Trial Outcomes & Findings for COVID-19 Study Assessing the Virologic Efficacy of REGN10933+REGN10987 Across Different Dose Regimens in Adult Outpatients With SARS-CoV-2 Infection (NCT NCT04666441)

Last Updated: 2022-04-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

1149 participants

Primary outcome timeframe

Day 1 to Day 7

Results posted on

2022-04-08

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Placebo IV Dose Participants received a single intravenous dose of placebo matching REGN10933+REGN10987	300mg IV Participants received a single 300mg intravenous dose of REGN10933+REGN10987	600mg IV Participants received a single 600mg intravenous dose of REGN10933+REGN10987	1200mg IV Participants received a single 1200mg intravenous dose of REGN10933+REGN10987	2400mg IV Participants received a single 2400mg intravenous dose of REGN10933+REGN10987	Placebo SC Dose Participants received a single subcutaneous dose of placebo matching REGN10933+REGN10987	600mg SC Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987	1200mg SC Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
Overall Study STARTED	82	165	162	165	166	82	163	164
Overall Study COMPLETED	80	160	158	161	166	79	158	160
Overall Study NOT COMPLETED	2	5	4	4	0	3	5	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo IV Dose Participants received a single intravenous dose of placebo matching REGN10933+REGN10987	300mg IV Participants received a single 300mg intravenous dose of REGN10933+REGN10987	600mg IV Participants received a single 600mg intravenous dose of REGN10933+REGN10987	1200mg IV Participants received a single 1200mg intravenous dose of REGN10933+REGN10987	2400mg IV Participants received a single 2400mg intravenous dose of REGN10933+REGN10987	Placebo SC Dose Participants received a single subcutaneous dose of placebo matching REGN10933+REGN10987	600mg SC Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987	1200mg SC Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
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

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) results from central lab

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo IV Dose n=82 Participants Participants received a single intravenous dose of placebo matching REGN10933+REGN10987	300mg IV n=165 Participants Participants received a single 300mg intravenous dose of REGN10933+REGN10987	600mg IV n=162 Participants Participants received a single 600mg intravenous dose of REGN10933+REGN10987	1200mg IV n=165 Participants Participants received a single 1200mg intravenous dose of REGN10933+REGN10987	2400mg IV n=166 Participants Participants received a single 2400mg intravenous dose of REGN10933+REGN10987	Placebo SC Dose n=82 Participants Participants received a single subcutaneous dose of placebo matching REGN10933+REGN10987	600mg SC n=163 Participants Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987	1200mg SC n=164 Participants Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987	Total n=1149 Participants Total of all reporting groups
Age, Continuous	33.5 years STANDARD_DEVIATION 10.15 • n=82 Participants	33.9 years STANDARD_DEVIATION 8.99 • n=165 Participants	34.2 years STANDARD_DEVIATION 10.08 • n=162 Participants	34.4 years STANDARD_DEVIATION 9.81 • n=165 Participants	33.9 years STANDARD_DEVIATION 9.24 • n=166 Participants	36.3 years STANDARD_DEVIATION 9.88 • n=82 Participants	33.5 years STANDARD_DEVIATION 9.50 • n=163 Participants	33.0 years STANDARD_DEVIATION 10.18 • n=164 Participants	34.0 years STANDARD_DEVIATION 9.70 • n=1149 Participants
Sex: Female, Male Female	51 Participants n=82 Participants	87 Participants n=165 Participants	73 Participants n=162 Participants	92 Participants n=165 Participants	91 Participants n=166 Participants	39 Participants n=82 Participants	82 Participants n=163 Participants	85 Participants n=164 Participants	600 Participants n=1149 Participants
Sex: Female, Male Male	31 Participants n=82 Participants	78 Participants n=165 Participants	89 Participants n=162 Participants	73 Participants n=165 Participants	75 Participants n=166 Participants	43 Participants n=82 Participants	81 Participants n=163 Participants	79 Participants n=164 Participants	549 Participants n=1149 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	26 Participants n=82 Participants	67 Participants n=165 Participants	58 Participants n=162 Participants	60 Participants n=165 Participants	73 Participants n=166 Participants	32 Participants n=82 Participants	68 Participants n=163 Participants	62 Participants n=164 Participants	446 Participants n=1149 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	55 Participants n=82 Participants	96 Participants n=165 Participants	98 Participants n=162 Participants	102 Participants n=165 Participants	91 Participants n=166 Participants	49 Participants n=82 Participants	94 Participants n=163 Participants	99 Participants n=164 Participants	684 Participants n=1149 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=82 Participants	2 Participants n=165 Participants	6 Participants n=162 Participants	3 Participants n=165 Participants	2 Participants n=166 Participants	1 Participants n=82 Participants	1 Participants n=163 Participants	3 Participants n=164 Participants	19 Participants n=1149 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=82 Participants	2 Participants n=165 Participants	2 Participants n=162 Participants	0 Participants n=165 Participants	0 Participants n=166 Participants	0 Participants n=82 Participants	1 Participants n=163 Participants	0 Participants n=164 Participants	5 Participants n=1149 Participants
Race (NIH/OMB) Asian	11 Participants n=82 Participants	6 Participants n=165 Participants	7 Participants n=162 Participants	12 Participants n=165 Participants	3 Participants n=166 Participants	4 Participants n=82 Participants	12 Participants n=163 Participants	12 Participants n=164 Participants	67 Participants n=1149 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=82 Participants	0 Participants n=165 Participants	1 Participants n=162 Participants	2 Participants n=165 Participants	0 Participants n=166 Participants	0 Participants n=82 Participants	0 Participants n=163 Participants	0 Participants n=164 Participants	3 Participants n=1149 Participants
Race (NIH/OMB) Black or African American	3 Participants n=82 Participants	11 Participants n=165 Participants	8 Participants n=162 Participants	13 Participants n=165 Participants	17 Participants n=166 Participants	2 Participants n=82 Participants	7 Participants n=163 Participants	11 Participants n=164 Participants	72 Participants n=1149 Participants
Race (NIH/OMB) White	66 Participants n=82 Participants	141 Participants n=165 Participants	138 Participants n=162 Participants	131 Participants n=165 Participants	141 Participants n=166 Participants	72 Participants n=82 Participants	141 Participants n=163 Participants	136 Participants n=164 Participants	966 Participants n=1149 Participants
Race (NIH/OMB) More than one race	0 Participants n=82 Participants	0 Participants n=165 Participants	0 Participants n=162 Participants	0 Participants n=165 Participants	0 Participants n=166 Participants	0 Participants n=82 Participants	0 Participants n=163 Participants	0 Participants n=164 Participants	0 Participants n=1149 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=82 Participants	5 Participants n=165 Participants	6 Participants n=162 Participants	7 Participants n=165 Participants	5 Participants n=166 Participants	4 Participants n=82 Participants	2 Participants n=163 Participants	5 Participants n=164 Participants	36 Participants n=1149 Participants
Viral Load in Nasopharyngeal Swab Samples	5.98 log10 copies/mL STANDARD_DEVIATION 2.753 • n=80 Participants • Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) results from central lab	6.20 log10 copies/mL STANDARD_DEVIATION 2.697 • n=162 Participants • Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) results from central lab	5.70 log10 copies/mL STANDARD_DEVIATION 3.171 • n=161 Participants • Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) results from central lab	5.87 log10 copies/mL STANDARD_DEVIATION 2.656 • n=164 Participants • Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) results from central lab	6.12 log10 copies/mL STANDARD_DEVIATION 2.521 • n=164 Participants • Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) results from central lab	6.28 log10 copies/mL STANDARD_DEVIATION 2.521 • n=81 Participants • Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) results from central lab	6.15 log10 copies/mL STANDARD_DEVIATION 2.481 • n=162 Participants • Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) results from central lab	5.90 log10 copies/mL STANDARD_DEVIATION 2.832 • n=164 Participants • Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) results from central lab	6.01 log10 copies/mL STANDARD_DEVIATION 2.719 • n=1138 Participants • Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) results from central lab

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Pooled Placebo (IV + SC) n=74 Participants Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987	300mg IV n=76 Participants Participants received a single 300mg intravenous dose of REGN10933+REGN10987	600mg IV n=66 Participants Participants received a single 600mg intravenous dose of REGN10933+REGN10987	1200mg IV n=67 Participants Participants received a single 1200mg intravenous dose of REGN10933+REGN10987	2400mg IV n=61 Participants Participants received a single 2400mg intravenous dose of REGN10933+REGN10987	600mg SC n=71 Participants Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987	1200mg SC n=71 Participants Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987	1200mg SC Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
Time-Weighted Average Daily Change From Day 1 in Viral Load in NP Swab Samples	-1.68 log10 copies/mL Standard Error 0.11	-2.25 log10 copies/mL Standard Error 0.11	-2.34 log10 copies/mL Standard Error 0.12	-2.24 log10 copies/mL Standard Error 0.12	-2.40 log10 copies/mL Standard Error 0.12	-2.24 log10 copies/mL Standard Error 0.12	-2.24 log10 copies/mL Standard Error 0.12	—

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Pooled Placebo (IV + SC) n=105 Participants Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987	300mg IV n=104 Participants Participants received a single 300mg intravenous dose of REGN10933+REGN10987	600mg IV n=96 Participants Participants received a single 600mg intravenous dose of REGN10933+REGN10987	1200mg IV n=94 Participants Participants received a single 1200mg intravenous dose of REGN10933+REGN10987	2400mg IV n=90 Participants Participants received a single 2400mg intravenous dose of REGN10933+REGN10987	600mg SC n=99 Participants Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987	1200mg SC n=107 Participants Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987	1200mg SC Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
Time-Weighted Average Daily Change From Day 1 in Viral Load	-1.19 log10 copies/mL Standard Error 0.09	-1.66 log10 copies/mL Standard Error 0.09	-1.76 log10 copies/mL Standard Error 0.09	-1.77 log10 copies/mL Standard Error 0.09	-1.68 log10 copies/mL Standard Error 0.10	-1.56 log10 copies/mL Standard Error 0.09	-1.61 log10 copies/mL Standard Error 0.09	—

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Pooled Placebo (IV + SC) n=134 Participants Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987	300mg IV n=136 Participants Participants received a single 300mg intravenous dose of REGN10933+REGN10987	600mg IV n=119 Participants Participants received a single 600mg intravenous dose of REGN10933+REGN10987	1200mg IV n=128 Participants Participants received a single 1200mg intravenous dose of REGN10933+REGN10987	2400mg IV n=136 Participants Participants received a single 2400mg intravenous dose of REGN10933+REGN10987	600mg SC n=133 Participants Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987	1200mg SC n=130 Participants Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987	1200mg SC Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
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	-2.36 log10 copies/mL Standard Error 0.09	-2.37 log10 copies/mL Standard Error 0.09	-2.41 log10 copies/mL Standard Error 0.09	-2.34 log10 copies/mL Standard Error 0.09	-2.30 log10 copies/mL Standard Error 0.09	-2.27 log10 copies/mL Standard Error 0.09	—
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	-2.47 log10 copies/mL Standard Error 0.09	-2.51 log10 copies/mL Standard Error 0.10	-2.49 log10 copies/mL Standard Error 0.09	-2.46 log10 copies/mL Standard Error 0.09	-2.40 log10 copies/mL Standard Error 0.09	-2.38 log10 copies/mL Standard Error 0.09	—
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 0.10	-2.62 log10 copies/mL Standard Error 0.10	-2.63 log10 copies/mL Standard Error 0.10	-2.64 log10 copies/mL Standard Error 0.10	-2.62 log10 copies/mL Standard Error 0.10	-2.47 log10 copies/mL Standard Error 0.10	-2.52 log10 copies/mL Standard Error 0.10	—
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	-2.77 log10 copies/mL Standard Error 0.11	-2.83 log10 copies/mL Standard Error 0.11	-2.82 log10 copies/mL Standard Error 0.12	-2.72 log10 copies/mL Standard Error 0.11	-2.52 log10 copies/mL Standard Error 0.11	-2.73 log10 copies/mL Standard Error 0.11	—

SECONDARY outcome

Timeframe: Day 1 to Day 5

Outcome measures

Outcome measures
Measure	Pooled Placebo (IV + SC) n=128 Participants Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987	300mg IV n=131 Participants Participants received a single 300mg intravenous dose of REGN10933+REGN10987	600mg IV n=115 Participants Participants received a single 600mg intravenous dose of REGN10933+REGN10987	1200mg IV n=124 Participants Participants received a single 1200mg intravenous dose of REGN10933+REGN10987	2400mg IV n=132 Participants Participants received a single 2400mg intravenous dose of REGN10933+REGN10987	600mg SC n=128 Participants Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987	1200mg SC n=126 Participants Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987	1200mg SC Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
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	-1.69 log10 copies/mL Standard Error 0.08	-1.73 log10 copies/mL Standard Error 0.09	-1.76 log10 copies/mL Standard Error 0.09	-1.68 log10 copies/mL Standard Error 0.08	-1.62 log10 copies/mL Standard Error 0.08	-1.61 log10 copies/mL Standard Error 0.08	—
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	-1.77 log10 copies/mL Standard Error 0.08	-1.83 log10 copies/mL Standard Error 0.09	-1.81 log10 copies/mL Standard Error 0.09	-1.76 log10 copies/mL Standard Error 0.09	-1.69 log10 copies/mL Standard Error 0.08	-1.69 log10 copies/mL Standard Error 0.09	—
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	-1.89 log10 copies/mL Standard Error 0.09	-1.92 log10 copies/mL Standard Error 0.09	-1.93 log10 copies/mL Standard Error 0.09	-1.91 log10 copies/mL Standard Error 0.09	-1.76 log10 copies/mL Standard Error 0.09	-1.79 log10 copies/mL Standard Error 0.09	—
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	-1.99 log10 copies/mL Standard Error 0.10	-2.08 log10 copies/mL Standard Error 0.10	-2.08 log10 copies/mL Standard Error 0.11	-2.01 log10 copies/mL Standard Error 0.10	-1.76 log10 copies/mL Standard Error 0.10	-1.97 log10 copies/mL Standard Error 0.10	—

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Pooled Placebo (IV + SC) n=109 Participants Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987	300mg IV n=108 Participants Participants received a single 300mg intravenous dose of REGN10933+REGN10987	600mg IV n=100 Participants Participants received a single 600mg intravenous dose of REGN10933+REGN10987	1200mg IV n=97 Participants Participants received a single 1200mg intravenous dose of REGN10933+REGN10987	2400mg IV n=93 Participants Participants received a single 2400mg intravenous dose of REGN10933+REGN10987	600mg SC n=103 Participants Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987	1200mg SC n=111 Participants Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987	1200mg SC Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
Number of Participants With High Viral Load Day 1 Viral Load >10^4 copies/mL	108 Participants	106 Participants	96 Participants	95 Participants	91 Participants	99 Participants	106 Participants	—
Number of Participants With High Viral Load Day 1 Viral Load >10^5 copies/mL	104 Participants	99 Participants	92 Participants	89 Participants	84 Participants	93 Participants	95 Participants	—
Number of Participants With High Viral Load Day 1 Viral Load >10^6 copies/mL	88 Participants	83 Participants	86 Participants	76 Participants	78 Participants	81 Participants	88 Participants	—
Number of Participants With High Viral Load Day 1 Viral Load >10^7 copies/mL	60 Participants	67 Participants	64 Participants	54 Participants	58 Participants	63 Participants	62 Participants	—
Number of Participants With High Viral Load Day 3 Viral Load >10^4 copies/mL	93 Participants	92 Participants	79 Participants	80 Participants	80 Participants	89 Participants	89 Participants	—
Number of Participants With High Viral Load Day 3 Viral Load >10^5 copies/mL	83 Participants	68 Participants	63 Participants	67 Participants	61 Participants	68 Participants	75 Participants	—
Number of Participants With High Viral Load Day 3 Viral Load >10^6 copies/mL	59 Participants	47 Participants	43 Participants	36 Participants	39 Participants	41 Participants	53 Participants	—
Number of Participants With High Viral Load Day 3 Viral Load >10^7 copies/mL	29 Participants	15 Participants	15 Participants	14 Participants	14 Participants	25 Participants	23 Participants	—
Number of Participants With High Viral Load Day 5 Viral Load >10^4 copies/mL	78 Participants	65 Participants	58 Participants	58 Participants	55 Participants	62 Participants	67 Participants	—
Number of Participants With High Viral Load Day 5 Viral Load >10^5 copies/mL	53 Participants	31 Participants	20 Participants	30 Participants	29 Participants	29 Participants	31 Participants	—
Number of Participants With High Viral Load Day 5 Viral Load >10^6 copies/mL	29 Participants	7 Participants	9 Participants	3 Participants	10 Participants	7 Participants	9 Participants	—
Number of Participants With High Viral Load Day 5 Viral Load >10^7 copies/mL	14 Participants	0 Participants	3 Participants	0 Participants	0 Participants	5 Participants	2 Participants	—
Number of Participants With High Viral Load Day 7 Viral Load >10^4 copies/mL	59 Participants	32 Participants	35 Participants	27 Participants	28 Participants	33 Participants	35 Participants	—
Number of Participants With High Viral Load Day 7 Viral Load >10^5 copies/mL	32 Participants	9 Participants	9 Participants	7 Participants	13 Participants	9 Participants	9 Participants	—
Number of Participants With High Viral Load Day 7 Viral Load >10^6 copies/mL	13 Participants	2 Participants	1 Participants	0 Participants	0 Participants	2 Participants	1 Participants	—
Number of Participants With High Viral Load Day 7 Viral Load >10^7 copies/mL	5 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—
Number of Participants With High Viral Load Day 15 Viral Load >10^4 copies/mL	8 Participants	3 Participants	6 Participants	7 Participants	7 Participants	4 Participants	4 Participants	—
Number of Participants With High Viral Load Day 15 Viral Load >10^5 copies/mL	4 Participants	1 Participants	2 Participants	3 Participants	1 Participants	1 Participants	0 Participants	—
Number of Participants With High Viral Load Day 15 Viral Load >10^6 copies/mL	1 Participants	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	—
Number of Participants With High Viral Load Day 15 Viral Load >10^7 copies/mL	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With High Viral Load Day 22 Viral Load >10^4 copies/mL	3 Participants	0 Participants	3 Participants	0 Participants	4 Participants	1 Participants	3 Participants	—
Number of Participants With High Viral Load Day 22 Viral Load >10^5 copies/mL	2 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	—
Number of Participants With High Viral Load Day 22 Viral Load >10^6 copies/mL	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	—
Number of Participants With High Viral Load Day 22 Viral Load >10^7 copies/mL	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Pooled Placebo (IV + SC) n=109 Participants Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987	300mg IV n=108 Participants Participants received a single 300mg intravenous dose of REGN10933+REGN10987	600mg IV n=100 Participants Participants received a single 600mg intravenous dose of REGN10933+REGN10987	1200mg IV n=97 Participants Participants received a single 1200mg intravenous dose of REGN10933+REGN10987	2400mg IV n=93 Participants Participants received a single 2400mg intravenous dose of REGN10933+REGN10987	600mg SC n=103 Participants Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987	1200mg SC n=111 Participants Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987	1200mg SC Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
Number of Participants With Viral Loads Below the Limit of Detection Day 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With Viral Loads Below the Limit of Detection Day 3	3 Participants	1 Participants	4 Participants	3 Participants	1 Participants	1 Participants	5 Participants	—
Number of Participants With Viral Loads Below the Limit of Detection Day 5	6 Participants	11 Participants	10 Participants	12 Participants	12 Participants	11 Participants	12 Participants	—
Number of Participants With Viral Loads Below the Limit of Detection Day 7	19 Participants	22 Participants	16 Participants	14 Participants	18 Participants	25 Participants	19 Participants	—
Number of Participants With Viral Loads Below the Limit of Detection Day 15	55 Participants	68 Participants	58 Participants	54 Participants	50 Participants	67 Participants	65 Participants	—
Number of Participants With Viral Loads Below the Limit of Detection Day 22	73 Participants	78 Participants	74 Participants	70 Participants	62 Participants	81 Participants	84 Participants	—

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Pooled Placebo (IV + SC) n=109 Participants Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987	300mg IV n=108 Participants Participants received a single 300mg intravenous dose of REGN10933+REGN10987	600mg IV n=100 Participants Participants received a single 600mg intravenous dose of REGN10933+REGN10987	1200mg IV n=97 Participants Participants received a single 1200mg intravenous dose of REGN10933+REGN10987	2400mg IV n=93 Participants Participants received a single 2400mg intravenous dose of REGN10933+REGN10987	600mg SC n=103 Participants Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987	1200mg SC n=111 Participants Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987	1200mg SC Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
Number of Participants With Viral Loads Below the Lower Limit of Quantification Day 1	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	3 Participants	0 Participants	—
Number of Participants With Viral Loads Below the Lower Limit of Quantification Day 3	4 Participants	5 Participants	4 Participants	6 Participants	2 Participants	1 Participants	7 Participants	—
Number of Participants With Viral Loads Below the Lower Limit of Quantification Day 5	8 Participants	17 Participants	14 Participants	20 Participants	14 Participants	15 Participants	14 Participants	—
Number of Participants With Viral Loads Below the Lower Limit of Quantification Day 7	25 Participants	33 Participants	24 Participants	26 Participants	24 Participants	38 Participants	27 Participants	—
Number of Participants With Viral Loads Below the Lower Limit of Quantification Day 15	69 Participants	78 Participants	69 Participants	67 Participants	62 Participants	76 Participants	83 Participants	—
Number of Participants With Viral Loads Below the Lower Limit of Quantification Day 22	84 Participants	87 Participants	83 Participants	81 Participants	74 Participants	87 Participants	95 Participants	—

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure	Pooled Placebo (IV + SC) n=109 Participants Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987	300mg IV n=108 Participants Participants received a single 300mg intravenous dose of REGN10933+REGN10987	600mg IV n=100 Participants Participants received a single 600mg intravenous dose of REGN10933+REGN10987	1200mg IV n=97 Participants Participants received a single 1200mg intravenous dose of REGN10933+REGN10987	2400mg IV n=93 Participants Participants received a single 2400mg intravenous dose of REGN10933+REGN10987	600mg SC n=103 Participants Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987	1200mg SC n=111 Participants Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987	1200mg SC Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
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	-1.71 log10 copies/mL Standard Error 0.13	-1.91 log10 copies/mL Standard Error 0.14	-1.85 log10 copies/mL Standard Error 0.14	-1.69 log10 copies/mL Standard Error 0.14	-1.55 log10 copies/mL Standard Error 0.13	-1.65 log10 copies/mL Standard Error 0.13	—
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	-3.24 log10 copies/mL Standard Error 0.16	-3.37 log10 copies/mL Standard Error 0.16	-3.32 log10 copies/mL Standard Error 0.17	-3.33 log10 copies/mL Standard Error 0.17	-3.19 log10 copies/mL Standard Error 0.16	-3.20 log10 copies/mL Standard Error 0.16	—
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	-4.24 log10 copies/mL Standard Error 0.16	-4.08 log10 copies/mL Standard Error 0.16	-4.10 log10 copies/mL Standard Error 0.17	-4.17 log10 copies/mL Standard Error 0.17	-4.33 log10 copies/mL Standard Error 0.16	-4.04 log10 copies/mL Standard Error 0.16	—
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	-6.11 log10 copies/mL Standard Error 0.16	-5.97 log10 copies/mL Standard Error 0.17	-5.91 log10 copies/mL Standard Error 0.17	-5.77 log10 copies/mL Standard Error 0.17	-6.17 log10 copies/mL Standard Error 0.17	-6.05 log10 copies/mL Standard Error 0.16	—
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	-6.58 log10 copies/mL Standard Error 0.14	-6.50 log10 copies/mL Standard Error 0.14	-6.56 log10 copies/mL Standard Error 0.14	-6.36 log10 copies/mL Standard Error 0.15	-6.69 log10 copies/mL Standard Error 0.14	-6.60 log10 copies/mL Standard Error 0.13	—

SECONDARY outcome

Timeframe: Through day 29

Population: Safety Analysis Set (SAF): Randomized participants who received any study drug; based on the treatment received (as treated)

Outcome measures

Outcome measures
Measure	Pooled Placebo (IV + SC) n=82 Participants Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987	300mg IV n=165 Participants Participants received a single 300mg intravenous dose of REGN10933+REGN10987	600mg IV n=162 Participants Participants received a single 600mg intravenous dose of REGN10933+REGN10987	1200mg IV n=165 Participants Participants received a single 1200mg intravenous dose of REGN10933+REGN10987	2400mg IV n=166 Participants Participants received a single 2400mg intravenous dose of REGN10933+REGN10987	600mg SC n=82 Participants Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987	1200mg SC n=163 Participants Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987	1200mg SC n=164 Participants Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs)	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Through day 4

Population: Safety Analysis Set (SAF): Randomized participants who received any study drug; based on the treatment received (as treated)

Outcome measures

Outcome measures
Measure	Pooled Placebo (IV + SC) n=82 Participants Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987	300mg IV n=165 Participants Participants received a single 300mg intravenous dose of REGN10933+REGN10987	600mg IV n=162 Participants Participants received a single 600mg intravenous dose of REGN10933+REGN10987	1200mg IV n=165 Participants Participants received a single 1200mg intravenous dose of REGN10933+REGN10987	2400mg IV n=166 Participants Participants received a single 2400mg intravenous dose of REGN10933+REGN10987	600mg SC n=82 Participants Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987	1200mg SC n=163 Participants Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987	1200mg SC n=164 Participants Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
Number of Participants With Infusion-Related Reactions Grade 2 or Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Through day 4

Population: Safety Analysis Set (SAF): Randomized participants who received any study drug; based on the treatment received (as treated)

Outcome measures

Outcome measures
Measure	Pooled Placebo (IV + SC) n=82 Participants Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987	300mg IV n=165 Participants Participants received a single 300mg intravenous dose of REGN10933+REGN10987	600mg IV n=162 Participants Participants received a single 600mg intravenous dose of REGN10933+REGN10987	1200mg IV n=165 Participants Participants received a single 1200mg intravenous dose of REGN10933+REGN10987	2400mg IV n=166 Participants Participants received a single 2400mg intravenous dose of REGN10933+REGN10987	600mg SC n=82 Participants Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987	1200mg SC n=163 Participants Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987	1200mg SC n=164 Participants Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
Number of Participants With Injection-Site Reactions Grade 3 or Above	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Through day 29

Population: Safety Analysis Set (SAF): Randomized participants who received any study drug; based on the treatment received (as treated)

Outcome measures

Outcome measures
Measure	Pooled Placebo (IV + SC) n=82 Participants Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987	300mg IV n=165 Participants Participants received a single 300mg intravenous dose of REGN10933+REGN10987	600mg IV n=162 Participants Participants received a single 600mg intravenous dose of REGN10933+REGN10987	1200mg IV n=165 Participants Participants received a single 1200mg intravenous dose of REGN10933+REGN10987	2400mg IV n=166 Participants Participants received a single 2400mg intravenous dose of REGN10933+REGN10987	600mg SC n=82 Participants Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987	1200mg SC n=163 Participants Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987	1200mg SC n=164 Participants Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
Number of Participants With Hypersensitivity Reactions Grade 2 or Above	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Pooled Placebo (IV + SC) n=165 Participants Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987	300mg IV n=162 Participants Participants received a single 300mg intravenous dose of REGN10933+REGN10987	600mg IV n=165 Participants Participants received a single 600mg intravenous dose of REGN10933+REGN10987	1200mg IV n=166 Participants Participants received a single 1200mg intravenous dose of REGN10933+REGN10987	2400mg IV n=163 Participants Participants received a single 2400mg intravenous dose of REGN10933+REGN10987	600mg SC n=164 Participants Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987	1200mg SC Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987	1200mg SC Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
Concentration of REGN10933 in Serum Pre-dose	0.529 milligrams per liter (mg/L) Standard Deviation 4.51	1.95 milligrams per liter (mg/L) Standard Deviation 12.1	0.847 milligrams per liter (mg/L) Standard Deviation 6.28	13.3 milligrams per liter (mg/L) Standard Deviation 130	0.992 milligrams per liter (mg/L) Standard Deviation 12.5	0.395 milligrams per liter (mg/L) Standard Deviation 4.96	—	—
Concentration of REGN10933 in Serum 15 minutes Post-Dose	58.2 milligrams per liter (mg/L) Standard Deviation 52.1	95.8 milligrams per liter (mg/L) Standard Deviation 57.9	178 milligrams per liter (mg/L) Standard Deviation 118	375 milligrams per liter (mg/L) Standard Deviation 267	8.73 milligrams per liter (mg/L) Standard Deviation 52.7	3.89 milligrams per liter (mg/L) Standard Deviation 19.7	—	—
Concentration of REGN10933 in Serum 3 days Post-Dose	32.5 milligrams per liter (mg/L) Standard Deviation 15.7	54.9 milligrams per liter (mg/L) Standard Deviation 19.2	109 milligrams per liter (mg/L) Standard Deviation 37.9	223 milligrams per liter (mg/L) Standard Deviation 63.9	22.4 milligrams per liter (mg/L) Standard Deviation 18.3	41.0 milligrams per liter (mg/L) Standard Deviation 19.3	—	—
Concentration of REGN10933 in Serum 5 days Post-Dose	27.7 milligrams per liter (mg/L) Standard Deviation 16.8	46.6 milligrams per liter (mg/L) Standard Deviation 16.9	88.4 milligrams per liter (mg/L) Standard Deviation 27.8	186 milligrams per liter (mg/L) Standard Deviation 53.3	26.3 milligrams per liter (mg/L) Standard Deviation 10.7	54.9 milligrams per liter (mg/L) Standard Deviation 34.0	—	—
Concentration of REGN10933 in Serum 7 days Post-Dose	23.9 milligrams per liter (mg/L) Standard Deviation 13.5	39.8 milligrams per liter (mg/L) Standard Deviation 11.5	82.8 milligrams per liter (mg/L) Standard Deviation 26.3	164 milligrams per liter (mg/L) Standard Deviation 46.0	26.8 milligrams per liter (mg/L) Standard Deviation 9.65	54.6 milligrams per liter (mg/L) Standard Deviation 19.9	—	—
Concentration of REGN10933 in Serum 120 days Post-Dose	1.78 milligrams per liter (mg/L) Standard Deviation 1.13	3.25 milligrams per liter (mg/L) Standard Deviation 1.88	6.46 milligrams per liter (mg/L) Standard Deviation 4.74	12.3 milligrams per liter (mg/L) Standard Deviation 8.42	2.73 milligrams per liter (mg/L) Standard Deviation 1.89	5.64 milligrams per liter (mg/L) Standard Deviation 3.77	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Pooled Placebo (IV + SC) n=149 Participants Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987	300mg IV n=152 Participants Participants received a single 300mg intravenous dose of REGN10933+REGN10987	600mg IV n=138 Participants Participants received a single 600mg intravenous dose of REGN10933+REGN10987	1200mg IV n=150 Participants Participants received a single 1200mg intravenous dose of REGN10933+REGN10987	2400mg IV n=150 Participants Participants received a single 2400mg intravenous dose of REGN10933+REGN10987	600mg SC n=147 Participants Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987	1200mg SC n=141 Participants Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987	1200mg SC Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 Pre-existing Immunoreactivity	3 Participants	2 Participants	3 Participants	0 Participants	2 Participants	1 Participants	3 Participants	—
Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 Treatment-Boosted Response	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 Treatment-Emergent Response	4 Participants	11 Participants	6 Participants	7 Participants	1 Participants	14 Participants	5 Participants	—
Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10933 Negative	142 Participants	139 Participants	128 Participants	143 Participants	147 Participants	132 Participants	133 Participants	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Pooled Placebo (IV + SC) n=148 Participants Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987	300mg IV n=152 Participants Participants received a single 300mg intravenous dose of REGN10933+REGN10987	600mg IV n=138 Participants Participants received a single 600mg intravenous dose of REGN10933+REGN10987	1200mg IV n=150 Participants Participants received a single 1200mg intravenous dose of REGN10933+REGN10987	2400mg IV n=150 Participants Participants received a single 2400mg intravenous dose of REGN10933+REGN10987	600mg SC n=147 Participants Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987	1200mg SC n=141 Participants Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987	1200mg SC Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933 Treatment-emergent & Treatment-boosted; Negative in NAb assay	4 Participants	11 Participants	7 Participants	6 Participants	0 Participants	13 Participants	5 Participants	—
Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933 Treatment-emergent & Treatment-boosted; Positive in NAb assay	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	—
Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10933 ADA Negative	142 Participants	139 Participants	128 Participants	143 Participants	147 Participants	132 Participants	133 Participants	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Pooled Placebo (IV + SC) n=165 Participants Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987	300mg IV n=162 Participants Participants received a single 300mg intravenous dose of REGN10933+REGN10987	600mg IV n=165 Participants Participants received a single 600mg intravenous dose of REGN10933+REGN10987	1200mg IV n=166 Participants Participants received a single 1200mg intravenous dose of REGN10933+REGN10987	2400mg IV n=163 Participants Participants received a single 2400mg intravenous dose of REGN10933+REGN10987	600mg SC n=164 Participants Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987	1200mg SC Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987	1200mg SC Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
Concentration of REGN10987 in Serum Pre-dose	0.529 milligrams per liter (mg/L) Standard Deviation 4.38	2.04 milligrams per liter (mg/L) Standard Deviation 12.7	0.823 milligrams per liter (mg/L) Standard Deviation 6.48	13.1 milligrams per liter (mg/L) Standard Deviation 126	1.02 milligrams per liter (mg/L) Standard Deviation 12.8	0.370 milligrams per liter (mg/L) Standard Deviation 4.64	—	—
Concentration of REGN10987 in Serum 15 minutes Post-Dose	56.9 milligrams per liter (mg/L) Standard Deviation 53.1	95.4 milligrams per liter (mg/L) Standard Deviation 59.4	178 milligrams per liter (mg/L) Standard Deviation 119	383 milligrams per liter (mg/L) Standard Deviation 273	8.48 milligrams per liter (mg/L) Standard Deviation 51.7	4.36 milligrams per liter (mg/L) Standard Deviation 21.6	—	—
Concentration of REGN10987 in Serum 3 days Post-Dose	32.6 milligrams per liter (mg/L) Standard Deviation 15.9	56.0 milligrams per liter (mg/L) Standard Deviation 18.9	109 milligrams per liter (mg/L) Standard Deviation 38.5	225 milligrams per liter (mg/L) Standard Deviation 62.3	21.8 milligrams per liter (mg/L) Standard Deviation 16.2	42.0 milligrams per liter (mg/L) Standard Deviation 20.1	—	—
Concentration of REGN10987 in Serum 5 days Post-Dose	26.6 milligrams per liter (mg/L) Standard Deviation 15.5	46.3 milligrams per liter (mg/L) Standard Deviation 15.9	87.1 milligrams per liter (mg/L) Standard Deviation 26.9	177 milligrams per liter (mg/L) Standard Deviation 50.9	25.6 milligrams per liter (mg/L) Standard Deviation 9.31	52.9 milligrams per liter (mg/L) Standard Deviation 29.1	—	—
Concentration of REGN10987 in Serum 7 days Post-Dose	22.8 milligrams per liter (mg/L) Standard Deviation 12.8	38.0 milligrams per liter (mg/L) Standard Deviation 11.2	77.7 milligrams per liter (mg/L) Standard Deviation 24.3	151 milligrams per liter (mg/L) Standard Deviation 43.1	26.2 milligrams per liter (mg/L) Standard Deviation 8.74	53.7 milligrams per liter (mg/L) Standard Deviation 17.9	—	—
Concentration of REGN10987 in Serum 120 days Post-Dose	1.02 milligrams per liter (mg/L) Standard Deviation 0.805	1.97 milligrams per liter (mg/L) Standard Deviation 1.38	3.80 milligrams per liter (mg/L) Standard Deviation 3.10	6.88 milligrams per liter (mg/L) Standard Deviation 5.47	1.63 milligrams per liter (mg/L) Standard Deviation 1.43	3.26 milligrams per liter (mg/L) Standard Deviation 2.49	—	—

SECONDARY outcome

Timeframe: Through day 120

Outcome measures

Outcome measures
Measure	Pooled Placebo (IV + SC) n=149 Participants Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987	300mg IV n=152 Participants Participants received a single 300mg intravenous dose of REGN10933+REGN10987	600mg IV n=138 Participants Participants received a single 600mg intravenous dose of REGN10933+REGN10987	1200mg IV n=150 Participants Participants received a single 1200mg intravenous dose of REGN10933+REGN10987	2400mg IV n=150 Participants Participants received a single 2400mg intravenous dose of REGN10933+REGN10987	600mg SC n=147 Participants Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987	1200mg SC n=141 Participants Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987	1200mg SC Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 Pre-existing Immunoreactivity	3 Participants	4 Participants	0 Participants	3 Participants	3 Participants	3 Participants	3 Participants	—
Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 Treatment-Boosted Response	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—
Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 Treatment-Emergent Response	6 Participants	17 Participants	11 Participants	13 Participants	7 Participants	23 Participants	14 Participants	—
Immunogenicity as Measured by Anti-drug Antibodies (ADAs) to REGN10987 Negative	142 Participants	131 Participants	126 Participants	133 Participants	140 Participants	121 Participants	124 Participants	—

SECONDARY outcome

Timeframe: Through day 120

Outcome measures

Outcome measures
Measure	Pooled Placebo (IV + SC) n=148 Participants Participants received a single intravenous dose of placebo matching REGN10933+REGN10987 or a single subcutaneous dose of placebo matching REGN10933+REGN10987	300mg IV n=152 Participants Participants received a single 300mg intravenous dose of REGN10933+REGN10987	600mg IV n=138 Participants Participants received a single 600mg intravenous dose of REGN10933+REGN10987	1200mg IV n=150 Participants Participants received a single 1200mg intravenous dose of REGN10933+REGN10987	2400mg IV n=150 Participants Participants received a single 2400mg intravenous dose of REGN10933+REGN10987	600mg SC n=147 Participants Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987	1200mg SC n=141 Participants Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987	1200mg SC Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 Pre-existing Immunoreactivity; Negative in NAb assay	1 Participants	2 Participants	0 Participants	2 Participants	1 Participants	2 Participants	3 Participants	—
Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 Treatment-emergent & Treatment-boosted; Negative in NAb assay	5 Participants	10 Participants	7 Participants	10 Participants	5 Participants	17 Participants	10 Participants	—
Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 Treatment-emergent & Treatment-boosted; Positive in NAb assay	1 Participants	7 Participants	5 Participants	4 Participants	2 Participants	6 Participants	4 Participants	—
Immunogenicity as Measured by Neutralizing Anti-drug Antibody (NAb) to REGN10987 ADA Negative	140 Participants	131 Participants	126 Participants	133 Participants	140 Participants	121 Participants	124 Participants	—

Adverse Events

Placebo IV

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

REGN10933 + REGN10987 300 mg IV

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

REGN10933 + REGN10987 600 mg IV

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

REGN10933 + REGN10987 1200 mg IV

Serious events: 1 serious events

Other events: 28 other events

Deaths: 0 deaths

REGN10933 + REGN10987 2400 mg IV

Serious events: 3 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo SC

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

REGN10933 + REGN10987 600 mg SC

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

REGN10933 + REGN10987 1200 mg SC

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo IV n=82 participants at risk Participants received a single intravenous dose of placebo matching REGN10933+REGN10987	REGN10933 + REGN10987 300 mg IV n=165 participants at risk Participants received a single 300mg intravenous dose of REGN10933+REGN10987	REGN10933 + REGN10987 600 mg IV n=162 participants at risk Participants received a single 600mg intravenous dose of REGN10933+REGN10987	REGN10933 + REGN10987 1200 mg IV n=165 participants at risk Participants received a single 1200mg intravenous dose of REGN10933+REGN10987	REGN10933 + REGN10987 2400 mg IV n=166 participants at risk Participants received a single 2400mg intravenous dose of REGN10933+REGN10987	Placebo SC n=82 participants at risk Participants received a single subcutaneous dose of placebo matching REGN10933+REGN10987	REGN10933 + REGN10987 600 mg SC n=163 participants at risk Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987	REGN10933 + REGN10987 1200 mg SC n=164 participants at risk Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/82 • From first dose of study drug to Day 169	0.00% 0/165 • From first dose of study drug to Day 169	0.00% 0/162 • From first dose of study drug to Day 169	0.61% 1/165 • Number of events 1 • From first dose of study drug to Day 169	0.60% 1/166 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/82 • From first dose of study drug to Day 169	0.00% 0/163 • From first dose of study drug to Day 169	0.00% 0/164 • From first dose of study drug to Day 169
Injury, poisoning and procedural complications Face injury	0.00% 0/82 • From first dose of study drug to Day 169	0.61% 1/165 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/162 • From first dose of study drug to Day 169	0.00% 0/165 • From first dose of study drug to Day 169	0.00% 0/166 • From first dose of study drug to Day 169	0.00% 0/82 • From first dose of study drug to Day 169	0.00% 0/163 • From first dose of study drug to Day 169	0.00% 0/164 • From first dose of study drug to Day 169
Injury, poisoning and procedural complications Abdominal injury	0.00% 0/82 • From first dose of study drug to Day 169	0.00% 0/165 • From first dose of study drug to Day 169	0.00% 0/162 • From first dose of study drug to Day 169	0.00% 0/165 • From first dose of study drug to Day 169	0.60% 1/166 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/82 • From first dose of study drug to Day 169	0.00% 0/163 • From first dose of study drug to Day 169	0.00% 0/164 • From first dose of study drug to Day 169
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/82 • From first dose of study drug to Day 169	0.00% 0/165 • From first dose of study drug to Day 169	0.00% 0/162 • From first dose of study drug to Day 169	0.00% 0/165 • From first dose of study drug to Day 169	0.60% 1/166 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/82 • From first dose of study drug to Day 169	0.00% 0/163 • From first dose of study drug to Day 169	0.00% 0/164 • From first dose of study drug to Day 169
Infections and infestations COVID-19 pneumonia	0.00% 0/82 • From first dose of study drug to Day 169	0.00% 0/165 • From first dose of study drug to Day 169	0.00% 0/162 • From first dose of study drug to Day 169	0.00% 0/165 • From first dose of study drug to Day 169	0.00% 0/166 • From first dose of study drug to Day 169	0.00% 0/82 • From first dose of study drug to Day 169	0.00% 0/163 • From first dose of study drug to Day 169	0.61% 1/164 • Number of events 1 • From first dose of study drug to Day 169
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/82 • From first dose of study drug to Day 169	0.00% 0/165 • From first dose of study drug to Day 169	0.00% 0/162 • From first dose of study drug to Day 169	0.00% 0/165 • From first dose of study drug to Day 169	0.60% 1/166 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/82 • From first dose of study drug to Day 169	0.00% 0/163 • From first dose of study drug to Day 169	0.00% 0/164 • From first dose of study drug to Day 169
Psychiatric disorders Mental status changes	1.2% 1/82 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/165 • From first dose of study drug to Day 169	0.00% 0/162 • From first dose of study drug to Day 169	0.00% 0/165 • From first dose of study drug to Day 169	0.00% 0/166 • From first dose of study drug to Day 169	0.00% 0/82 • From first dose of study drug to Day 169	0.00% 0/163 • From first dose of study drug to Day 169	0.00% 0/164 • From first dose of study drug to Day 169
Renal and urinary disorders Urinary bladder rupture	0.00% 0/82 • From first dose of study drug to Day 169	0.00% 0/165 • From first dose of study drug to Day 169	0.00% 0/162 • From first dose of study drug to Day 169	0.00% 0/165 • From first dose of study drug to Day 169	0.60% 1/166 • Number of events 1 • From first dose of study drug to Day 169	0.00% 0/82 • From first dose of study drug to Day 169	0.00% 0/163 • From first dose of study drug to Day 169	0.00% 0/164 • From first dose of study drug to Day 169

Other adverse events

Other adverse events
Measure	Placebo IV n=82 participants at risk Participants received a single intravenous dose of placebo matching REGN10933+REGN10987	REGN10933 + REGN10987 300 mg IV n=165 participants at risk Participants received a single 300mg intravenous dose of REGN10933+REGN10987	REGN10933 + REGN10987 600 mg IV n=162 participants at risk Participants received a single 600mg intravenous dose of REGN10933+REGN10987	REGN10933 + REGN10987 1200 mg IV n=165 participants at risk Participants received a single 1200mg intravenous dose of REGN10933+REGN10987	REGN10933 + REGN10987 2400 mg IV n=166 participants at risk Participants received a single 2400mg intravenous dose of REGN10933+REGN10987	Placebo SC n=82 participants at risk Participants received a single subcutaneous dose of placebo matching REGN10933+REGN10987	REGN10933 + REGN10987 600 mg SC n=163 participants at risk Participants received a single 600mg subcutaneous dose of REGN10933+REGN10987	REGN10933 + REGN10987 1200 mg SC n=164 participants at risk Participants received a single 1200mg subcutaneous dose of REGN10933+REGN10987
Infections and infestations COVID-19	20.7% 17/82 • Number of events 18 • From first dose of study drug to Day 169	12.7% 21/165 • Number of events 21 • From first dose of study drug to Day 169	16.7% 27/162 • Number of events 28 • From first dose of study drug to Day 169	17.0% 28/165 • Number of events 29 • From first dose of study drug to Day 169	9.6% 16/166 • Number of events 18 • From first dose of study drug to Day 169	13.4% 11/82 • Number of events 11 • From first dose of study drug to Day 169	11.0% 18/163 • Number of events 19 • From first dose of study drug to Day 169	12.8% 21/164 • Number of events 21 • From first dose of study drug to Day 169

Additional Information

Clinical Trials Administrator

Regeneron Pharmaceuticals, Inc.

Phone: 844-734-6643

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
Publication restrictions are in place

Restriction type: OTHER