Skip to main content
OpenTrials
Completed

NCT Number: NCT04519437

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy COVID-19 Chronic Stable Illness Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Regeneron Study Site, Tempe, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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
  • Stable medication for co-morbid condition(s) for at least 6 months prior to screening
  • 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:

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

Treatment and study plan

REGN10933+REGN10987

Drug

Administered subcutaneous (SC) every 4 weeks (Q4W)

Other names: REGN-COV2, Casirivimab, Imdevimab, REGEN-COV™, Ronapreve™

Placebo

Drug

Administered subcutaneous (SC) every 4 weeks (Q4W)

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

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-Blind, Placebo-Controlled 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 19, 2020
Registry last updated
Jan 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.