A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS CoV 2 Monoclonal Antibodies for the Treatment of Ambulatory Patients with COVID-19

Regeneron Pharmaceuticals, Inc.0 个研究点目标入组 1,368 人开始时间: 2020年9月30日最近更新: 2022年5月16日

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•Key Inclusion Criteria:
•-Has SARS-CoV-2-positive antigen or molecular diagnostic test (by validated SARS-CoV-2 antigen, RT-PCR, or other molecular diagnostic assay, using an appropriate sample such as NP, nasal, oropharyngeal [OP], or saliva) =72 hours prior to randomization. A historical record of positive result from test conducted =72 hours prior to randomization is acceptable.
•-Meets one of the following 2 criteria:
•a. Symptomatic Cohort (All Phases): Has symptoms consistent with COVID-19, as determined by the investigator, with onset =7 days before randomization or
•b. Asymptomatic Cohort (Phase 2): Meets all of the following:
•-Has had no symptoms consistent with COVID-19 (as determined by the investigator) occurring at any time <2 months prior to randomization
•-Has had no positive SARS-CoV-2 test results from a sample collected >7 days prior to randomization
•-Has had no known contact (of any duration) with an individual who has confirmed COVID-19 or confirmed positive SARS-COV-2 test result >14 days prior to randomization.
•NOTE: Other Protocol defined Inclusion criteria apply
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 1259
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 109

•Key Exclusion Criteria:
•-Has been admitted to a hospital prior to randomization, or is hospitalized (inpatient) at randomization, due to COVID-19
•-Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, monoclonal antibodies (mAbs) against SARS-CoV-2, or intravenous immunoglobulin (IVIG) within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit
•-Prior, current, or planned future use of any of the following treatments: COVID-19 convalescent plasma, mAbs against SARS-CoV-2, intravenous immunoglobulin (IVIG) (any indication), systemic corticosteroids (any indication), or COVID-19 EUA-approved treatments, where prior use is defined as the past 30 days or less than 5 half-lives of the investigational product (which is longer) from screening
•NOTE: Other Protocol defined Exclusion criteria apply

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