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CompletedNCT04519437Updated Jan 26, 2022

Study Assessing the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Repeated Subcutaneous Doses of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (REGN10933+REGN10987) in Adult Volunteers as Related to COVID-19

A Phase 1 interventional study of REGN10933+REGN10987 and Placebo in Healthy and Chronic Stable Illness, sponsored by Regeneron Pharmaceuticals. Completed at 7 sites in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-26.

Sponsored by Regeneron Pharmaceuticals · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Nov 2021, 4 years 10 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
974
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

The primary objectives are:

  • To assess the occurrence of adverse events of special interest (AESIs) in participants treated with repeated subcutaneous (SC) doses of REGN10933+REGN10987 compared to placebo
  • To assess the concentrations of REGN10933 and REGN10987 in serum over time after single and repeated SC administration

The secondary objectives are:

  • To assess the safety and tolerability of repeated SC doses of REGN10933+REGN10987 compared to placebo
  • To assess attainment of target concentrations of REGN10933 and REGN10987 in serum after single and repeated SC administration
  • To assess the immunogenicity of REGN10933 and REGN10987
02

Conditions studied

  • Healthy
  • Chronic Stable Illness

Keywords

  • Coronavirus disease 2019 (COVID-19)
  • Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2)
03

In context

Lead sponsor

Regeneron Pharmaceuticals is the lead sponsor of 400 studies on the registry; 91 are open to participants now.

Of its 120 completed or terminated interventional studies of FDA-regulated products, 77 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Key Inclusion Criteria:

  1. Is healthy or has chronic medical condition(s) that is stable and well controlled as per the opinion of the investigator and is not likely to require medical intervention through the end of study
  2. Stable medication for co-morbid condition(s) for at least 6 months prior to screening
  3. Willing and able to comply with study visits and study-related procedures, including compliance with site precautionary requirements related to SARS-CoV-2 infection and transmission

Key Exclusion Criteria:

  1. Positive diagnostic test for SARS-CoV-2 infection ≤72 hours prior to randomization
  2. Subject-reported clinical history of COVID-19 as determined by investigator
  3. Subject-reported history of prior positive diagnostic test for SARS-CoV-2 infection
  4. Active respiratory or non-respiratory symptoms suggestive or consistent with COVID-19
  5. Medically attended acute illness, systemic antibiotics use, or hospitalization (ie, >24 hours) for any reason within 30 days prior to screening
  6. Acute exacerbation of a chronic pulmonary condition (eg, chronic obstructive pulmonary disease [COPD], asthma exacerbations) in the past 6 months prior to screening
  7. Received investigational or approved SARS-CoV-2 vaccine
  8. Received investigational or approved passive antibodies for SARS-CoV-2 infection prophylaxis as defined in the protocol
  9. Use of remdesivir, intravenous immunoglobulin (IVIG), or other anti-SARS viral agents within 2 months prior to screening

NOTE: Other protocol-defined Inclusion/ Exclusion criteria apply

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
974 participants (actual)

Study arms

  • Experimental
    REGN10933+REGN10987

    Drug: REGN10933+REGN10987

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugREGN10933+REGN10987

    Administered subcutaneous (SC) every 4 weeks (Q4W)

    Also known as: REGN-COV2, Casirivimab, Imdevimab, REGEN-COV™, Ronapreve™

  • DrugPlacebo

    Administered subcutaneous (SC) every 4 weeks (Q4W)

06

What researchers measure

Primary outcomes

  1. Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration

    Time frame: Within 4 days postdose at Baseline

  2. Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration

    Time frame: Within 4 days postdose at Day 29

  3. Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration

    Time frame: Within 4 days postdose at Day 57

  4. Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration

    Time frame: Within 4 days postdose at Day 85

  5. Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration

    Time frame: Within 4 days postdose at Day 113

  6. Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration

    Time frame: Within 4 days postdose at Day 141

  7. Concentrations of REGN10933 in serum over time

    Time frame: Up to 52 weeks

  8. Concentrations of REGN10987 in serum over time

    Time frame: Up to 52 weeks

Secondary outcomes

  1. Proportion of participants with treatment-emergent adverse events (TEAEs)

    Time frame: Up to 52 weeks

  2. Severity of TEAEs

    Time frame: Up to 52 weeks

  3. Proportion of participants who achieve or exceed target concentration in serum of REGN10933

    Time frame: Up to 52 weeks

  4. Proportion of participants who achieve or exceed target concentration in serum of REGN10987

    Time frame: Up to 52 weeks

  5. Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10933

    Time frame: Up to 52 weeks

  6. Immunogenicity as measured by anti-drug antibodies (ADA) to REGN10987

    Time frame: Up to 52 weeks

07

Study locations

7 sites
  • Regeneron Study Site
    Tempe, Arizona 85283, United States
  • Regeneron Study Site
    Rogers, Arkansas 72758, United States
  • Regeneron Study Site
    Sacramento, California 95864, United States
  • Regeneron Study Site
    Miami, Florida 33014, United States
  • Regeneron Study Site
    Lincoln, Nebraska 68502, United States
  • Regeneron Study Site
    Dayton, Ohio 45417, United States
  • Regeneron Study Site
    Austin, Texas 78705, United States
08

References and documents

Publications

  • Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2. PubMed 35713300 ↗
  • Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2. PubMed 34473343 ↗

Individual participant data

Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04519437
Lead sponsor
Regeneron Pharmaceuticals
Responsible party
Sponsor
First posted
Aug 19, 2020
Start date
Jul 26, 2020
Primary completion
Nov 22, 2021
Completion
Nov 22, 2021
Last update
Jan 26, 2022

Study contacts

Clinical Trial Management
study director · Regeneron Pharmaceuticals

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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