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Completed

NCT Number: NCT04551898

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 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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Das Clinicas Da Faculdade de Medicina de Botucatu, Botucatu, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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.
  • 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
  • Agree to the collection of nasopharyngeal swabs, saliva, and venous blood

Key Exclusion Criteria:

  • 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
  • Requires mechanical ventilation or anticipated impending need for mechanical ventilation
  • Known allergies to any of the components used in the formulation of the interventions
  • Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing
  • Have received treatment with a SARS-CoV-2 specific monoclonal antibody

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

BGB-DXP593

Drug

Intravenous (IV) infusion administered over 30 to 90 minutes at a dose as specified in the treatment arm

Placebo

Drug

Placebo to match BGB-DXP593 administered as specified in the treatment arm

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

BeiGene

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 16, 2020
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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