COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04452318

Regeneron Pharmaceuticals, Inc. - Clinical Trials information

clinicaltrials@regeneron.com

2020-06-30

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

key inclusion criteria: adult subjects 18 years of age (irrespective of weight) and above at the signing of informed consent or adolescent participants ≥12 to <18 years of age, or pediatric participants <12 years of age at the signing of the assent (parent/guardian sign the informed consent) asymptomatic household contact with exposure to an individual with a diagnosis of sars-cov-2 infection (index case). to be included in the study, participants must be randomized within 96 hours of collection of the index cases' positive sars-cov-2 diagnostic test sample participant anticipates living in the same household with the index case until study day 29 is judged by the investigator to be in good health based on medical history and physical examination at screening/baseline, including participants who are healthy or have a chronic, stable medical condition willing and able to comply with study visits and study-related procedures/assessments. provide informed consent signed by study participant or legally acceptable representative. key

history of prior positive sars-cov-2 rt-pcr test or positive sars-cov-2 serology test at any time before the screening participant has lived with individuals who have had previous sars-cov-2 infection or currently lives with individuals who have sars-cov-2 infection, with the exception of the index case(s), the first individual(s) known to be infected in the household active respiratory or non-respiratory symptoms consistent with covid-19 history of respiratory illness with sign/symptoms of sars-cov-2 infection, in the opinion of the investigator, within the prior 6 months to screening nursing home resident any physical examination findings, and/or history of any illness, concomitant medications or recent live vaccines that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the participant by their participation in the study note: other protocol-defined inclusion/ exclusion criteria apply

2

Regeneron Pharmaceuticals

0

100

Republic of Moldova;Romania;United States

Close contacts to covid patients

N/A

3303

Cohort A and Cohort B: Number of Participants With at Least One Treatment-emergent Adverse Event (TEAEs) and Severity of TEAEs;Cohort A: Percentage of Participants Who Have a Symptomatic RT-qPCR Confirmed SARS-CoV-2 Infection (Broad-term) During the EAP;Cohort B: Percentage of Participants Who Subsequently Develop Signs and Symptoms (Broad-Term) Within 14 Days of a Positive RT-qPCR at Baseline or During the EAP

None

Phase 3

[{"arm_notes": "", "treatment_id": 1864, "treatment_name": "Casirivimab+imdevimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]