Number of Participants With High Viral Load | Day 3 Viral Load >10^5 copies/mL | 68 Participants |
| 1200mg SC | Number of Participants With High Viral Load | Day 15 Viral Load >10^7 copies/mL | 0 Participants |
| 1200mg SC | Number of Participants With High Viral Load | Day 7 Viral Load >10^4 copies/mL | 35 Participants |
| 1200mg SC | Number of Participants With High Viral Load | Day 15 Viral Load >10^4 copies/mL | 4 Participants |
| 1200mg SC | Number of Participants With High Viral Load | Day 3 Viral Load >10^5 copies/mL | 75 Participants |
| 1200mg SC | Number of Participants With High Viral Load | Day 1 Viral Load >10^5 copies/mL | 95 Participants |
| 1200mg SC | Number of Participants With High Viral Load | Day 5 Viral Load >10^7 copies/mL | 2 Participants |
| 1200mg SC | Number of Participants With High Viral Load | Day 22 Viral Load >10^5 copies/mL | 0 Participants |
| 1200mg SC | Number of Participants With High Viral Load | Day 22 Viral Load >10^4 copies/mL | 3 Participants |
| 1200mg SC | Number of Participants With High Viral Load | Day 5 Viral Load >10^6 copies/mL | 9 Participants |
| 1200mg SC | Number of Participants With High Viral Load | Day 1 Viral Load >10^6 copies/mL | 88 Participants |
| 1200mg SC | Number of Participants With High Viral Load | Day 3 Viral Load >10^7 copies/mL | 23 Participants |
| 1200mg SC | Number of Participants With High Viral Load | Day 5 Viral Load >10^4 copies/mL | 67 Participants |
| 1200mg SC | Number of Participants With High Viral Load | Day 5 Viral Load >10^5 copies/mL | 31 Participants |
| 1200mg SC | Number of Participants With High Viral Load | Day 15 Viral Load >10^6 copies/mL | 0 Participants |
| 1200mg SC | Number of Participants With High Viral Load | Day 1 Viral Load >10^7 copies/mL | 62 Participants |
| 1200mg SC | Number of Participants With High Viral Load | Day 7 Viral Load >10^6 copies/mL | 1 Participants |
| 1200mg SC | Number of Participants With High Viral Load | Day 3 Viral Load >10^6 copies/mL | 53 Participants |
| 1200mg SC | Number of Participants With High Viral Load | Day 7 Viral Load >10^5 copies/mL | 9 Participants |
| 1200mg SC | Number of Participants With High Viral Load | Day 15 Viral Load >10^5 copies/mL | 0 Participants |
| 1200mg SC | Number of Participants With High Viral Load | Day 22 Viral Load >10^7 copies/mL | 0 Participants |
| 1200mg SC | Number of Participants With High Viral Load | Day 1 Viral Load >10^4 copies/mL | 106 Participants |
| 1200mg SC | Number of Participants With High Viral Load | Day 3 Viral Load >10^4 copies/mL | 89 Participants |
| 1200mg SC | Number of Participants With High Viral Load | Day 7 Viral Load >10^7 copies/mL | 1 Participants |
| 1200mg SC | Number of Participants With High Viral Load | Day 22 Viral Load >10^6 copies/mL | 0 Participants |
Secondary
Number of Participants With Hypersensitivity Reactions Grade 2 or Above
Time frame: Through day 29
Population: Safety Analysis Set (SAF): Randomized participants who received any study drug; based on the treatment received (as treated)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pooled Placebo (IV + SC) | Number of Participants With Hypersensitivity Reactions Grade 2 or Above | 0 Participants |
| 300mg IV | Number of Participants With Hypersensitivity Reactions Grade 2 or Above | 0 Participants |
| 600mg IV | Number of Participants With Hypersensitivity Reactions Grade 2 or Above | 1 Participants |
| 1200mg IV | Number of Participants With Hypersensitivity Reactions Grade 2 or Above | 0 Participants |
| 2400mg IV | Number of Participants With Hypersensitivity Reactions Grade 2 or Above | 0 Participants |
| 600mg SC | Number of Participants With Hypersensitivity Reactions Grade 2 or Above | 0 Participants |
| 1200mg SC | Number of Participants With Hypersensitivity Reactions Grade 2 or Above | 0 Participants |
| 1200mg SC | Number of Participants With Hypersensitivity Reactions Grade 2 or Above | 1 Participants |
Secondary
Number of Participants With Infusion-Related Reactions Grade 2 or Above
Time frame: Through day 4
Population: Safety Analysis Set (SAF): Randomized participants who received any study drug; based on the treatment received (as treated)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pooled Placebo (IV + SC) | Number of Participants With Infusion-Related Reactions Grade 2 or Above | 0 Participants |
| 300mg IV | Number of Participants With Infusion-Related Reactions Grade 2 or Above | 0 Participants |
| 600mg IV | Number of Participants With Infusion-Related Reactions Grade 2 or Above | 0 Participants |
| 1200mg IV | Number of Participants With Infusion-Related Reactions Grade 2 or Above | 0 Participants |
| 2400mg IV | Number of Participants With Infusion-Related Reactions Grade 2 or Above | 0 Participants |
| 600mg SC | Number of Participants With Infusion-Related Reactions Grade 2 or Above | 0 Participants |
| 1200mg SC | Number of Participants With Infusion-Related Reactions Grade 2 or Above | 0 Participants |
| 1200mg SC | Number of Participants With Infusion-Related Reactions Grade 2 or Above | 0 Participants |
Secondary
Number of Participants With Injection-Site Reactions Grade 3 or Above
Time frame: Through day 4
Population: Safety Analysis Set (SAF): Randomized participants who received any study drug; based on the treatment received (as treated)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pooled Placebo (IV + SC) | Number of Participants With Injection-Site Reactions Grade 3 or Above | 0 Participants |
| 300mg IV | Number of Participants With Injection-Site Reactions Grade 3 or Above | 0 Participants |
| 600mg IV | Number of Participants With Injection-Site Reactions Grade 3 or Above | 0 Participants |
| 1200mg IV | Number of Participants With Injection-Site Reactions Grade 3 or Above | 0 Participants |
| 2400mg IV | Number of Participants With Injection-Site Reactions Grade 3 or Above | 0 Participants |
| 600mg SC | Number of Participants With Injection-Site Reactions Grade 3 or Above | 0 Participants |
| 1200mg SC | Number of Participants With Injection-Site Reactions Grade 3 or Above | 0 Participants |
| 1200mg SC | Number of Participants With Injection-Site Reactions Grade 3 or Above | 0 Participants |
Secondary
Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs)
Time frame: Through day 29
Population: Safety Analysis Set (SAF): Randomized participants who received any study drug; based on the treatment received (as treated)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pooled Placebo (IV + SC) | Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs) | 0 Participants |
| 300mg IV | Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs) | 0 Participants |
| 600mg IV | Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs) | 0 Participants |
| 1200mg IV | Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs) | 0 Participants |
| 2400mg IV | Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs) | 2 Participants |
| 600mg SC | Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs) | 0 Participants |
| 1200mg SC | Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs) | 0 Participants |
| 1200mg SC | Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs) | 1 Participants |
Secondary
Number of Participants With Viral Loads Below the Limit of Detection
Number of participants with viral load less than 299 copies/mL, as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.
Time frame: Day 1, Day 3, Day 5, Day 7, Day 15, Day 22
Population: Seronegative modified Full Analysis Set (Seronegative mFAS): Participants in the Full Analysis Set (Overall mFAS) who were seronegative at baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pooled Placebo (IV + SC) | Number of Participants With Viral Loads Below the Limit of Detection | Day 22 | 73 Participants |
| Pooled Placebo (IV + SC) | Number of Participants With Viral Loads Below the Limit of Detection | Day 3 | 3 Participants |
| Pooled Placebo (IV + SC) | Number of Participants With Viral Loads Below the Limit of Detection | Day 5 | 6 Participants |
| Pooled Placebo (IV + SC) | Number of Participants With Viral Loads Below the Limit of Detection | Day 15 | 55 Participants |
| Pooled Placebo (IV + SC) | Number of Participants With Viral Loads Below the Limit of Detection | Day 7 | 19 Participants |
| Pooled Placebo (IV + SC) | Number of Participants With Viral Loads Below the Limit of Detection | Day 1 | 0 Participants |
| 300mg IV | Number of Participants With Viral Loads Below the Limit of Detection | Day 1 | 0 Participants |
| 300mg IV | Number of Participants With Viral Loads Below the Limit of Detection | Day 22 | 78 Participants |
| 300mg IV | Number of Participants With Viral Loads Below the Limit of Detection | Day 7 | 22 Participants |
| 300mg IV | Number of Participants With Viral Loads Below the Limit of Detection | Day 5 | 11 Participants |
| 300mg IV | Number of Participants With Viral Loads Below the Limit of Detection | Day 15 | 68 Participants |
| 300mg IV | Number of Participants With Viral Loads Below the Limit of Detection | Day 3 | 1 Participants |
| 600mg IV | Number of Participants With Viral Loads Below the Limit of Detection | Day 5 | 10 Participants |
| 600mg IV | Number of Participants With Viral Loads Below the Limit of Detection | Day 1 | 0 Participants |
| 600mg IV | Number of Participants With Viral Loads Below the Limit of Detection | Day 15 | 58 Participants |
| 600mg IV | Number of Participants With Viral Loads Below the Limit of Detection | Day 22 | 74 Participants |
| 600mg IV | Number of Participants With Viral Loads Below the Limit of Detection | Day 3 | 4 Participants |
| 600mg IV | Number of Participants With Viral Loads Below the Limit of Detection | Day 7 | 16 Participants |
| 1200mg IV | Number of Participants With Viral Loads Below the Limit of Detection | Day 22 | 70 Participants |
| 1200mg IV | Number of Participants With Viral Loads Below the Limit of Detection | Day 3 | 3 Participants |
| 1200mg IV | Number of Participants With Viral Loads Below the Limit of Detection | Day 7 | 14 Participants |
| 1200mg IV | Number of Participants With Viral Loads Below the Limit of Detection | Day 5 | 12 Participants |
| 1200mg IV | Number of Participants With Viral Loads Below the Limit of Detection | Day 1 | 0 Participants |
| 1200mg IV | Number of Participants With Viral Loads Below the Limit of Detection | Day 15 | 54 Participants |
| 2400mg IV | Number of Participants With Viral Loads Below the Limit of Detection | Day 15 | 50 Participants |
| 2400mg IV | Number of Participants With Viral Loads Below the Limit of Detection | Day 22 | 62 Participants |
| 2400mg IV | Number of Participants With Viral Loads Below the Limit of Detection | Day 7 | 18 Participants |
| 2400mg IV | Number of Participants With Viral Loads Below the Limit of Detection | Day 3 | 1 Participants |
| 2400mg IV | Number of Participants With Viral Loads Below the Limit of Detection | Day 5 | 12 Participants |
| 2400mg IV | Number of Participants With Viral Loads Below the Limit of Detection | Day 1 | 0 Participants |
| 600mg SC | Number of Participants With Viral Loads Below the Limit of Detection | Day 22 | 81 Participants |
| 600mg SC | Number of Participants With Viral Loads Below the Limit of Detection | Day 3 | 1 Participants |
| 600mg SC | Number of Participants With Viral Loads Below the Limit of Detection | Day 7 | 25 Participants |
| 600mg SC | Number of Participants With Viral Loads Below the Limit of Detection | Day 15 | 67 Participants |
| 600mg SC | Number of Participants With Viral Loads Below the Limit of Detection | Day 5 | 11 Participants |
| 600mg SC | Number of Participants With Viral Loads Below the Limit of Detection | Day 1 | 0 Participants |
| 1200mg SC | Number of Participants With Viral Loads Below the Limit of Detection | Day 7 | 19 Participants |
| 1200mg SC | Number of Participants With Viral Loads Below the Limit of Detection | Day 5 | 12 Participants |
| 1200mg SC | Number of Participants With Viral Loads Below the Limit of Detection | Day 22 | 84 Participants |
| 1200mg SC | Number of Participants With Viral Loads Below the Limit of Detection | Day 15 | 65 Participants |
| 1200mg SC | Number of Participants With Viral Loads Below the Limit of Detection | Day 3 | 5 Participants |
| 1200mg SC | Number of Participants With Viral Loads Below the Limit of Detection | Day 1 | 0 Participants |
Secondary
Number of Participants With Viral Loads Below the Lower Limit of Quantification
Number of participants with viral load less than 714 copies/mL, as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.
Time frame: Day 1, Day 3, Day 5, Day 7, Day 15, Day 22
Population: Seronegative modified Full Analysis Set (Seronegative mFAS): Participants in the Full Analysis Set (Overall mFAS) who were seronegative at baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pooled Placebo (IV + SC) | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 7 | 25 Participants |
| Pooled Placebo (IV + SC) | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 5 | 8 Participants |
| Pooled Placebo (IV + SC) | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 3 | 4 Participants |
| Pooled Placebo (IV + SC) | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 1 | 0 Participants |
| Pooled Placebo (IV + SC) | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 22 | 84 Participants |
| Pooled Placebo (IV + SC) | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 15 | 69 Participants |
| 300mg IV | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 1 | 1 Participants |
| 300mg IV | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 3 | 5 Participants |
| 300mg IV | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 15 | 78 Participants |
| 300mg IV | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 5 | 17 Participants |
| 300mg IV | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 22 | 87 Participants |
| 300mg IV | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 7 | 33 Participants |
| 600mg IV | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 22 | 83 Participants |
| 600mg IV | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 1 | 0 Participants |
| 600mg IV | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 15 | 69 Participants |
| 600mg IV | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 7 | 24 Participants |
| 600mg IV | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 5 | 14 Participants |
| 600mg IV | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 3 | 4 Participants |
| 1200mg IV | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 5 | 20 Participants |
| 1200mg IV | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 3 | 6 Participants |
| 1200mg IV | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 22 | 81 Participants |
| 1200mg IV | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 1 | 0 Participants |
| 1200mg IV | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 7 | 26 Participants |
| 1200mg IV | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 15 | 67 Participants |
| 2400mg IV | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 3 | 2 Participants |
| 2400mg IV | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 7 | 24 Participants |
| 2400mg IV | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 1 | 0 Participants |
| 2400mg IV | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 22 | 74 Participants |
| 2400mg IV | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 15 | 62 Participants |
| 2400mg IV | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 5 | 14 Participants |
| 600mg SC | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 1 | 3 Participants |
| 600mg SC | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 5 | 15 Participants |
| 600mg SC | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 22 | 87 Participants |
| 600mg SC | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 7 | 38 Participants |
| 600mg SC | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 3 | 1 Participants |
| 600mg SC | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 15 | 76 Participants |
| 1200mg SC | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 1 | 0 Participants |
| 1200mg SC | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 15 | 83 Participants |
| 1200mg SC | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 22 | 95 Participants |
| 1200mg SC | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 5 | 14 Participants |
| 1200mg SC | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 7 | 27 Participants |
| 1200mg SC | Number of Participants With Viral Loads Below the Lower Limit of Quantification | Day 3 | 7 Participants |
Secondary
Time-Weighted Average Daily Change From Day 1 in Viral Load
Time-weighted average daily change from Day 1 in viral load (log10 copies/mL) as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.
Time frame: Day 1 to Day 5
Population: Seronegative modified Full Analysis Set (Seronegative mFAS): Participants in the Full Analysis Set (Overall mFAS) who were seronegative at baseline
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pooled Placebo (IV + SC) | Time-Weighted Average Daily Change From Day 1 in Viral Load | -1.19 log10 copies/mL | Standard Error 0.09 |
| 300mg IV | Time-Weighted Average Daily Change From Day 1 in Viral Load | -1.66 log10 copies/mL | Standard Error 0.09 |
| 600mg IV | Time-Weighted Average Daily Change From Day 1 in Viral Load | -1.76 log10 copies/mL | Standard Error 0.09 |
| 1200mg IV | Time-Weighted Average Daily Change From Day 1 in Viral Load | -1.77 log10 copies/mL | Standard Error 0.09 |
| 2400mg IV | Time-Weighted Average Daily Change From Day 1 in Viral Load | -1.68 log10 copies/mL | Standard Error 0.1 |
| 600mg SC | Time-Weighted Average Daily Change From Day 1 in Viral Load | -1.56 log10 copies/mL | Standard Error 0.09 |
| 1200mg SC | Time-Weighted Average Daily Change From Day 1 in Viral Load | -1.61 log10 copies/mL | Standard Error 0.09 |
p-value: 0.000295% CI: [-0.72, -0.23]ANCOVA
p-value: <0.000195% CI: [-0.82, -0.32]ANCOVA
p-value: <0.000195% CI: [-0.83, -0.33]ANCOVA
p-value: 0.000295% CI: [-0.75, -0.24]ANCOVA
p-value: 0.00495% CI: [-0.62, -0.12]ANCOVA
p-value: 0.000795% CI: [-0.67, -0.18]ANCOVA
Secondary
Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline
Time-weighted average daily change from Day 1 in viral load (log10 copies/mL) as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples. in any participant with a viral load greater than 10,000 copies/mL at baseline.
Time frame: Day 1 to Day 7
Population: Overall modified Full Analysis Set (Overall mFAS): All randomized participants with a positive central-lab determined SARS-CoV-2 RT-qPCR result from NP swab samples at randomization; based on the treatment received (as treated)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo (IV + SC) | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^4 copies/mL | -1.79 log10 copies/mL | Standard Error 0.09 |
| Pooled Placebo (IV + SC) | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^5 copies/mL | -1.82 log10 copies/mL | Standard Error 0.09 |
| Pooled Placebo (IV + SC) | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^6 copies/mL | -1.92 log10 copies/mL | Standard Error 0.1 |
| Pooled Placebo (IV + SC) | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^7 copies/mL | -1.89 log10 copies/mL | Standard Error 0.11 |
| 300mg IV | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^7 copies/mL | -2.77 log10 copies/mL | Standard Error 0.11 |
| 300mg IV | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^6 copies/mL | -2.62 log10 copies/mL | Standard Error 0.1 |
| 300mg IV | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^4 copies/mL | -2.36 log10 copies/mL | Standard Error 0.09 |
| 300mg IV | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^5 copies/mL | -2.47 log10 copies/mL | Standard Error 0.09 |
| 600mg IV | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^6 copies/mL | -2.63 log10 copies/mL | Standard Error 0.1 |
| 600mg IV | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^5 copies/mL | -2.51 log10 copies/mL | Standard Error 0.1 |
| 600mg IV | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^4 copies/mL | -2.37 log10 copies/mL | Standard Error 0.09 |
| 600mg IV | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^7 copies/mL | -2.83 log10 copies/mL | Standard Error 0.11 |
| 1200mg IV | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^4 copies/mL | -2.41 log10 copies/mL | Standard Error 0.09 |
| 1200mg IV | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^5 copies/mL | -2.49 log10 copies/mL | Standard Error 0.09 |
| 1200mg IV | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^6 copies/mL | -2.64 log10 copies/mL | Standard Error 0.1 |
| 1200mg IV | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^7 copies/mL | -2.82 log10 copies/mL | Standard Error 0.12 |
| 2400mg IV | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^4 copies/mL | -2.34 log10 copies/mL | Standard Error 0.09 |
| 2400mg IV | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^7 copies/mL | -2.72 log10 copies/mL | Standard Error 0.11 |
| 2400mg IV | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^5 copies/mL | -2.46 log10 copies/mL | Standard Error 0.09 |
| 2400mg IV | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^6 copies/mL | -2.62 log10 copies/mL | Standard Error 0.1 |
| 600mg SC | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^5 copies/mL | -2.40 log10 copies/mL | Standard Error 0.09 |
| 600mg SC | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^4 copies/mL | -2.30 log10 copies/mL | Standard Error 0.09 |
| 600mg SC | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^6 copies/mL | -2.47 log10 copies/mL | Standard Error 0.1 |
| 600mg SC | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^7 copies/mL | -2.52 log10 copies/mL | Standard Error 0.11 |
| 1200mg SC | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^6 copies/mL | -2.52 log10 copies/mL | Standard Error 0.1 |
| 1200mg SC | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^4 copies/mL | -2.27 log10 copies/mL | Standard Error 0.09 |
| 1200mg SC | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^5 copies/mL | -2.38 log10 copies/mL | Standard Error 0.09 |
| 1200mg SC | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^7 copies/mL | -2.73 log10 copies/mL | Standard Error 0.11 |
Comparison: Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: <0.000195% CI: [-0.82, -0.33]ANCOVA
Comparison: Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: <0.000195% CI: [-0.9, -0.4]ANCOVA
Comparison: Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: <0.000195% CI: [-0.97, -0.42]ANCOVA
Comparison: Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: <0.000195% CI: [-1.19, -0.58]ANCOVA
Comparison: Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: <0.000195% CI: [-0.84, -0.33]ANCOVA
Comparison: Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: <0.000195% CI: [-0.95, -0.43]ANCOVA
Comparison: Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: <0.000195% CI: [-0.98, -0.44]ANCOVA
Comparison: Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: <0.000195% CI: [-1.25, -0.64]ANCOVA
Comparison: Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: <0.000195% CI: [-0.87, -0.37]ANCOVA
Comparison: Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: <0.000195% CI: [-0.93, -0.42]ANCOVA
Comparison: Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: <0.000195% CI: [-0.99, -0.44]ANCOVA
Comparison: Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: <0.000195% CI: [-1.25, -0.61]ANCOVA
Comparison: Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: <0.000195% CI: [-0.8, -0.31]ANCOVA
Comparison: Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: <0.000195% CI: [-0.89, -0.38]ANCOVA
Comparison: Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: <0.000195% CI: [-0.97, -0.43]ANCOVA
Comparison: Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: <0.000195% CI: [-1.15, -0.52]ANCOVA
Comparison: Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: <0.000195% CI: [-0.76, -0.27]ANCOVA
Comparison: Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: <0.000195% CI: [-0.83, -0.33]ANCOVA
Comparison: Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: <0.000195% CI: [-0.82, -0.28]ANCOVA
Comparison: Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: <0.000195% CI: [-0.95, -0.32]ANCOVA
Comparison: Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: 0.000295% CI: [-0.73, -0.23]ANCOVA
Comparison: Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: <0.000195% CI: [-0.82, -0.31]ANCOVA
Comparison: Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: <0.000195% CI: [-0.87, -0.33]ANCOVA
Comparison: Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: <0.000195% CI: [-1.16, -0.52]ANCOVA
Secondary
Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline
Time-weighted average daily change from Day 1 in viral load (log10 copies/mL) as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples. in any participant with a viral load greater than 10,000 copies/mL at baseline.
Time frame: Day 1 to Day 5
Population: Overall modified Full Analysis Set (Overall mFAS): All randomized participants with a positive central-lab determined SARS-CoV-2 RT-qPCR result from NP swab samples at randomization; based on the treatment received (as treated)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo (IV + SC) | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^4 copies/mL | -1.28 log10 copies/mL | Standard Error 0.08 |
| Pooled Placebo (IV + SC) | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^6 copies/mL | -1.38 log10 copies/mL | Standard Error 0.09 |
| Pooled Placebo (IV + SC) | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^7 copies/mL | -1.39 log10 copies/mL | Standard Error 0.11 |
| Pooled Placebo (IV + SC) | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^5 copies/mL | -1.30 log10 copies/mL | Standard Error 0.08 |
| 300mg IV | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^4 copies/mL | -1.69 log10 copies/mL | Standard Error 0.08 |
| 300mg IV | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^5 copies/mL | -1.77 log10 copies/mL | Standard Error 0.08 |
| 300mg IV | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^6 copies/mL | -1.89 log10 copies/mL | Standard Error 0.09 |
| 300mg IV | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^7 copies/mL | -1.99 log10 copies/mL | Standard Error 0.1 |
| 600mg IV | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^4 copies/mL | -1.73 log10 copies/mL | Standard Error 0.09 |
| 600mg IV | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^7 copies/mL | -2.08 log10 copies/mL | Standard Error 0.1 |
| 600mg IV | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^6 copies/mL | -1.92 log10 copies/mL | Standard Error 0.09 |
| 600mg IV | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^5 copies/mL | -1.83 log10 copies/mL | Standard Error 0.09 |
| 1200mg IV | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^7 copies/mL | -2.08 log10 copies/mL | Standard Error 0.11 |
| 1200mg IV | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^4 copies/mL | -1.76 log10 copies/mL | Standard Error 0.09 |
| 1200mg IV | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^5 copies/mL | -1.81 log10 copies/mL | Standard Error 0.09 |
| 1200mg IV | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^6 copies/mL | -1.93 log10 copies/mL | Standard Error 0.09 |
| 2400mg IV | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^6 copies/mL | -1.91 log10 copies/mL | Standard Error 0.09 |
| 2400mg IV | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^4 copies/mL | -1.68 log10 copies/mL | Standard Error 0.08 |
| 2400mg IV | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^7 copies/mL | -2.01 log10 copies/mL | Standard Error 0.1 |
| 2400mg IV | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^5 copies/mL | -1.76 log10 copies/mL | Standard Error 0.09 |
| 600mg SC | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^5 copies/mL | -1.69 log10 copies/mL | Standard Error 0.08 |
| 600mg SC | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^6 copies/mL | -1.76 log10 copies/mL | Standard Error 0.09 |
| 600mg SC | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^4 copies/mL | -1.62 log10 copies/mL | Standard Error 0.08 |
| 600mg SC | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^7 copies/mL | -1.76 log10 copies/mL | Standard Error 0.1 |
| 1200mg SC | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^7 copies/mL | -1.97 log10 copies/mL | Standard Error 0.1 |
| 1200mg SC | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^4 copies/mL | -1.61 log10 copies/mL | Standard Error 0.08 |
| 1200mg SC | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^5 copies/mL | -1.69 log10 copies/mL | Standard Error 0.09 |
| 1200mg SC | Time-Weighted Average Daily Change From Day 1 in Viral Load in Participants With High Viral Load at Baseline | Baseline Viral Load is >10^6 copies/mL | -1.79 log10 copies/mL | Standard Error 0.09 |
Comparison: Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: 0.000595% CI: [-0.64, -0.18]ANCOVA
Comparison: Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: <0.000195% CI: [-0.69, -0.23]ANCOVA
Comparison: Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: <0.000195% CI: [-0.75, -0.26]ANCOVA
Comparison: Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: <0.000195% CI: [-0.88, -0.32]ANCOVA
Comparison: Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: 0.000395% CI: [-0.69, -0.21]ANCOVA
Comparison: Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: <0.000195% CI: [-0.77, -0.29]ANCOVA
Comparison: Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: <0.000195% CI: [-0.78, -0.29]ANCOVA
Comparison: Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: <0.000195% CI: [-0.98, -0.41]ANCOVA
Comparison: Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: <0.000195% CI: [-0.72, -0.25]ANCOVA
Comparison: Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: <0.000195% CI: [-0.74, -0.28]ANCOVA
Comparison: Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: <0.000195% CI: [-0.79, -0.3]ANCOVA
Comparison: Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: <0.000195% CI: [-0.99, -0.4]ANCOVA
Comparison: Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: 0.000995% CI: [-0.63, -0.16]ANCOVA
Comparison: Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: 0.000195% CI: [-0.69, -0.23]ANCOVA
Comparison: Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: <0.000195% CI: [-0.77, -0.27]ANCOVA
Comparison: Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: <0.000195% CI: [-0.92, -0.34]ANCOVA
Comparison: Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: 0.004695% CI: [-0.57, -0.1]ANCOVA
Comparison: Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: 0.001195% CI: [-0.62, -0.15]ANCOVA
Comparison: Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: 0.002995% CI: [-0.62, -0.13]ANCOVA
Comparison: Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: 0.01295% CI: [-0.66, -0.08]ANCOVA
Comparison: Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: 0.006295% CI: [-0.56, -0.09]ANCOVA
Comparison: Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: 0.001195% CI: [-0.62, -0.16]ANCOVA
Comparison: Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: 0.001195% CI: [-0.66, -0.17]ANCOVA
Comparison: Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)p-value: 0.000195% CI: [-0.87, -0.29]ANCOVA