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Purpose

Primary Objectives Phase 1 (Safety and Tolerability) • Evaluate the safety and tolerability of REGN14256+imdevimab and REGN14256 monotherapy, as measured by treatment-emergent adverse events (TEAEs), injection-site reactions (ISRs), and hypersensitivity reactions Phase 1/2 (Virologic Efficacy) • Evaluate the virologic efficacy of REGN14256+imdevimab and REGN14256 monotherapy compared to placebo, as measured by time-weighted average (TWA) change from baseline in viral load through day 7 Phase 1/2/3 (Clinical Efficacy) • Evaluate the clinical efficacy of REGN14256+imdevimab compared to placebo, as measured by COVID-19 symptoms resolution Secondary Objectives Phase 1 (Safety and Tolerability) • Evaluate the safety and tolerability of REGN14256+imdevimab and REGN14256 monotherapy, as measured by treatment-emergent serious adverse events (SAEs) Phase 2 and Phase 3 (Safety and Tolerability) • Evaluate the safety and tolerability of REGN14256+imdevimab and REGN14256 monotherapy, as measured by TEAEs, ISRs, hypersensitivity reactions, and SAEs Phase 1, Phase 2, and Phase 3 (Virologic Efficacy, Drug Concentration, and Immunogenicity) - Evaluate additional indicators of virologic efficacy of REGN14256+imdevimab and REGN14256 monotherapy - Characterize the concentration-time profile of REGN14256 administered in combination with imdevimab or alone as a monotherapy - Assess the immunogenicity of REGN14256 administered in combination with imdevimab or alone as a monotherapy

Condition

Eligibility

Eligible Ages
Between 12 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. For the adolescent cohort in Phase 3 only: Weighs ≥40 kg at randomization 2. Has SARS-CoV-2-positive antigen or molecular diagnostic test (by validated SARSCoV-2 antigen, RT-PCR, or other molecular diagnostic assay, using an appropriate sample such as nasopharyngeal [NP], nasal, oropharyngeal [OP], or saliva) ≤72 hours prior to randomization. A historical record of a positive result is acceptable as long as the sample was collected ≤72 hours prior to randomization 3. Has symptoms consistent with COVID-19 (as determined by the investigator) with onset ≤7 days before randomization, and doesn't have a medical condition or other factors associated with high risk for progression to severe COVID-19 as outlined in the

Exclusion Criteria

  1. Maintains O2 saturation ≥93% on room air Key Exclusion Criteria: 1. Has a medical condition or other factors associated with high risk for progression to severe COVID-19: 1. Cancer 2. Cardiovascular disease (such as heart failure, coronary artery disease, cardiomyopathies, congenital heart disease or hypertension) 3. Chronic lung disease including chronic obstructive pulmonary disease, asthma (moderate to severe), interstitial lung disease, cystic fibrosis, and pulmonary hypertension 4. Chronic kidney disease at any stage 5. Chronic liver disease (such as alcohol-related, nonalcoholic fatty liver disease, cirrhosis) 6. Dementia or other chronic neurological condition 7. Diabetes mellitus (type 1 or type 2) 8. Immunodeficiency disease or taking immunosuppressive treatment 9. Medical-related technological dependence [for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19)] 10. Neurodevelopmental disorder (for example, cerebral palsy) or other condition that confers medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies) 11. Overweight (defined as BMI >25 kg/m2) or obesity (defined as BMI ≥30 kg/m2) 12. Poorly controlled HIV infection or AIDS 13. Pregnancy 14. Sickle cell disease or thalassemia 15. Stroke or cerebrovascular disease 2. Prior, current (at randomization) or planned use (within time period given per CDC guidance [90 days]) of any authorized or approved vaccine for COVID-19 3. Was admitted to a hospital for COVID-19 prior to randomization, or is hospitalized (inpatient) for any reason at randomization 4. Has a known prior SARS-CoV-2 infection or positive SARS-CoV-2 serologic test 5. Has a positive SARS-CoV-2 antigen or molecular diagnostic test from a sample collected >72 hours prior to randomization 6. Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, mAbs against SARS-CoV-2, or intravenous immunoglobulin (IVIG) within 3 months or within 5 half-lives of the investigational product (whichever is longer) prior to the screening visit 7. Prior, current, or any of the following treatments: COVID-19 convalescent plasma, mAbs against SARS-CoV-2, IVIG (any indication), systemic corticosteroids (any indication), or COVID-19 treatments (authorized, approved, or investigational) 8. Has known active infection with influenza or other non-SARS-CoV-2 respiratory pathogen, confirmed by a diagnostic test 9. Has been discharged, or is planned to be discharged, to a quarantine center 10. Has participated, is participating, or plans to participate in a clinical research study evaluating any authorized, approved, or investigational vaccine for COVID-19 11. For Phase 1only: Women of childbearing potential (WOCBP) who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment and for at least 6 months after study drug administration as described in the protocol Note: Other protocol-defined inclusion/ exclusion criteria apply

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Phase1/Phase2/Phase3
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
REGN14256 + imdevimab 		Phase 1, Phase 2: Randomized 1:1:1:1:1 Phase 3: (≥18 Years): Randomized 1:1:1 Phase 3: (Open label) (≥12 and <18 Years)
  • Drug: REGN14256
    Sub-cutaneous (SC) single dose
  • Drug: imdevimab
    SC single dose
    Other names:
    • REGN10987
Experimental
REGN14256 		Phase 1, Phase 2: Randomized 1:1:1:1:1
  • Drug: REGN14256
    Sub-cutaneous (SC) single dose
Experimental
Imdevimab 		Phase 1, Phase 2: Randomized 1:1:1:1:1
  • Drug: imdevimab
    SC single dose
    Other names:
    • REGN10987
Experimental
casirivimab + imdevimab 		Phase 1, Phase 2: Randomized 1:1:1:1:1 Phase 3: (≥18 Years): Randomized 1:1:1
  • Drug: imdevimab
    SC single dose
    Other names:
    • REGN10987
  • Drug: casirivimab + imdevimab
    SC single dose
    Other names:
    • REGN10933 + REGN10987
    • REGN-COV2
    • REGEN-COV™
    • Ronapreve™
Experimental
Placebo 		Phase 1, Phase 2: Randomized 1:1:1:1:1 Phase 3: (≥18 Years): Randomized 1:1:1
  • Drug: Placebo
    SC single dose

Recruiting Locations

More Details

NCT ID
NCT05081388
Status
Terminated
Sponsor
Regeneron Pharmaceuticals

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.