Back to resultsSevere Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibody BGB-DXP593 in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19)
Primary Purpose
Covid19
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BGB-DXP593
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
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.
Sites / Locations
- Midland Florida Clinical Research Center, LLC
- Baptist Medical Center
- Homestead Associates in Research Inc.
- Medical Research Center of Miami II, Inc.
- US Associates in Research
- Continental Research Network
- Omega Research Orlando
- Revival Research Institute, LLC.
- New Phase Research & Development
- Amarillo Center for Clinical Research
- PanAmerican Clinical Research
- Fundação Universidade de Caxias do Sul - Instituto de Pesquisas em Saúde
- Hospital das Clínicas da Faculdade de Medicina de Botucatu
- CMPC Pesquisa Clinica
- Hospital Cardiologica Aguascalientes
- Iecsi S.C.
- TASK
- Langeberg Clinical Trials
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
BGB-DXP593 Low Dose
BGB-DXP593 Medium Dose
BGB-DXP593 High Dose
Placebo
Arm Description
Participants will receive BGB-DXP593 on Day 1, and followed up for safety for up to 85 days
Participants will receive BGB-DXP593 on Day 1, and followed up for safety for up to 85 days
Participants will receive BGB-DXP593 on Day 1, and followed up for safety for up to 85 days
Participants will receive placebo on Day 1, and followed up for safety for up to 85 days
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Time-Weighted Average Change in SARS-CoV-2 Viral Shedding From Baseline to 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 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
Percentage of Participants Who Required Hospitalization Due to Worsened COVID-19
Time to Resolution of All COVID-19-Related Symptoms
All-Cause Mortality at Day 29
Number of participants that died by Day 29
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Maximum Observed Plasma Concentration (Cmax) of BGB-DXP593
Area Under the Plasma Concentration-time Curve (AUC) of BGB-DXP593 From Time 0 to Day 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 to Reach Cmax (Tmax) of BGB-DXP593
Terminal Half-Life (t1/2) of BGB-DXP593
Clearance (CL) of BGB-DXP593
Volume of Distribution During the Terminal Phase (Vz) of BGB-DXP593
Number of Participants With Anti-drug Antibodies (ADAs) to BGB-DXP593
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04551898
Brief Title
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibody BGB-DXP593 in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 2, 2020 (Actual)
Primary Completion Date
May 25, 2021 (Actual)
Study Completion Date
May 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BeiGene
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
181 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BGB-DXP593 Low Dose
Arm Type
Experimental
Arm Description
Participants will receive BGB-DXP593 on Day 1, and followed up for safety for up to 85 days
Arm Title
BGB-DXP593 Medium Dose
Arm Type
Experimental
Arm Description
Participants will receive BGB-DXP593 on Day 1, and followed up for safety for up to 85 days
Arm Title
BGB-DXP593 High Dose
Arm Type
Experimental
Arm Description
Participants will receive BGB-DXP593 on Day 1, and followed up for safety for up to 85 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo on Day 1, and followed up for safety for up to 85 days
Intervention Type
Drug
Intervention Name(s)
BGB-DXP593
Intervention Description
Intravenous (IV) infusion administered over 30 to 90 minutes at a dose as specified in the treatment arm
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to match BGB-DXP593 administered as specified in the treatment arm
Primary Outcome Measure Information:
Title
Change From Baseline to Day 8 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Shedding
Description
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
Secondary Outcome Measure Information:
Title
Time-Weighted Average Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15
Time Frame
Baseline and Day 15
Title
Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15
Description
SARS-CoV-2 viral shedding was measured by RT-qPCR in nasopharyngeal swab samples
Time Frame
Baseline and Day 15
Title
Time to Negative RT-qPCR in All Tested Samples
Description
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
Title
Percentage of Participants Who Required Hospitalization Due to Worsened COVID-19
Time Frame
Baseline up to End of Study (EOS) /174 Days
Title
Time to Resolution of All COVID-19-Related Symptoms
Time Frame
Baseline up to EOS /174 Days
Title
All-Cause Mortality at Day 29
Description
Number of participants that died by Day 29
Time Frame
Day 29
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame
Up to 174 days
Title
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)
Title
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
Title
Area Under the Plasma Concentration-time Curve (AUC) of BGB-DXP593
Description
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
BeiGene
Official's Role
Principal Investigator
Facility Information:
Facility Name
Midland Florida Clinical Research Center, LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Baptist Medical Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
33207
Country
United States
Facility Name
Homestead Associates in Research Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33032
Country
United States
Facility Name
Medical Research Center of Miami II, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
US Associates in Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Continental Research Network
City
Miami
State/Province
Florida
ZIP/Postal Code
33187
Country
United States
Facility Name
Omega Research Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32808
Country
United States
Facility Name
Revival Research Institute, LLC.
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48126
Country
United States
Facility Name
New Phase Research & Development
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Amarillo Center for Clinical Research
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79124
Country
United States
Facility Name
PanAmerican Clinical Research
City
Brownsville
State/Province
Texas
ZIP/Postal Code
78520
Country
United States
Facility Name
Fundação Universidade de Caxias do Sul - Instituto de Pesquisas em Saúde
City
Petropolis
State/Province
Caxias Do Sul
ZIP/Postal Code
95070
Country
Brazil
Facility Name
Hospital das Clínicas da Faculdade de Medicina de Botucatu
City
Botucatu
ZIP/Postal Code
18618
Country
Brazil
Facility Name
CMPC Pesquisa Clinica
City
Sorocaba
ZIP/Postal Code
18040
Country
Brazil
Facility Name
Hospital Cardiologica Aguascalientes
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
Facility Name
Iecsi S.C.
City
Monterrey
ZIP/Postal Code
58249
Country
Mexico
Facility Name
TASK
City
Cape Town
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Langeberg Clinical Trials
City
Cape Town
ZIP/Postal Code
7570
Country
South Africa
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
34473343
Citation
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
Results Reference
derived
Learn more about this trial
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibody BGB-DXP593 in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19)
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