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

• 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: BeiGene
• Information provided by (Responsible Party): BeiGene

Tracking Information

• First Submitted Date: September 10, 2020
• First Posted Date: September 16, 2020
• Results First Submitted Date: February 25, 2022
• Results First Posted Date: March 17, 2022
• Last Update Posted Date: March 17, 2022
• Actual Study Start Date: December 2, 2020
• Actual Primary Completion Date: May 25, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]

Current Secondary Outcome Measures (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 (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: 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
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Covid19

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 2, 2021): 181
• Original Estimated Enrollment (submitted: September 15, 2020): 180
• Actual Study Completion Date: May 25, 2021
• Actual Primary Completion Date: May 25, 2021 (Final data collection date for primary outcome measure)

Eligibility 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/Exclusion criteria may apply.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil, Mexico, South Africa, United States
• Removed Location Countries: Australia

Administrative Information

• NCT Number: NCT04551898
• Other Study ID Numbers: 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

• Plan to Share IPD: Yes

• Current Responsible Party: BeiGene
• Original Responsible Party: Same as current
• Current Study Sponsor: BeiGene
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Study Director; BeiGene

• PRS Account: BeiGene
• Verification Date: March 2022