Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibody BGB-DXP593 in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19)

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Covid19

Intervention / Treatment
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* Drug: BGB-DXP593
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: 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. 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 Agree to the collection of nasopharyngeal swabs, saliva, and venous blood Key Exclusion Criteria: 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 Requires mechanical ventilation or anticipated impending need for mechanical ventilation Known allergies to any of the components used in the formulation of the interventions Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing Have received treatment with a SARS-CoV-2 specific monoclonal antibody NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BGB-DXP593 Low Dose<br>Participants will receive BGB-DXP593 on Day 1, and followed up for safety for up to 85 days | Drug: BGB-DXP593<br>* Intravenous (IV) infusion administered over 30 to 90 minutes at a dose as specified in the treatment arm<br>|
| Experimental: BGB-DXP593 Medium Dose<br>Participants will receive BGB-DXP593 on Day 1, and followed up for safety for up to 85 days | Drug: BGB-DXP593<br>* Intravenous (IV) infusion administered over 30 to 90 minutes at a dose as specified in the treatment arm<br>|
| Experimental: BGB-DXP593 High Dose<br>Participants will receive BGB-DXP593 on Day 1, and followed up for safety for up to 85 days | Drug: BGB-DXP593<br>* Intravenous (IV) infusion administered over 30 to 90 minutes at a dose as specified in the treatment arm<br>|
| Placebo Comparator: Placebo<br>Participants will receive placebo on Day 1, and followed up for safety for up to 85 days | Drug: Placebo<br>* Placebo to match BGB-DXP593 administered as specified in the treatment arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and Day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | SARS-CoV-2 viral shedding was measured by RT-qPCR in nasopharyngeal swab samples | 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 | From Baseline up to Day 21 | 
| 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 | Number of participants that died by Day 29 | 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 | 
| 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 | 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 |  | 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) | 
| 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) | 
| 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) |