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
SARS-CoV-2
About this trial
This is an interventional treatment trial for SARS-CoV-2 focused on measuring COVID-19, Non-hospitalized, Low-risk, Symptomatic, Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2), coronavirus
Eligibility 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:
- For the adolescent cohort in Phase 3 only: Weighs ≥40 kg at randomization
- 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
- 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
- Maintains O2 saturation ≥93% on room air
Key Exclusion Criteria:
Has a medical condition or other factors associated with high risk for progression to severe COVID-19:
- Cancer
- Cardiovascular disease (such as heart failure, coronary artery disease, cardiomyopathies, congenital heart disease or hypertension)
- Chronic lung disease including chronic obstructive pulmonary disease, asthma (moderate to severe), interstitial lung disease, cystic fibrosis, and pulmonary hypertension
- Chronic kidney disease at any stage
- Chronic liver disease (such as alcohol-related, nonalcoholic fatty liver disease, cirrhosis)
- Dementia or other chronic neurological condition
- Diabetes mellitus (type 1 or type 2)
- Immunodeficiency disease or taking immunosuppressive treatment
- Medical-related technological dependence [for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19)]
- Neurodevelopmental disorder (for example, cerebral palsy) or other condition that confers medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies)
- Overweight (defined as BMI >25 kg/m2) or obesity (defined as BMI ≥30 kg/m2)
- Poorly controlled HIV infection or AIDS
- Pregnancy
- Sickle cell disease or thalassemia
- Stroke or cerebrovascular disease
- 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
- Was admitted to a hospital for COVID-19 prior to randomization, or is hospitalized (inpatient) for any reason at randomization
- Has a known prior SARS-CoV-2 infection or positive SARS-CoV-2 serologic test
- Has a positive SARS-CoV-2 antigen or molecular diagnostic test from a sample collected >72 hours prior to randomization
- 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
- 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)
- Has known active infection with influenza or other non-SARS-CoV-2 respiratory pathogen, confirmed by a diagnostic test
- Has been discharged, or is planned to be discharged, to a quarantine center
- Has participated, is participating, or plans to participate in a clinical research study evaluating any authorized, approved, or investigational vaccine for COVID-19
- 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
Sites / Locations
- Regeneron Research Site
- Ark Clinical Research
- PNS Clinical Research, LLC
- Regeneron Research Site
- AGA Clinical Trials
- Regeneron Research Site
- Charisma Research and Medical Center
- Project 4 Research, Inc.
- Universal Medical and Research Center, LLC
- Global Medical Trials
- Bio-Medical Research LLC
- Triple O Research Institute, P.A.
- Regeneron Research Site
- IACT Health
- Chicago Clinical Research Institute
- Regeneron Research Site
- Regeneron Research Site
- Olive Branch Family Medical Center
- Forte Family Practice
- New York Health and Hospitals / Lincoln
- NYC H+H / Jacobi Medical Center
- Regeneron Research Site
- Regeneron Research Site
- Carolina Medical Research
- PharmaTex Research, LLC
- Advanced Diagnostics Clinic, River Oaks Hospital and Clinics
- Regeneron Research Site
- Regeneron Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
REGN14256 + imdevimab
REGN14256
Imdevimab
casirivimab + imdevimab
Placebo
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)
Phase 1, Phase 2: Randomized 1:1:1:1:1
Phase 1, Phase 2: Randomized 1:1:1:1:1
Phase 1, Phase 2: Randomized 1:1:1:1:1 Phase 3: (≥18 Years): Randomized 1:1:1
Phase 1, Phase 2: Randomized 1:1:1:1:1 Phase 3: (≥18 Years): Randomized 1:1:1