Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibody BGB-DXP593 in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19)
- Registration Number
- NCT04551898
- Lead Sponsor
- BeiGene
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 181
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will receive placebo on Day 1, and followed up for safety for up to 85 days BGB-DXP593 Low Dose BGB-DXP593 Participants will receive BGB-DXP593 on Day 1, and followed up for safety for up to 85 days BGB-DXP593 Medium Dose BGB-DXP593 Participants will receive BGB-DXP593 on Day 1, and followed up for safety for up to 85 days BGB-DXP593 High Dose BGB-DXP593 Participants will receive BGB-DXP593 on Day 1, and followed up for safety for up to 85 days
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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 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) 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) 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
Trial Locations
- Locations (18)
Btc Network Midland Florida Clinical Research Center
🇺🇸DeLand, Florida, United States
Elixia Clinical Research Collaborative
🇺🇸Hollywood, Florida, United States
Consultoria Medica E Pesquisa Clinica
🇧🇷Sorcaba, Brazil
IECSI
🇲🇽Monterrey, Mexico
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
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
Panamerican Clinical Research Us Headquarters
🇺🇸Brownsville, Texas, United States
Hospital Das Clinicas Da Faculdade de Medicina de Botucatu
🇧🇷Botucatu, Brazil
Fundacao Universidade de Caxias Do Sul
🇧🇷Caxias do Sul, Brazil
Task Clinical Research Centre
🇿🇦Cape Town, South Africa
Continental Research Network
🇺🇸Miami, Florida, United States
Hospital Cardiologica Aguascalientes
🇲🇽Aguascalientes, Mexico
Langeberg Clinical Trials
🇿🇦Cape Town, South Africa