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

October 23, 2024 updated by: BeiGene

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
181

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Botucatu, Brazil, 18618-687
        • Hospital das Clínicas da Faculdade de Medicina de Botucatu
      • Caxias do Sul, Brazil, 95070-560
        • Fundacao Universidade de Caxias Do Sul
      • Sorcaba, Brazil, 18040-425
        • Consultoria Medica E Pesquisa Clinica
  • Mexico
      • Aguascalientes, Mexico, 20230
        • Hospital Cardiologica Aguascalientes
      • Monterrey, Mexico, 64310
        • IECSI
  • South Africa
      • Cape Town, South Africa, 7570
        • Langeberg Clinical Trials
      • Cape Town, South Africa, 7500
        • TASK Clinical Research Centre
  • United States
    • Florida
      • DeLand, Florida, United States, 32720
        • Btc Network Midland Florida Clinical Research Center
      • Hollywood, Florida, United States, 33023
        • Elixia Clinical Research Collaborative
      • Miami, Florida, United States, 33175
        • US Associates In Research
      • Miami, Florida, United States, 33187
        • Continental Research Network
      • Miami, Florida, United States, 33032
        • Homestead Associates in Research Inc
      • Miami, Florida, United States, 33134
        • Medical Research Center of Miami II, Inc
      • Orlando, Florida, United States, 32806
        • Orlando Health Ufhealth Cancer Center
    • Michigan
      • Dearborn, Michigan, United States, 48126
        • Revive Research Institute
      • Sterling Heights, Michigan, United States, 48313
        • Revival Research Institute Farmington Hills
    • Texas
      • Amarillo, Texas, United States, 79124
        • Amarillo Center for Clinical Research
      • Brownsville, Texas, United States, 78520
        • Panamerican Clinical Research Us Headquarters

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and Day 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time-Weighted Average Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15
Time Frame: Baseline and Day 15
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
Baseline and Day 15
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
From Baseline up to Day 21
Percentage of Participants Who Required Hospitalization Due to Worsened COVID-19
Time Frame: Baseline up to End of Study (EOS) /174 Days
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
Baseline up to EOS /174 Days
All-Cause Mortality at Day 29
Time Frame: Day 29
Number of participants that died by Day 29
Day 29
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: Up to 174 days
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)
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
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
Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)
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)
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)
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)
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)
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)
Day 1 (pre-dose) Days 15, 29, and End of study visit (up to 174 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BeiGene

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Study Director, BeiGene

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 2, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 25, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 25, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BGB-DXP593-102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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