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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
181
Intravenous (IV) infusion administered over 30 to 90 minutes at a dose as specified in the treatment arm
Placebo to match BGB-DXP593 administered as specified in the treatment arm
Btc Network Midland Florida Clinical Research Center
DeLand, Florida, United States
Elixia Clinical Research Collaborative
Hollywood, Florida, United States
Change From Baseline to Day 8 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Shedding
SARS-CoV-2 viral shedding was measured by reverse transcription-quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal swab samples.
Time frame: Baseline and Day 8
Time-Weighted Average Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15
Time frame: Baseline and Day 15
Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15
SARS-CoV-2 viral shedding was measured by RT-qPCR in nasopharyngeal swab samples
Time frame: Baseline and Day 15
Time to Negative RT-qPCR in All Tested Samples
The negative RT-qPCR is defined as the value that is below the lower limit of detection
Time frame: From Baseline up to Day 21
Percentage of Participants Who Required Hospitalization Due to Worsened COVID-19
Time frame: Baseline up to End of Study (EOS) /174 Days
Time to Resolution of All COVID-19-Related Symptoms
Time frame: Baseline up to EOS /174 Days
All-Cause Mortality at Day 29
Number of participants that died by Day 29
Time frame: Day 29
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up to 174 days
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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
Orlando Health Ufhealth Cancer Center
Orlando, Florida, United States
Revive Research Institute
Dearborn, Michigan, United States
Revival Research Institute Farmington Hills
Sterling Heights, Michigan, United States
Amarillo Center For Clinical Research
Amarillo, Texas, United States
...and 8 more locations
Maximum Observed Plasma Concentration (Cmax) of BGB-DXP593
Time frame: Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to174 days)
Area Under the Plasma Concentration-time Curve (AUC) of BGB-DXP593 From Time 0 to Day 29
Time frame: Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, and 29
Area Under the Plasma Concentration-time Curve (AUC) of BGB-DXP593
AUClast : AUC from time zero to the time of the last quantifiable concentration AUCinf: AUC from zero to infinite time with extrapolation of the terminal phase
Time frame: Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)
Time to Reach Cmax (Tmax) of BGB-DXP593
Time frame: Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)
Terminal Half-Life (t1/2) of BGB-DXP593
Time frame: Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)
Clearance (CL) of BGB-DXP593
Time frame: Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)
Volume of Distribution During the Terminal Phase (Vz) of BGB-DXP593
Time frame: Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)
Number of Participants With Anti-drug Antibodies (ADAs) to BGB-DXP593
Time frame: Day 1 (pre-dose) Days 15, 29, and End of study visit (up to 174 days)