NCT04452318 is a Phase 3 clinical trial of REGN10933 + REGN10987 in Healthy Participants, sponsored by Regeneron Pharmaceuticals.

Who is sponsoring NCT04452318?

NCT04452318 is sponsored by Regeneron Pharmaceuticals.

What drugs are being tested in NCT04452318?

Interventions in NCT04452318: REGN10933 + REGN10987, Placebo.

What condition does NCT04452318 study?

NCT04452318 studies Healthy Participants.

Is NCT04452318 still recruiting?

NCT04452318 is currently completed. Last updated 15 May 2023.

Are results published for NCT04452318?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-05-15 · How we verify

NCT04452318

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

COVID-19 Study Assessing the Efficacy and Safety of Anti-Spike SARS CoV-2 Monoclonal Antibodies for Prevention of SARS CoV-2 Infection Asymptomatic in Healthy Adults and Adolescents Who Are Household Contacts to an Individual With a Positive SARS-CoV-2 RT-PCR Assay

Completed Phase 3 Results posted Last updated 15 May 2023

What this trial tests

Phase 3 trial testing REGN10933 + REGN10987 in Healthy Participants in 3,303 participants. Completed in 4 October 2021.

Timeline

13 July 2020

Primary endpoint
4 October 2021

4 October 2021

Quick facts

Lead sponsor	Regeneron Pharmaceuticals
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	3,303
Start date	13 July 2020
Primary completion	4 October 2021
Estimated completion	4 October 2021
Sites	134 locations across Romania, United States, Moldova

Drugs / interventions tested

REGN10933 + REGN10987 — full drug profile →
Placebo

Conditions studied

Healthy Participants — all drugs for Healthy Participants →

Sponsor

Regeneron Pharmaceuticals — full company profile →

Who can join

1 Day and older, any sex, with Healthy Participants. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) During the EAP Primary · Up to 1 month

Symptomatic SARS-CoV-2 infection (broad-term) is defined as a positive central lab SARS-CoV-2 RT-qPCR result (either NP, nasal or saliva) associated with signs and symptoms with the onset date occurring within 14 days of a positive RT-qPCR during the EAP. Percentage estimated by Logistic Regression.

Group	Value	95% CI
Cohort A: Placebo of R10933 + R10987	7.8
Cohort A: R10933 + R10987	1.4

Cohort B: Percentage of Participants Who Subsequently Develop Signs and Symptoms (Broad-Term) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP Primary · Up to 14 Days

The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:\>=12 to=50), and region (US vs ex-US).

Group	Value	95% CI
Cohort B: Placebo of R10933 + R10987	42.5
Cohort B: R10933 + R10987	28.4

Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs Primary · Up to 8 months

# of participants with at least one TEAE

Group	Value	95% CI
Cohort A: Placebo of R10933 + R10987	512
Cohort A: R10933 + R10987	405
Cohort B: Placebo of R10933 + R10987	88
Cohort B: R10933 + R10987	60

# of participants with at least one Grade 1 TEAE

Group	Value	95% CI
Cohort A: Placebo of R10933 + R10987	384
Cohort A: R10933 + R10987	284
Cohort B: Placebo of R10933 + R10987	61
Cohort B: R10933 + R10987	51

# of participants with at least one Grade 2 TEAE

Group	Value	95% CI
Cohort A: Placebo of R10933 + R10987	98
Cohort A: R10933 + R10987	95
Cohort B: Placebo of R10933 + R10987	21
Cohort B: R10933 + R10987	7

# of participants with at least one Grade 3 TEAE

Group	Value	95% CI
Cohort A: Placebo of R10933 + R10987	26
Cohort A: R10933 + R10987	21
Cohort B: Placebo of R10933 + R10987	6
Cohort B: R10933 + R10987	2

# of participants with at least one Grade 4 TEAE

Group	Value	95% CI
Cohort A: Placebo of R10933 + R10987	2
Cohort A: R10933 + R10987	2
Cohort B: Placebo of R10933 + R10987	0
Cohort B: R10933 + R10987	0

# of participants with at least one Grade 5 TEAE

Group	Value	95% CI
Cohort A: Placebo of R10933 + R10987	2
Cohort A: R10933 + R10987	3
Cohort B: Placebo of R10933 + R10987	0
Cohort B: R10933 + R10987	0

Cohort A and Cohort B: Percentage of Participants With High Viral Load in Nasopharyngeal (NP) Swab Samples During the EAP Secondary · Up to 1 month

High viral load (\> 4 log 10 copies/ml)

Group	Value	95% CI
Cohort A: Placebo of R10933 + R10987	11.3
Cohort A: R10933 + R10987	1.6
Cohort B: Placebo of R10933 + R10987	62.6
Cohort B: R10933 + R10987	40.5

Cohort A: Number of Weeks of Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad Term) During the EAP Secondary · Up to 1 month

Group	Value	95% CI
Cohort A: Placebo of R10933 + R10987	0.25	± 1.135
Cohort A: R10933 + R10987	0.02	± 0.181

Cohort A and Cohort B: Number of Weeks of High Viral Load in NP Swab Samples During the EAP Secondary · Up to 1 month

High viral load (\> 4 log 10 copies/ml)

Group	Value	95% CI
Cohort A: Placebo of R10933 + R10987	0.18	± 0.554
Cohort A: R10933 + R10987	0.02	± 0.154
Cohort B: Placebo of R10933 + R10987	0.81	± 0.758
Cohort B: R10933 + R10987	0.49	± 0.677

Cohort A: Number of Weeks of RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP Secondary · Up to 1 month

Group	Value	95% CI
Cohort A: Placebo of R10933 + R10987	0.31	± 0.854
Cohort A: R10933 + R10987	0.05	± 0.260

Cohort A: Percentage of Participants Who Have a RT-qPCR Confirmed SARS-CoV-2 Infection (Regardless of Symptoms) During the EAP Secondary · Up to 1 month

The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:\>=12 to=50), and region (US vs ex-US)

Group	Value	95% CI
Cohort A: Placebo of R10933 + R10987	14.56
Cohort A: R10933 + R10987	5.00

Cohort A: Percentage of Participants in Placebo Group With a RT-qPCR Confirmed SARS-CoV-2 Infection During the EAP With an Index Case Participating in Study R10933-10987-COV-2067 (NCT04425629) Secondary · Up to 1 month

% with index case receiving R10933+R10987 in 2067

Group	Value	95% CI
Cohort A: Placebo of R10933 + R10987	19.8

% with index case receiving placebo in 2067

Group	Value	95% CI
Cohort A: Placebo of R10933 + R10987	19.6

% with index case treatment in 2067 not available

Group	Value	95% CI
Cohort A: Placebo of R10933 + R10987	10.5

Cohort A: Percentage of Participants With a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (CDC Definition) During the EAP Secondary · Up to 1 month

Symptomatic SARS-CoV-2 infection (CDC definition) is defined as a positive central lab SARS-CoV-2 RT-qPCR result (either NP, nasal or saliva) associated with signs and symptoms with the onset date occurring within 14 days of a positive RT-qPCR during the EAP. Percentage estimated by Logistic Regression.

Group	Value	95% CI
Cohort A: Placebo of R10933 + R10987	5.9
Cohort A: R10933 + R10987	0.8

Cohort A: Number of Weeks of Symptomatic RT-qPCR-confirmed SARS-CoV-2 Infection (CDC Definition) During the EAP Secondary · Up to 1 month

Group	Value	95% CI
Cohort A: Placebo of R10933 + R10987	0.21	± 1.042
Cohort A: R10933 + R10987	0.01	± 0.128

Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Strict-term) During the EAP Secondary · Up to 1 month

The percentage of participants was estimated by using the logistic regression model with fixed categorical effects of treatment group, age group (age in years:\>=12 to=50), and region (US vs ex-US)

Group	Value	95% CI
Cohort A: Placebo of R10933 + R10987	2.8
Cohort A: R10933 + R10987	0.2

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to day 226. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort A Placebo

Serious: 23/1428 (2%)

Deaths: 2/1428

Cohort A R10933+R10987

Serious: 24/1439 (2%)

Deaths: 3/1439

Cohort A1 Placebo

Serious: 0/1 (0%)

Deaths: 0/1

Cohort B Placebo

Serious: 5/170 (3%)

Deaths: 0/170

Cohort B R10933+R10987

Serious: 1/165 (1%)

Deaths: 0/165

Undetermined Placebo

Serious: 0/44 (0%)

Deaths: 0/44

Undetermined R10933+R10987

Serious: 0/23 (0%)

Deaths: 0/23

Serious adverse events (47 terms)

Reaction	System	Cohort A Placebo	Cohort A R10933+R10987	Cohort A1 Placebo	Cohort B Placebo	Cohort B R10933+R10987	Undetermined Placebo	Undetermined R10933+R10987
COVID-19	Infections and infestations	—	—	—	—	—	—	—
COVID-19 pneumonia	Infections and infestations	—	—	—	—	—	—	—
Appendicitis	Infections and infestations	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—
Road traffic accident	Injury, poisoning and procedural complications	—	—	—	—	—	—	—
Suicidal ideation	Psychiatric disorders	—	—	—	—	—	—	—
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	—	—	—	—	—	—	—
Acute myocardial infarction	Cardiac disorders	—	—	—	—	—	—	—
Pyelonephritis	Infections and infestations	—	—	—	—	—	—	—
Scrotal abscess	Infections and infestations	—	—	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—	—	—
Abscess limb	Infections and infestations	—	—	—	—	—	—	—
Gangrene	Infections and infestations	—	—	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—	—	—
Osteomyelitis	Infections and infestations	—	—	—	—	—	—	—
Soft tissue infection	Infections and infestations	—	—	—	—	—	—	—
Gun shot wound	Injury, poisoning and procedural complications	—	—	—	—	—	—	—
Humerus fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—
Soft tissue injury	Injury, poisoning and procedural complications	—	—	—	—	—	—	—
Ankle fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—
Burns second degree	Injury, poisoning and procedural complications	—	—	—	—	—	—	—
Foot fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—
Post procedural complication	Injury, poisoning and procedural complications	—	—	—	—	—	—	—
Post procedural haemorrhage	Injury, poisoning and procedural complications	—	—	—	—	—	—	—
Post procedural inflammation	Injury, poisoning and procedural complications	—	—	—	—	—	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	Cohort A Placebo	Cohort A R10933+R10987	Cohort A1 Placebo	Cohort B Placebo	Cohort B R10933+R10987	Undetermined Placebo	Undetermined R10933+R10987
COVID-19	Infections and infestations	—	—	—	—	—	—	—
Asymptomatic COVID-19	Infections and infestations	—	—	—	—	—	—	—

Most-reported serious reactions: COVID-19, COVID-19 pneumonia, Appendicitis, Pneumonia, Road traffic accident, Suicidal ideation, Abortion spontaneous, Acute myocardial infarction.

Data from ClinicalTrials.gov NCT04452318 adverse events section.

Sponsor's own description

Primary Objectives: Cohort A: • To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing symptomatic SARS-CoV-2 infection (broad-term) confirmed by RT-qPCR Cohort A and Cohort A1: • To evaluate the safety and tolerability of REGN10933+REGN10987 following subcutaneous (SC) administration compared to placebo Cohort B • To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing COVID-19 symptoms (broad-term) Cohort B and Cohort B1 • To evaluate the safety and tolerability of REGN10933+REGN10987 following SC administration compared to placebo

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

REGN-COV2, a Neutralizing Antibody Cocktail, in Outpatients with Covid-19.
Weinreich DM, Sivapalasingam S, Norton T, Ali S, et al · · 2021 · cited 1382× · PMID 33332778 · DOI 10.1056/nejmoa2035002
Neutralizing monoclonal antibodies for treatment of COVID-19.
Taylor PC, Adams AC, Hufford MM, de la Torre I, et al · · 2021 · cited 604× · PMID 33875867 · DOI 10.1038/s41577-021-00542-x
REGN-COV2 antibodies prevent and treat SARS-CoV-2 infection in rhesus macaques and hamsters.
Baum A, Ajithdoss D, Copin R, Zhou A, et al · · 2020 · cited 481× · PMID 33037066 · DOI 10.1126/science.abe2402
Subcutaneous REGEN-COV Antibody Combination to Prevent Covid-19.
O'Brien MP, Forleo-Neto E, Musser BJ, Isa F, et al · · 2021 · cited 390× · PMID 34347950 · DOI 10.1056/nejmoa2109682
Tackling COVID-19 with neutralizing monoclonal antibodies.
Corti D, Purcell LA, Snell G, Veesler D. · · 2021 · cited 300× · PMID 34087172 · DOI 10.1016/j.cell.2021.05.005
Molecular mechanism of interaction between SARS-CoV-2 and host cells and interventional therapy.
Zhang Q, Xiang R, Huo S, Zhou Y, et al · · 2021 · cited 219× · PMID 34117216 · DOI 10.1038/s41392-021-00653-w
Antibodies to watch in 2021.
Kaplon H, Reichert JM. · · 2021 · cited 215× · PMID 33459118 · DOI 10.1080/19420862.2020.1860476
Extremely potent human monoclonal antibodies from COVID-19 convalescent patients.
Andreano E, Nicastri E, Paciello I, Pileri P, et al · · 2021 · cited 204× · PMID 33667349 · DOI 10.1016/j.cell.2021.02.035

Verify or expand the search:

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Other Regeneron Pharmaceuticals trials

Trials by the same sponsor.

NCT07428369 — A Study of Linvo-VR vs DVRd in Transplant-Eligible Adult Participants With Newly Diagnosed Multiple Myeloma (NDMM) · Phase 2, PHASE3 · not yet recruiting
NCT07526116 — A First in Human Study to Assess Safety, Tolerability and Pharmacokinetics of a Single Dose of REGN22044 in Healthy Adul · Phase 1 · not yet recruiting
NCT07527923 — First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis · Phase 1 · not yet recruiting
NCT07527910 — A Phase 2a Study of ALN-PNP With and Without a GLP1R Agonist in Adult Patients With Homozygous PNPLA3-Related MASLD · Phase 2 · not yet recruiting
NCT07477704 — A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemi · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04452318 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Regeneron Pharmaceuticals
Last refreshed: 15 May 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04452318.

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