Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Adult Patients With COVID-19

Phase 1

• Conditions: Coronavirus disease 2019 (COVID-19); MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-003690-21-RO
• Lead Sponsor: Regeneron Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-30
• Last Update Posted: 16 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1368

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified