Safety, Tolerability, and Efficacy of Anti-Spike SARS-CoV-2 Monoclonal Antibodies for Hospitalized 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; MedDRA version: 23.0Level: HLTClassification code 10084510Term: Coronavirus infectionsSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-002537-15-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: 2970

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 and no alternative explanation for current clinical condition. A historical record of positive result from test conducted =72 hours prior to randomization is acceptable.
•Has symptoms consistent with COVID-19, as determined by investigator, with onset =10 days before randomization
•Hospitalized for COVID-19 illness for =72 hours with at least 1 of the following at randomization; patients meeting more than one criterion will be categorized in the most severely affected category:
a. Cohort 1A: With COVID-19 symptoms but not requiring supplemental oxygen
b. Cohort 1: Maintains O2 saturation >93% on low-flow oxygen as defined in the protocol
c.Cohort 2: High-intensity oxygen therapy without mechanical ventilation as defined in the protocol
d.Cohort 3: On mechanical ventilation
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 2079
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 891

Exclusion Criteria

Key Exclusion Criteria:
•Phase 1 only: Patients maintaining O2 saturation >94% on room air
•In the opinion of the investigator, unlikely to survive for >48 hours from screening
•Receiving extracorporeal membrane oxygenation (ECMO)
•Has new-onset stroke or seizure disorder during hospitalization
•Initiated on renal replacement therapy due to COVID-19
NOTE: Other protocol defined exclusion criteria apply

Study & Design

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