COVID-19 Study to Evaluate Safety, Tolerability, and Efficacy of REGN14256+Imdevimab for the Treatment of COVID-19 Adult and Adolescent Patients Without Risk Factors for Progression to Severe Disease
NCT ID: NCT05081388
Last Updated: 2025-10-28
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
25 participants
INTERVENTIONAL
2021-11-08
2022-06-30
Brief Summary
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• 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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)
REGN14256
Sub-cutaneous (SC) single dose
imdevimab
SC single dose
REGN14256
Phase 1, Phase 2: Randomized 1:1:1:1:1
REGN14256
Sub-cutaneous (SC) single dose
Imdevimab
Phase 1, Phase 2: Randomized 1:1:1:1:1
imdevimab
SC single dose
casirivimab + imdevimab
Phase 1, Phase 2: Randomized 1:1:1:1:1 Phase 3: (≥18 Years): Randomized 1:1:1
imdevimab
SC single dose
casirivimab + imdevimab
SC single dose
Placebo
Phase 1, Phase 2: Randomized 1:1:1:1:1 Phase 3: (≥18 Years): Randomized 1:1:1
Placebo
SC single dose
Interventions
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REGN14256
Sub-cutaneous (SC) single dose
imdevimab
SC single dose
casirivimab + imdevimab
SC single dose
Placebo
SC single dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
12 Years
65 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Regeneron Research Site
La Mesa, California, United States
Ark Clinical Research
Long Beach, California, United States
PNS Clinical Research, LLC
Mission Viejo, California, United States
Regeneron Research Site
Ft. Pierce, Florida, United States
AGA Clinical Trials
Hialeah, Florida, United States
Regeneron Research Site
Loxahatchee Groves, Florida, United States
Project 4 Research, Inc.
Miami, Florida, United States
Universal Medical and Research Center, LLC
Miami, Florida, United States
Global Medical Trials
Miami, Florida, United States
Bio-Medical Research LLC
Miami, Florida, United States
Charisma Research and Medical Center
Miami Lakes, Florida, United States
Triple O Research Institute, P.A.
West Palm Beach, Florida, United States
Regeneron Research Site
Winter Park, Florida, United States
IACT Health
Columbus, Georgia, United States
Chicago Clinical Research Institute
Chicago, Illinois, United States
Regeneron Research Site
Ames, Iowa, United States
Regeneron Research Site
Marrero, Louisiana, United States
Olive Branch Family Medical Center
Olive Branch, Mississippi, United States
Forte Family Practice
Las Vegas, Nevada, United States
New York Health and Hospitals / Lincoln
The Bronx, New York, United States
NYC H+H / Jacobi Medical Center
The Bronx, New York, United States
Regeneron Research Site
Wilmington, North Carolina, United States
Regeneron Research Site
Dayton, Ohio, United States
Carolina Medical Research
Clinton, South Carolina, United States
PharmaTex Research, LLC
Amarillo, Texas, United States
Advanced Diagnostics Clinic, River Oaks Hospital and Clinics
Houston, Texas, United States
Regeneron Research Site
Houston, Texas, United States
Regeneron Research Site
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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R14256-COV-2149
Identifier Type: -
Identifier Source: org_study_id
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