COVID-19 Study Assessing the Safety and Tolerability of Co-Formulated Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) in Adult Volunteers

NCT05181683 | Completed Phase 1 FDA Drug

• 1 other identifier: R10933-10987-COV-2179
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief Summary

The primary objective of the study is to assess the safety and tolerability of co-formulated subcutaneous (SC) and intravenous (IV) casirivimab+imdevimab The secondary objectives of the study are to:

• Explore variability in the drug concentration profiles of casirivimab and imdevimab after co-formulated subcutaneous (SC) or intravenous (IV) administration
• Characterize the immunogenicity of casirivimab and imdevimab in serum over time

Conditions

Healthy; Chronic Stable Illness

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Targeted grade ≥3 treatment-emergent adverse events (TEAEs)

  Through end of study, approximately 16 weeks

• Grade ≥3 injection-site reactions (ISRs)

  Through end of study, approximately 16 weeks

• Grade ≥2 infusion-related reactions (IRRs)

  Through end of study, approximately 16 weeks

• Grade ≥2 hypersensitivity reactions

  Through end of study, approximately 16 weeks

• Serious adverse events (SAEs)

  Through end of study, approximately 16 weeks

Secondary Outcomes (3)

• Concentrations of casirivimab and imdevimab in serum over time

  Up to 16 weeks

• Incidence and titer of anti-drug antibodies (ADA) to casirivimab and imdevimab

  Up to 16 weeks

• Incidence of neutralizing antibodies (NAb) to casirivimab and imdevimab

  Up to 16 weeks

Study Arms (2)

Co-formulated casirivimab+imdevimab SC

EXPERIMENTAL

Randomized 1:1

Drug: Casirivimab+Imdevimab

Co-formulated casirivimab+imdevimab IV

EXPERIMENTAL

Randomized 1:1

Drug: Casirivimab+Imdevimab

Interventions

Casirivimab+Imdevimab DRUG

Randomized 1:1 for intravenous (IV) or subcutaneous (SC) administration

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

Co-formulated casirivimab+imdevimab IV; Co-formulated casirivimab+imdevimab SC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is healthy, or has chronic medical condition(s) that per the opinion of the investigator is (are) stable, well-controlled, and not likely to require medical intervention through the end of study
• Does not require medication(s) for co-morbid condition, or has received stable medication(s) for co-morbid condition(s) for at least 6 months prior to screening
• Weighs between ≥60 kg and ≤100 kg at the time of screening
• Has SARS-CoV-2-negative reverse-transcriptase polymerase chain reaction (RT-PCR) from a sample collected ≤72 hours prior to randomization, using local assay and sample collection and assay standards
• Has completed a full course of COVID-19 vaccination more than 6 weeks prior to randomization

You may not qualify if:

• Has active respiratory or non-respiratory symptoms consistent with COVID-19 in the opinion of the Investigator
• Has recent SARS-CoV-2 infection that resolved within 6 weeks prior to randomization
• Prior use of casirivimab+imdevimab at any time prior to randomization
• Prior, current, or planned use during the study of any of the following treatments: COVID-19 convalescent plasma, other monoclonal antibodies against SARS-CoV-2 (eg, bamlanivimab and etesevimab, sotrovimab), intravenous immunoglobulin (any indication), or any other investigational, authorized, or approved agent intended for COVID-19 treatment or prevention (with the exception of COVID-19 vaccines)
• Treatment with another investigational drug in the last 30 days or within 5 half-lives of the investigational drug, whichever is longer, prior to screening
• Body mass index (BMI) ≥28 kg/m2
• Medically-attended acute illness, systemic antibiotics use, or hospitalization 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
• Uncontrolled hypertension, in the opinion of the investigator
• History of heart failure hospitalization, diagnosis of a myocardial infarction, stroke, transient ischemic attack, unstable angina, percutaneous or surgical revascularization procedure (coronary, carotid, or peripheral vascular), or intracardiac device placement (eg, pacemaker) within 12 months prior to screening
• Cancer requiring treatment currently or in the past 5 years, except for non-melanoma skin cancer or cervical/anus in-situ
• Is pregnant at screening

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (2)

Regeneron Study Site

Miami, Florida, 33186, United States

Location

Regeneron StudySite

Winter Park, Florida, 32789, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

casirivimab and imdevimab drug combination; casirivimab; imdevimab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 6, 2022
• Study Start: January 7, 2022
• Primary Completion: June 3, 2022
• Study Completion: June 3, 2022
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

US (2)