Covid19
Conditions
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
Interventions
DRUGBGB-DXP593
Intravenous (IV) infusion administered over 30 to 90 minutes at a dose as specified in the treatment arm
DRUGPlacebo
Placebo to match BGB-DXP593 administered as specified in the treatment arm
Sponsors
BeiGene
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Day 8 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Shedding | Baseline and Day 8 | SARS-CoV-2 viral shedding was measured by reverse transcription-quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal swab samples. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Volume of Distribution During the Terminal Phase (Vz) of BGB-DXP593 | 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 | Day 1 (pre-dose) Days 15, 29, and End of study visit (up to 174 days) | — |
| Area Under the Plasma Concentration-time Curve (AUC) of BGB-DXP593 | Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days) | 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 to Reach Cmax (Tmax) of BGB-DXP593 | 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 | Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days) | — |
| Time-Weighted Average Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15 | Baseline and Day 15 | — |
| Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15 | Baseline and Day 15 | SARS-CoV-2 viral shedding was measured by RT-qPCR in nasopharyngeal swab samples |
| Clearance (CL) of BGB-DXP593 | Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days) | — |
| Percentage of Participants Who Required Hospitalization Due to Worsened COVID-19 | Baseline up to End of Study (EOS) /174 Days | — |
| Time to Resolution of All COVID-19-Related Symptoms | Baseline up to EOS /174 Days | — |
| All-Cause Mortality at Day 29 | Day 29 | Number of participants that died by Day 29 |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Up to 174 days | — |
| Maximum Observed Plasma Concentration (Cmax) of BGB-DXP593 | 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 | Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, and 29 | — |
| Time to Negative RT-qPCR in All Tested Samples | From Baseline up to Day 21 | The negative RT-qPCR is defined as the value that is below the lower limit of detection |
Countries
Brazil, Mexico, South Africa, United States
Participant flow
Recruitment details
This study was conducted in 20 centers and 181 participants were treated.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Single intravenous infusion of placebo solution administered over 30 to 90 minutes | 47 |
| BGB-DXP593 5 mg/kg Single intravenous infusion of 5 mg/kg DXP593 administered over 30 to 90 minutes | 45 |
| BGB-DXP593 15 mg/kg Single intravenous infusion of 15 mg/kg DXP593 administered over 30 to 90 minutes | 43 |
| BGB-DXP593 30 mg/kg Single intravenous infusion of 30 mg/kg DXP593 administered over 30 to 90 minutes | 46 |
| Total | 181 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 1 | 0 | 0 | 0 |
| Overall Study | Incorrectly randomized and screen failed due to administrative error | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 1 | 2 | 2 |
| Overall Study | Participant randomized but did not receive study drug | 0 | 1 | 3 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 1 | 2 | 2 |
Baseline characteristics
| Characteristic | Placebo | Total | BGB-DXP593 30 mg/kg | BGB-DXP593 15 mg/kg | BGB-DXP593 5 mg/kg |
|---|---|---|---|---|---|
| Age, Continuous | 44.3 years STANDARD_DEVIATION 14.02 | 43.8 years STANDARD_DEVIATION 13.91 | 41.1 years STANDARD_DEVIATION 13.35 | 43.6 years STANDARD_DEVIATION 12.43 | 46.2 years STANDARD_DEVIATION 15.56 |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 8 Participants | 2 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 15 Participants | 5 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 10 Participants | 6 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 40 Participants | 147 Participants | 33 Participants | 39 Participants | 35 Participants |
| Sex: Female, Male Female | 20 Participants | 86 Participants | 27 Participants | 22 Participants | 17 Participants |
| Sex: Female, Male Male | 27 Participants | 95 Participants | 19 Participants | 21 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 47 | 0 / 44 | 0 / 40 | 0 / 45 |
| other Total, other adverse events | 5 / 47 | 4 / 44 | 4 / 40 | 7 / 45 |
| serious Total, serious adverse events | 2 / 47 | 2 / 44 | 1 / 40 | 0 / 45 |
Outcome results
Primary
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
Population: Intent To Treat (ITT) analysis set. Participants with available data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Day 8 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Shedding | -2.88 log10 copies/ml | Standard Deviation 2.241 |
| BGB-DXP593 5 mg/kg | Change From Baseline to Day 8 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Shedding | -3.52 log10 copies/ml | Standard Deviation 2.831 |
| BGB-DXP593 15 mg/kg | Change From Baseline to Day 8 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Shedding | -3.75 log10 copies/ml | Standard Deviation 2.513 |
| BGB-DXP593 30 mg/kg | Change From Baseline to Day 8 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Shedding | -3.03 log10 copies/ml | Standard Deviation 2.239 |
p-value: 0.482990% CI: [-0.84, 0.34]Mixed Models Analysis
p-value: 0.173990% CI: [-1.13, 0.11]Mixed Models Analysis
p-value: 0.600690% CI: [-0.4, 0.77]Mixed Models Analysis
p-value: 0.4996t-test, 1 sided
Secondary
All-Cause Mortality at Day 29
Number of participants that died by Day 29
Time frame: Day 29
Population: ITT analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | All-Cause Mortality at Day 29 | 2.13 Percentage of participants |
| BGB-DXP593 5 mg/kg | All-Cause Mortality at Day 29 | 0 Percentage of participants |
| BGB-DXP593 15 mg/kg | All-Cause Mortality at Day 29 | 0 Percentage of participants |
| BGB-DXP593 30 mg/kg | All-Cause Mortality at Day 29 | 0 Percentage of participants |
Secondary
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)
Population: PK analysis set includes all participants who have received the study drug per protocol and for whom PK data are available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Area Under the Plasma Concentration-time Curve (AUC) of BGB-DXP593 | AUClast | 1829.3 day*μg/mL |
| Placebo | Area Under the Plasma Concentration-time Curve (AUC) of BGB-DXP593 | AUCInf | 2098.7 day*μg/mL |
| BGB-DXP593 5 mg/kg | Area Under the Plasma Concentration-time Curve (AUC) of BGB-DXP593 | AUClast | 4707.5 day*μg/mL |
| BGB-DXP593 5 mg/kg | Area Under the Plasma Concentration-time Curve (AUC) of BGB-DXP593 | AUCInf | 4996.3 day*μg/mL |
| BGB-DXP593 15 mg/kg | Area Under the Plasma Concentration-time Curve (AUC) of BGB-DXP593 | AUClast | 10259.5 day*μg/mL |
| BGB-DXP593 15 mg/kg | Area Under the Plasma Concentration-time Curve (AUC) of BGB-DXP593 | AUCInf | 10509.2 day*μg/mL |
Secondary
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
Population: PK analysis set includes all participants who have received the study drug per protocol and for whom PK data are available.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Area Under the Plasma Concentration-time Curve (AUC) of BGB-DXP593 From Time 0 to Day 29 | 1188.7 day*μg/mL |
| BGB-DXP593 5 mg/kg | Area Under the Plasma Concentration-time Curve (AUC) of BGB-DXP593 From Time 0 to Day 29 | 3014.3 day*μg/mL |
| BGB-DXP593 15 mg/kg | Area Under the Plasma Concentration-time Curve (AUC) of BGB-DXP593 From Time 0 to Day 29 | 6609.2 day*μg/mL |
Secondary
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
Population: ITT analysis set. Participants with available samples were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15 | -4.16 log10 copies/ml | Standard Deviation 2.446 |
| BGB-DXP593 5 mg/kg | Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15 | -4.29 log10 copies/ml | Standard Deviation 2.675 |
| BGB-DXP593 15 mg/kg | Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15 | -4.31 log10 copies/ml | Standard Deviation 2.851 |
| BGB-DXP593 30 mg/kg | Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15 | -4.04 log10 copies/ml | Standard Deviation 2.577 |
Secondary
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)
Population: Pharmacokinetic (PK) analysis set includes all participants who have received the study drug per protocol and for whom PK data are available.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Clearance (CL) of BGB-DXP593 | 0.21 Liters/Day |
| BGB-DXP593 5 mg/kg | Clearance (CL) of BGB-DXP593 | 0.25 Liters/Day |
| BGB-DXP593 15 mg/kg | Clearance (CL) of BGB-DXP593 | 0.24 Liters/Day |
Secondary
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)
Population: Pharmacokinetic (PK) analysis set includes all participants who have received the study drug per protocol and for whom PK data are available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Observed Plasma Concentration (Cmax) of BGB-DXP593 | 132.95 µg/mL | Standard Deviation 53.18 |
| BGB-DXP593 5 mg/kg | Maximum Observed Plasma Concentration (Cmax) of BGB-DXP593 | 368.22 µg/mL | Standard Deviation 232.04 |
| BGB-DXP593 15 mg/kg | Maximum Observed Plasma Concentration (Cmax) of BGB-DXP593 | 714.17 µg/mL | Standard Deviation 149.198 |
Secondary
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)
Population: The ADA Analysis Set includes all the participants who have received the study drug and in whom both baseline ADA and at least 1 postbaseline ADA results are available
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Anti-drug Antibodies (ADAs) to BGB-DXP593 | Treatment Induced | 1 Number of participants |
| Placebo | Number of Participants With Anti-drug Antibodies (ADAs) to BGB-DXP593 | Neutralizing antibody Positive | 0 Number of participants |
| BGB-DXP593 5 mg/kg | Number of Participants With Anti-drug Antibodies (ADAs) to BGB-DXP593 | Treatment Induced | 0 Number of participants |
| BGB-DXP593 5 mg/kg | Number of Participants With Anti-drug Antibodies (ADAs) to BGB-DXP593 | Neutralizing antibody Positive | 0 Number of participants |
| BGB-DXP593 15 mg/kg | Number of Participants With Anti-drug Antibodies (ADAs) to BGB-DXP593 | Treatment Induced | 0 Number of participants |
| BGB-DXP593 15 mg/kg | Number of Participants With Anti-drug Antibodies (ADAs) to BGB-DXP593 | Neutralizing antibody Positive | 0 Number of participants |
Secondary
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up to 174 days
Population: Safety analysis set includes all participants who received the study drug or placebo.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | With at Least One TEAE | 6 Number of participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Serious TEAE | 2 Number of participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Grade 3 or Higher TEAE | 1 Number of participants |
| BGB-DXP593 5 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | With at Least One TEAE | 6 Number of participants |
| BGB-DXP593 5 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Serious TEAE | 2 Number of participants |
| BGB-DXP593 5 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Grade 3 or Higher TEAE | 1 Number of participants |
| BGB-DXP593 15 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Grade 3 or Higher TEAE | 1 Number of participants |
| BGB-DXP593 15 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | With at Least One TEAE | 4 Number of participants |
| BGB-DXP593 15 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Serious TEAE | 1 Number of participants |
| BGB-DXP593 30 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | With at Least One TEAE | 7 Number of participants |
| BGB-DXP593 30 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Serious TEAE | 0 Number of participants |
| BGB-DXP593 30 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Grade 3 or Higher TEAE | 0 Number of participants |
Secondary
Percentage of Participants Who Required Hospitalization Due to Worsened COVID-19
Time frame: Baseline up to End of Study (EOS) /174 Days
Population: ITT analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Required Hospitalization Due to Worsened COVID-19 | 4.3 Percentage of participants |
| BGB-DXP593 5 mg/kg | Percentage of Participants Who Required Hospitalization Due to Worsened COVID-19 | 2.2 Percentage of participants |
| BGB-DXP593 15 mg/kg | Percentage of Participants Who Required Hospitalization Due to Worsened COVID-19 | 2.3 Percentage of participants |
| BGB-DXP593 30 mg/kg | Percentage of Participants Who Required Hospitalization Due to Worsened COVID-19 | 0.0 Percentage of participants |
Secondary
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)
Population: Pharmacokinetic (PK) analysis set includes all participants who have received the study drug per protocol and for whom PK data are available.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Terminal Half-Life (t1/2) of BGB-DXP593 | 21.4 Day |
| BGB-DXP593 5 mg/kg | Terminal Half-Life (t1/2) of BGB-DXP593 | 23.2 Day |
| BGB-DXP593 15 mg/kg | Terminal Half-Life (t1/2) of BGB-DXP593 | 20.8 Day |
Secondary
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
Population: ITT analysis set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Negative RT-qPCR in All Tested Samples | 17.00 Days |
| BGB-DXP593 5 mg/kg | Time to Negative RT-qPCR in All Tested Samples | 15.00 Days |
| BGB-DXP593 15 mg/kg | Time to Negative RT-qPCR in All Tested Samples | 10.00 Days |
| BGB-DXP593 30 mg/kg | Time to Negative RT-qPCR in All Tested Samples | 17.00 Days |
Secondary
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)
Population: Pharmacokinetic (PK) analysis set includes all participants who have received the study drug per protocol and for whom PK data are available.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Reach Cmax (Tmax) of BGB-DXP593 | 1.500 hours |
| BGB-DXP593 5 mg/kg | Time to Reach Cmax (Tmax) of BGB-DXP593 | 1.500 hours |
| BGB-DXP593 15 mg/kg | Time to Reach Cmax (Tmax) of BGB-DXP593 | 1.500 hours |
Secondary
Time to Resolution of All COVID-19-Related Symptoms
Time frame: Baseline up to EOS /174 Days
Population: ITT analysis set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Resolution of All COVID-19-Related Symptoms | 16.5 Days |
| BGB-DXP593 5 mg/kg | Time to Resolution of All COVID-19-Related Symptoms | 15.0 Days |
| BGB-DXP593 15 mg/kg | Time to Resolution of All COVID-19-Related Symptoms | 19.0 Days |
| BGB-DXP593 30 mg/kg | Time to Resolution of All COVID-19-Related Symptoms | 14.0 Days |
Secondary
Time-Weighted Average Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15
Time frame: Baseline and Day 15
Population: ITT analysis set. Participants with available samples were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Time-Weighted Average Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15 | -2.56 log10 copies/ml | Standard Deviation 1.718 |
| BGB-DXP593 5 mg/kg | Time-Weighted Average Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15 | -2.93 log10 copies/ml | Standard Deviation 1.997 |
| BGB-DXP593 15 mg/kg | Time-Weighted Average Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15 | -2.87 log10 copies/ml | Standard Deviation 2.049 |
| BGB-DXP593 30 mg/kg | Time-Weighted Average Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15 | -2.55 log10 copies/ml | Standard Deviation 1.785 |
Secondary
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)
Population: Pharmacokinetic (PK) analysis set includes all participants who have received the study drug per protocol and for whom PK data are available.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Volume of Distribution During the Terminal Phase (Vz) of BGB-DXP593 | 6.58 Liters |
| BGB-DXP593 5 mg/kg | Volume of Distribution During the Terminal Phase (Vz) of BGB-DXP593 | 8.07 Liters |
| BGB-DXP593 15 mg/kg | Volume of Distribution During the Terminal Phase (Vz) of BGB-DXP593 | 7.33 Liters |