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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05081388
Recruitment Status : Recruiting
First Posted : October 18, 2021
Last Update Posted : November 26, 2021
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:

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 or disease Intervention/treatment Phase
SARS-CoV-2 Drug: REGN14256 Drug: imdevimab Drug: casirivimab + imdevimab Drug: Placebo Phase 1 Phase 2

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1359 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase1/Phase2/Phase3
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1/2/3 Adaptive Study to Evaluate the Safety, Tolerability, and Efficacy of REGN14256+Imdevimab for the Treatment of COVID-19 Patients Without Risk Factors for Progression to Severe Disease
Actual Study Start Date : November 8, 2021
Estimated Primary Completion Date : November 10, 2022
Estimated Study Completion Date : November 10, 2022


Arm Intervention/treatment
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 Name: 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 Name: 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 Name: REGN10987

Drug: casirivimab + imdevimab
SC single dose
Other Names:
  • REGN10933 + REGN10987
  • REGN-COV2
  • REGEN-COV™
  • Ronpreve™

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




Primary Outcome Measures :
  1. Treatment emergent adverse events (TEAEs) [ Time Frame: Through Day 29 ]
    Phase 1

  2. Severity of TEAEs [ Time Frame: Through Day 29 ]
    Phase 1

  3. Proportion of patients with injection-site reactions (ISRs) [ Time Frame: Through Day 169 ]
    Phase 1

  4. Severity of ISRs [ Time Frame: Through Day 169 ]
    Phase 1

  5. Proportion of patients with hypersensitivity reactions [ Time Frame: Through Day 169 ]
    Phase 1

  6. Severity of hypersensitivity reactions over time [ Time Frame: Through Day 169 ]
    Phase 1

  7. Time-weighted average (TWA) daily change from baseline in viral load (log10 copies/mL) [ Time Frame: Day 1 to day 7 ]
    Phase 1/2 Measured by SARS-CoV-2 quantitative reverse transcription polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples

  8. Time to COVID-19 symptoms resolution [ Time Frame: Through Day 169 ]
    Phase 1/2/3


Secondary Outcome Measures :
  1. Proportion of patients with treatment-emergent serious adverse events (SAEs) [ Time Frame: Through Day 169 ]
    Phase 1

  2. TEAEs [ Time Frame: Through Day 29 ]
    Phase 2 and Phase 3

  3. Severity of TEAEs [ Time Frame: Through Day 29 ]
    Phase 2 and Phase 3

  4. Proportion of patients with ISRs [ Time Frame: Through Day 169 ]
    Phase 2 and Phase 3

  5. Severity of ISRs [ Time Frame: Through Day 169 ]
    Phase 2 and Phase 3

  6. Proportion of patients with hypersensitivity reactions [ Time Frame: Through Day 169 ]
    Phase 2 and Phase 3

  7. Severity of hypersensitivity reactions over time [ Time Frame: Through Day 169 ]
    Phase 2 and Phase 3

  8. Proportion of patients with treatment-emergent SAEs [ Time Frame: Through Day 169 ]
    Phase 2 and Phase 3

  9. Time-weighted average change from baseline in viral load [ Time Frame: Through Day 169 ]
    Phase 1, Phase 2, and Phase 3 Measured by RT-qPCR in NP samples

  10. Change from baseline in viral load [ Time Frame: Through Day 7 ]
    Phase 1, Phase 2, and Phase 3 As measured by RT-qPCR in NP samples

  11. Proportion of patients with viral loads below the limit of detection [ Time Frame: Through Day 169 ]
    Phase 1, Phase 2, and Phase 3

  12. Concentrations of REGN14256 in serum over time [ Time Frame: Through Day 169 ]
    Phase 1, Phase 2, and Phase 3

  13. Concentrations of imdevimab in serum over time [ Time Frame: Through Day 169 ]
    Phase 1, Phase 2, and Phase 3

  14. Incidence and titer of anti-drug antibodies (ADA) to REGN14256 over time [ Time Frame: Through Day 169 ]
    Phase 1, Phase 2, and Phase 3

  15. Incidence and titer of ADA to imdevimab over time [ Time Frame: Through Day 169 ]
    Phase 1, Phase 2, and Phase 3



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Phase 1 will enroll adult patients (≥18 years of age), Phase 2 will enroll adult patients Phase 3 will enroll adult patients and an additional adolescent cohort of patients (≥12 and <18 years of age)

Key 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
  4. 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 m. Pregnancy

    n. Sickle cell disease or thalassemia o. 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05081388


Contacts
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Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com

Locations
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United States, California
Regeneron Research Site Not yet recruiting
La Mesa, California, United States, 91941
PNS Clinical Research, LLC Not yet recruiting
Mission Viejo, California, United States, 92691
Contact    714-545-5550      
Principal Investigator: Alejandro Alva, MD         
United States, Florida
AGA Clinical Trials Recruiting
Hialeah, Florida, United States, 33012
Contact    305-819-1551 ext 0      
Principal Investigator: Dario D. Altamarino, D.O.         
Charisma Research and Medical Center Not yet recruiting
Miami Lakes, Florida, United States, 33014
Contact    786-580-3845      
Principal Investigator: Marimer Rensoli Velazquez         
Global Medical Trials Not yet recruiting
Miami, Florida, United States, 33174
Contact    786-360-2869      
Principal Investigator: Rogelio Iglesias, MD         
Triple O Research Institute, P.A. Recruiting
West Palm Beach, Florida, United States, 33407
Contact    561-855-7871      
Principal Investigator: Olayemi Osiyemi, MD         
United States, Georgia
Regeneron Research Site Recruiting
Columbus, Georgia, United States, 31904
United States, Illinois
Chicago Clinical Research Institute Recruiting
Chicago, Illinois, United States, 60607
Contact    312-791-3241      
Principal Investigator: Dennis Levinson         
United States, Mississippi
Olive Branch Family Medical Center Recruiting
Olive Branch, Mississippi, United States, 38654
Contact    662-895-4949      
Principal Investigator: Randall T Huling, Jr, MD         
United States, South Carolina
Carolina Medical Research Recruiting
Clinton, South Carolina, United States, 29325
Contact    864-547-1321      
Principal Investigator: Nancy Patel         
United States, Texas
PharmaTex Research, LLC Not yet recruiting
Amarillo, Texas, United States, 79109
Contact    806-355-2581      
Principal Investigator: David Brabham, DO         
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05081388    
Other Study ID Numbers: R14256-COV-2149
2021-004760-10 ( EudraCT Number )
First Posted: October 18, 2021    Key Record Dates
Last Update Posted: November 26, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Regeneron Pharmaceuticals:
COVID-19
Non-hospitalized
Low-risk
Symptomatic
Coronavirus disease 2019 (COVID-19)
Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2)
coronavirus
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases