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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

Study Description
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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

Condition or disease Intervention/treatment Phase
Covid19 Drug: BGB-DXP593 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 181 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : December 2, 2020
Actual Primary Completion Date : May 25, 2021
Actual Study Completion Date : May 25, 2021

Resource links provided by the National Library of Medicine


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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Time-Weighted Average Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15 [ Time Frame: Baseline and Day 15 ]
  2. 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

  3. 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

  4. Percentage of Participants Who Required Hospitalization Due to Worsened COVID-19 [ Time Frame: Baseline up to End of Study (EOS) /174 Days ]
  5. Time to Resolution of All COVID-19-Related Symptoms [ Time Frame: Baseline up to EOS /174 Days ]
  6. All-Cause Mortality at Day 29 [ Time Frame: Day 29 ]
    Number of participants that died by Day 29

  7. Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 174 days ]
  8. 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) ]
  9. 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 ]
  10. 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

  11. 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) ]
  12. 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) ]
  13. 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) ]
  14. 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) ]
  15. 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) ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04551898


Locations
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Sponsors and Collaborators
BeiGene
Investigators
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Principal Investigator: Study Director BeiGene
  Study Documents (Full-Text)

Documents provided by BeiGene:
Study Protocol  [PDF] October 27, 2020
Statistical Analysis Plan  [PDF] March 4, 2021

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT04551898    
Other Study ID Numbers: BGB-DXP593-102
First Posted: September 16, 2020    Key Record Dates
Results First Posted: March 17, 2022
Last Update Posted: March 17, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases