COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05081388

Clinical Trials Administrator

clinicaltrials@regeneron.com

2021-10-18

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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

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

5

Regeneron Pharmaceuticals

12

65

United States

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

25

Percentage of Participants With Hypersensitivity Reactions;Percentage of Participants With Injection-site Reactions (ISRs);Severity of Hypersensitivity Reactions Over Time;Severity of ISRs (Injection Site Reactions);Severity of TEAEs;Time-weighted Average (TWA) Daily Change From Baseline in Viral Load (log10 Copies/mL);Treatment Emergent Adverse Events (TEAEs)

None

Phase 1

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