| 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. | Seronegative modified Full Analysis Set (Seronegative mFAS): Participants in the Full Analysis Set (Overall mFAS) who were seronegative at baseline | Posted | | Least Squares Mean | Standard Error | log10 copies/mL | | Day 1 to Day 7 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Placebo (IV + SC) | Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987 | | OG001 | 300mg IV | Participants received a single 300mg intravenous dose of REGN10933+REGN10987 | | OG002 | 600mg IV | Participants received a single 600mg intravenous dose of REGN10933+REGN10987 | | OG003 | 1200mg IV | Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 | | OG004 | 2400mg IV | Participants received a single 2400mg intravenous dose of REGN10933+REGN10987 | | OG005 | 600mg SC | Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987 | | OG006 | 1200mg SC | Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987 |
| | Units | Counts |
|---|
| Participants | - OG00074
- OG00176
- OG00266
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-1.68± 0.11
- OG001-2.25± 0.11
- OG002-2.34± 0.12
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Difference vs. Placebo (log10 copies/mL) | ANCOVA | | 0.0004 | | Difference of LS Means | -0.57 | Standard Error of the Mean | 0.16 | 2-Sided | 95 | -0.88 | -0.25 | | | | | Superiority | | | | Difference vs. Placebo (log10 copies/mL) |
|
| 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. | Seronegative modified Full Analysis Set (Seronegative mFAS): Participants in the Full Analysis Set (Overall mFAS) who were seronegative at baseline | Posted | | Least Squares Mean | Standard Error | log10 copies/mL | | Day 1 to Day 5 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Placebo (IV + SC) | Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987 | | OG001 | 300mg IV | Participants received a single 300mg intravenous dose of REGN10933+REGN10987 | | OG002 | 600mg IV | Participants received a single 600mg intravenous dose of REGN10933+REGN10987 | | OG003 | 1200mg IV | Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 |
|
| 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. | 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) | Posted | | Least Squares Mean | Standard Error | log10 copies/mL | | Day 1 to Day 7 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Placebo (IV + SC) | Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987 | | OG001 | 300mg IV | Participants received a single 300mg intravenous dose of REGN10933+REGN10987 | | OG002 | 600mg IV | Participants received a single 600mg intravenous dose of REGN10933+REGN10987 | |
|
| 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. | 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) | Posted | | Least Squares Mean | Standard Error | log10 copies/mL | | Day 1 to Day 5 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Placebo (IV + SC) | Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987 | | OG001 | 300mg IV | Participants received a single 300mg intravenous dose of REGN10933+REGN10987 | | OG002 | 600mg IV | Participants received a single 600mg intravenous dose of REGN10933+REGN10987 | |
|
| 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. | Seronegative modified Full Analysis Set (Seronegative mFAS): Participants in the Full Analysis Set (Overall mFAS) who were seronegative at baseline | Posted | | Count of Participants | | Participants | | Day 1, Day 3, Day 5, Day 7, Day 15, Day 22 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Placebo (IV + SC) | Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987 | | OG001 | 300mg IV | Participants received a single 300mg intravenous dose of REGN10933+REGN10987 | | OG002 | 600mg IV | Participants received a single 600mg intravenous dose of REGN10933+REGN10987 | | OG003 | 1200mg IV | Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 |
|
| 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. | Seronegative modified Full Analysis Set (Seronegative mFAS): Participants in the Full Analysis Set (Overall mFAS) who were seronegative at baseline | Posted | | Count of Participants | | Participants | | Day 1, Day 3, Day 5, Day 7, Day 15, Day 22 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Placebo (IV + SC) | Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987 | | OG001 | 300mg IV | Participants received a single 300mg intravenous dose of REGN10933+REGN10987 | | OG002 | 600mg IV | Participants received a single 600mg intravenous dose of REGN10933+REGN10987 | | OG003 | 1200mg IV | Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 |
|
| 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. | Seronegative modified Full Analysis Set (Seronegative mFAS): Participants in the Full Analysis Set (Overall mFAS) who were seronegative at baseline | Posted | | Count of Participants | | Participants | | Day 1, Day 3, Day 5, Day 7, Day 15, Day 22 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Placebo (IV + SC) | Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987 | | OG001 | 300mg IV | Participants received a single 300mg intravenous dose of REGN10933+REGN10987 | | OG002 | 600mg IV | Participants received a single 600mg intravenous dose of REGN10933+REGN10987 | | OG003 | 1200mg IV | Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 |
|
| 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 | Seronegative modified Full Analysis Set (Seronegative mFAS): Participants in the Full Analysis Set (Overall mFAS) who were seronegative at baseline | Posted | | Least Squares Mean | Standard Error | log10 copies/mL | | Day 3, Day 5, Day 7, Day 15, Day 22 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Placebo (IV + SC) | Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987 | | OG001 | 300mg IV | Participants received a single 300mg intravenous dose of REGN10933+REGN10987 | | OG002 | 600mg IV | Participants received a single 600mg intravenous dose of REGN10933+REGN10987 | | OG003 | 1200mg IV | Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 |
|
| Secondary | Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs) | | Safety Analysis Set (SAF): Randomized participants who received any study drug; based on the treatment received (as treated) | Posted | | Count of Participants | | Participants | | Through day 29 | | | | ID | Title | Description |
|---|
| OG000 | Placebo IV Dose | Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 | | OG001 | 300mg IV | Participants received a single 300mg intravenous dose of REGN10933+REGN10987 | | OG002 | 600mg IV | Participants received a single 600mg intravenous dose of REGN10933+REGN10987 | | OG003 | 1200mg IV | Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 | | OG004 | 2400mg IV | Participants received a single 2400mg intravenous dose of REGN10933+REGN10987 |
|
| Secondary | Number of Participants With Infusion-Related Reactions Grade 2 or Above | | Safety Analysis Set (SAF): Randomized participants who received any study drug; based on the treatment received (as treated) | Posted | | Count of Participants | | Participants | | Through day 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo IV Dose | Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 | | OG001 | 300mg IV | Participants received a single 300mg intravenous dose of REGN10933+REGN10987 | | OG002 | 600mg IV | Participants received a single 600mg intravenous dose of REGN10933+REGN10987 | | OG003 | 1200mg IV | Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 | | OG004 | 2400mg IV | Participants received a single 2400mg intravenous dose of REGN10933+REGN10987 |
|
| Secondary | Number of Participants With Injection-Site Reactions Grade 3 or Above | | Safety Analysis Set (SAF): Randomized participants who received any study drug; based on the treatment received (as treated) | Posted | | Count of Participants | | Participants | | Through day 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo IV Dose | Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 | | OG001 | 300mg IV | Participants received a single 300mg intravenous dose of REGN10933+REGN10987 | | OG002 | 600mg IV | Participants received a single 600mg intravenous dose of REGN10933+REGN10987 | | OG003 | 1200mg IV | Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 | | OG004 | 2400mg IV | Participants received a single 2400mg intravenous dose of REGN10933+REGN10987 |
|
| Secondary | Number of Participants With Hypersensitivity Reactions Grade 2 or Above | | Safety Analysis Set (SAF): Randomized participants who received any study drug; based on the treatment received (as treated) | Posted | | Count of Participants | | Participants | | Through day 29 | | | | ID | Title | Description |
|---|
| OG000 | Placebo IV Dose | Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 | | OG001 | 300mg IV | Participants received a single 300mg intravenous dose of REGN10933+REGN10987 | | OG002 | 600mg IV | Participants received a single 600mg intravenous dose of REGN10933+REGN10987 | | OG003 | 1200mg IV | Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 | | OG004 | 2400mg IV | Participants received a single 2400mg intravenous dose of REGN10933+REGN10987 |
|
| Secondary | Concentration of REGN10933 in Serum | | Number Analyzed = number of participants contributing to each nominal timepoint | Posted | | Mean | Standard Deviation | milligrams per liter (mg/L) | | Pre-Dose, 15 minutes Post-Dose, 3 days Post-Dose, 5 days Post-Dose, 7 days Post-Dose, 120 days Post-Dose | | | | ID | Title | Description |
|---|
| OG000 | 300mg IV | Participants received a single 300mg intravenous dose of REGN10933+REGN10987 | | OG001 | 600mg IV | Participants received a single 600mg intravenous dose of REGN10933+REGN10987 | | OG002 | 1200mg IV | Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 | | OG003 | 2400mg IV | Participants received a single 2400mg intravenous dose of REGN10933+REGN10987 | | OG004 | 600mg SC | Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987 |
|
| Secondary | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 | | 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. | Posted | | Count of Participants | | Participants | | Through day 120 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Placebo (IV + SC) | Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987 | | OG001 | 300mg IV | Participants received a single 300mg intravenous dose of REGN10933+REGN10987 | | OG002 | 600mg IV | Participants received a single 600mg intravenous dose of REGN10933+REGN10987 | | OG003 | 1200mg IV | Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 | | OG004 | 2400mg IV |
|
| Secondary | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933 | | 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. | Posted | | Count of Participants | | Participants | | Through day 120 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Placebo (IV + SC) | Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987 | | OG001 | 300mg IV | Participants received a single 300mg intravenous dose of REGN10933+REGN10987 | | OG002 | 600mg IV | Participants received a single 600mg intravenous dose of REGN10933+REGN10987 | | OG003 | 1200mg IV | Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 |
|
| Secondary | Concentration of REGN10987 in Serum | | Number Analyzed = number of participants contributing to each nominal timepoint | Posted | | Mean | Standard Deviation | milligrams per liter (mg/L) | | Pre-Dose, 15 minutes Post-Dose, 3 days Post-Dose, 5 days Post-Dose, 7 days Post-Dose, 120 days Post-Dose | | | | ID | Title | Description |
|---|
| OG000 | 300mg IV | Participants received a single 300mg intravenous dose of REGN10933+REGN10987 | | OG001 | 600mg IV | Participants received a single 600mg intravenous dose of REGN10933+REGN10987 | | OG002 | 1200mg IV | Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 | | OG003 | 2400mg IV | Participants received a single 2400mg intravenous dose of REGN10933+REGN10987 | | OG004 | 600mg SC | Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987 |
|
| Secondary | Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 | | 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. | Posted | | Count of Participants | | Participants | | Through day 120 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Placebo (IV + SC) | Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987 | | OG001 | 300mg IV | Participants received a single 300mg intravenous dose of REGN10933+REGN10987 | | OG002 | 600mg IV | Participants received a single 600mg intravenous dose of REGN10933+REGN10987 | | OG003 | 1200mg IV | Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 | | OG004 | 2400mg IV |
|
| Secondary | Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 | | 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. | Posted | | Count of Participants | | Participants | | Through day 120 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Placebo (IV + SC) | Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987 | | OG001 | 300mg IV | Participants received a single 300mg intravenous dose of REGN10933+REGN10987 | | OG002 | 600mg IV | Participants received a single 600mg intravenous dose of REGN10933+REGN10987 | | OG003 | 1200mg IV | Participants received a single 1200mg intravenous dose of REGN10933+REGN10987 |
|