NCT05142527

Study to Evaluate the Safety and Efficacy of a Monoclonal Antibody Cocktail for the Prevention of COVID-19

A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety, Tolerability, and Efficacy of ADM03820 to Prevent Symptomatic COVID-19 in Adult Subjects

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Alachua Government Services, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 2/3, randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety, tolerability, and efficacy of ADM03820 to prevent symptomatic COVID-19 in adult subjects (≥ 18 years of age).

Detailed description

Approximately 450 subjects will be enrolled in the Phase 2 segment of the study and will be randomized in a 2:1 ratio with a total of 300 subjects receiving ADM03820 and 150 subjects receiving placebo. In the Phase 3 segment, an additional 4,000 subjects will be enrolled and randomized in a 2:1 ratio, for a total sample size (including the Phase 2 subjects) of 4,450 total subjects. The primary objective of the Phase 2 segment is to evaluate the safety and tolerability of ADM03820 in adult subjects. The secondary objectives are to assess safety, PK, immunogenicity, and microneutralization (MN) of ADM03820 and to gather information surrounding COVID-19 incidence rates and COVID-19 symptoms to support Phase 3 assumptions and assessment of efficacy. The primary objectives of the Phase 3 segment are to evaluate the efficacy of ADM03820 for the prevention of symptomatic COVID-19 in adult subjects. The secondary objectives are to evaluate the efficacy of ADM03820 for prevention and amelioration of COVID-19 symptoms, to monitor the incidence and severity of COVID-19, and to evaluate the safety and tolerability of ADM03820.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	ADM03820	ADM03820 is a 1:1 mixture of two human IgG1 non-competitive binding anti-SARS-CoV-2 antibodies
OTHER	Placebo	Placebo

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-01-01
• Completion: 2024-04-01
• First posted: 2021-12-02
• Last updated: 2023-02-03

Regulatory

• FDA-regulated drug study