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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)

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ClinicalTrials.gov Identifier: NCT04551898
Recruitment Status : Completed
First Posted : September 16, 2020
Last Update Posted : March 4, 2021
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Description
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Brief Summary:
The primary objective of this study is to investigate the safety and tolerability 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 WithMild-to-Moderate COVID-19
Actual Study Start Date : December 2, 2020
Actual Primary Completion Date : January 25, 2021
Actual Study Completion Date : January 25, 2021

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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 60 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 60 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 60 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 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 ]

Secondary Outcome Measures :
  1. Time-weighted average change in viral shedding as measured by RT-qPCR in nasopharyngeal swab samples [ Time Frame: Baseline to Day 15 ]
  2. 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 ]
  3. 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 ]
  4. Number of participants requiring hospitalization due to worsened COVID-19 [ Time Frame: Up to 29 days ]
  5. Time to resolution of all COVID-19-related symptoms [ Time Frame: Up to 29 days ]
  6. All-cause mortality rate at Day 29 [ Time Frame: Up to 29 days ]
  7. Number of participants experiencing Adverse Events (AEs) [ Time Frame: Up to 85 days ]
  8. Number of participants experiencing Serious Adverse Events (SAEs) [ Time Frame: Up to 85 days ]

Eligibility Criteria
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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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Study Director: Zhen Yao, MD BeiGene
More Information
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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
Last Update Posted: March 4, 2021
Last Verified: March 2021
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