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
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
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.
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