Official Title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SARS-CoV-2 Neutralizing Antibody BGB-DXP593 in Patients With Mild-to-Moderate COVID-19
Brief Summary

The primary objective of this study is to evaluate the efficacy of BGB-DXP593 administered intravenously as a single dose in participants with mild to moderate COVID-19

Completed
COVID19

Drug: BGB-DXP593

Intravenous (IV) infusion administered over 30 to 90 minutes at a dose as specified in the treatment arm

Drug: Placebo

Placebo to match BGB-DXP593 administered as specified in the treatment arm

Eligibility Criteria

Key Inclusion Criteria:

1. Laboratory-confirmed severe acute respiratory syndrome (SARS)-CoV-2 infection
(positive reverse transcription-polymerase chain reaction [RT-PCR] test or other
authorized antigen testing methods) in any samples following local practice ≤ 72 hours
prior to screening.

2. Have experienced COVID-19 symptoms for ≤ 7 days prior to treatment assignment, such as
fever, cough, shortness of breath, sore throat, diarrhea, vomiting, and dysgeusia

3. Agree to the collection of nasopharyngeal swabs, saliva, and venous blood

Key Exclusion Criteria:

1. Severe COVID-19 having oxygen saturation (SpO2) ≤ 93 % on room air at sea level or
ratio of arterial oxygen partial pressure (PaO2 in millimeters of mercury) to
fractional inspired oxygen (FiO2) < 300, respiratory rate ≥ 30/min, heart rate ≥
125/min

2. Requires mechanical ventilation or anticipated impending need for mechanical
ventilation

3. Known allergies to any of the components used in the formulation of the interventions

4. Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30
days before dosing

5. Have received treatment with a SARS-CoV-2 specific monoclonal antibody

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 65 Years
Countries
Brazil
Mexico
South Africa
United States
Locations

Midland Florida Clinical Research Center, LLC
DeLand, Florida, United States

Baptist Medical Center
Jacksonville, Florida, United States

Homestead Associates in Research Inc.
Miami, Florida, United States

Medical Research Center of Miami II, Inc.
Miami, Florida, United States

US Associates in Research
Miami, Florida, United States

Continental Research Network
Miami, Florida, United States

Omega Research Orlando
Orlando, Florida, United States

Revival Research Institute, LLC.
Dearborn, Michigan, United States

New Phase Research & Development
Knoxville, Tennessee, United States

Amarillo Center for Clinical Research
Amarillo, Texas, United States

PanAmerican Clinical Research
Brownsville, Texas, United States

Fundação Universidade de Caxias do Sul - Instituto de Pesquisas em Saúde
Petropolis, Caxias Do Sul, Brazil

Hospital das Clínicas da Faculdade de Medicina de Botucatu
Botucatu, Brazil

CMPC Pesquisa Clinica
Sorocaba, Brazil

Hospital Cardiologica Aguascalientes
Aguascalientes, Mexico

Iecsi S.C.
Monterrey, Mexico

TASK
Cape Town, South Africa

Langeberg Clinical Trials
Cape Town, South Africa

Study Director, Principal Investigator
BeiGene

NCT Number
MeSH Terms
COVID-19