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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04551898
Recruitment Status : Completed
First Posted : September 16, 2020
Results First Posted : March 17, 2022
Last Update Posted : March 17, 2022
Sponsor:
Information provided by (Responsible Party):
BeiGene

Tracking Information
First Submitted Date  ICMJE September 10, 2020
First Posted Date  ICMJE September 16, 2020
Results First Submitted Date  ICMJE February 25, 2022
Results First Posted Date  ICMJE March 17, 2022
Last Update Posted Date March 17, 2022
Actual Study Start Date  ICMJE December 2, 2020
Actual Primary Completion Date May 25, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2022)
Change From Baseline to Day 8 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Shedding [ Time Frame: Baseline and Day 8 ]
SARS-CoV-2 viral shedding was measured by reverse transcription-quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal swab samples.
Original Primary Outcome Measures  ICMJE
 (submitted: September 15, 2020)
Change from baseline to Day 8 in SARS-CoV-2 viral shedding as measured by reverse transcription-quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal swab samples [ Time Frame: Up to 8 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2022)
  • 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 [ Time Frame: Baseline and 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 [ Time Frame: 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 [ 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 [ Time Frame: Day 29 ]
    Number of participants that died by Day 29
  • Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 174 days ]
  • 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 [ Time Frame: 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 [ 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) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2020)
  • Time-weighted average change in viral shedding as measured by RT-qPCR in nasopharyngeal swab samples [ Time Frame: Baseline to Day 15 ]
  • Change from baseline to Day 15 in SARS-CoV-2 viral shedding as measured by RT-qPCR in nasopharyngeal swab samples [ Time Frame: Baseline to Day 15 ]
  • Time to negative RT-qPCR in all tested samples with no subsequent positive RT-qPCR in any tested samples [ Time Frame: Up to 15 days ]
  • Number of participants requiring hospitalization due to worsened COVID-19 [ Time Frame: Up to 29 days ]
  • Time to resolution of all COVID-19-related symptoms [ Time Frame: Up to 29 days ]
  • All-cause mortality rate at Day 29 [ Time Frame: Up to 29 days ]
  • Number of participants experiencing Adverse Events (AEs) [ Time Frame: Up to 85 days ]
  • Number of participants experiencing Serious Adverse Events (SAEs) [ Time Frame: Up to 85 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Covid19
Intervention  ICMJE
  • Drug: BGB-DXP593
    Intravenous (IV) infusion administered over 30 to 90 minutes at a dose as specified in the treatment arm
  • Drug: Placebo
    Placebo to match BGB-DXP593 administered as specified in the treatment arm
Study Arms  ICMJE
  • Experimental: BGB-DXP593 Low Dose
    Participants will receive BGB-DXP593 on Day 1, and followed up for safety for up to 85 days
    Intervention: Drug: BGB-DXP593
  • Experimental: BGB-DXP593 Medium Dose
    Participants will receive BGB-DXP593 on Day 1, and followed up for safety for up to 85 days
    Intervention: Drug: BGB-DXP593
  • Experimental: BGB-DXP593 High Dose
    Participants will receive BGB-DXP593 on Day 1, and followed up for safety for up to 85 days
    Intervention: Drug: BGB-DXP593
  • Placebo Comparator: Placebo
    Participants will receive placebo on Day 1, and followed up for safety for up to 85 days
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 2, 2021)
181
Original Estimated Enrollment  ICMJE
 (submitted: September 15, 2020)
180
Actual Study Completion Date  ICMJE May 25, 2021
Actual Primary Completion Date May 25, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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/Exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil,   Mexico,   South Africa,   United States
Removed Location Countries Australia
 
Administrative Information
NCT Number  ICMJE NCT04551898
Other Study ID Numbers  ICMJE BGB-DXP593-102
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Current Responsible Party BeiGene
Original Responsible Party Same as current
Current Study Sponsor  ICMJE BeiGene
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Study Director BeiGene
PRS Account BeiGene
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP