COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04519437

Regeneron Pharmaceuticals - Clinical Trials Administrator

clinicaltrials@regeneron.com

2020-08-19

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

key inclusion criteria: is healthy or has chronic medical condition(s) that is stable and well controlled as per the opinion of the investigator and is not likely to require medical intervention through the end of study stable medication for co-morbid condition(s) for at least 6 months prior to screening willing and able to comply with study visits and study-related procedures, including compliance with site precautionary requirements related to sars-cov-2 infection and transmission key

positive diagnostic test for sars-cov-2 infection ≤72 hours prior to randomization subject-reported clinical history of covid-19 as determined by investigator subject-reported history of prior positive diagnostic test for sars-cov-2 infection active respiratory or non-respiratory symptoms suggestive or consistent with covid-19 medically attended acute illness, systemic antibiotics use, or hospitalization (ie, >24 hours) for any reason within 30 days prior to screening acute exacerbation of a chronic pulmonary condition (eg, chronic obstructive pulmonary disease [copd], asthma exacerbations) in the past 6 months prior to screening received investigational or approved sars-cov-2 vaccine received investigational or approved passive antibodies for sars-cov-2 infection prophylaxis as defined in the protocol use of remdesivir, intravenous immunoglobulin (ivig), or other anti-sars viral agents within 2 months prior to screening note: other protocol-defined inclusion/ exclusion criteria apply

2

Regeneron Pharmaceuticals

18

90

United States

Healthy volunteers

N/A

974

Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration;Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration;Concentrations of REGN10933 in serum over time;Concentrations of REGN10987 in serum over time;Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration;Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration;Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration;Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration

None

Phase 1

[{"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"}]