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

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: Completed
• Conditions: Covid19
• Intervention / Treatment: Drug: BGB-DXP593; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 181
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • Botucatu, Brazil, 18618
    • Hospital das Clínicas da Faculdade de Medicina de Botucatu
  • Sorocaba, Brazil, 18040
    • CMPC Pesquisa Clinica
  • Caxias Do Sul
    • Petropolis, Caxias Do Sul, Brazil, 95070
      • Fundação Universidade de Caxias do Sul - Instituto de Pesquisas em Saúde
• Mexico
  • Aguascalientes, Mexico, 20230
    • Hospital Cardiológica Aguascalientes
  • Monterrey, Mexico, 58249
    • Iecsi S.C.
• South Africa
  • Cape Town, South Africa, 7500
    • TASK
  • Cape Town, South Africa, 7570
    • Langeberg Clinical Trials
• United States
  • Florida
    • DeLand, Florida, United States, 32720
      • Midland Florida Clinical Research Center, LLC
    • Jacksonville, Florida, United States, 33207
      • Baptist Medical Center
    • Miami, Florida, United States, 33032
      • Homestead Associates in Research Inc.
    • Miami, Florida, United States, 33134
      • Medical Research Center of Miami II, Inc.
    • Miami, Florida, United States, 33175
      • US Associates in Research
    • Miami, Florida, United States, 33187
      • Continental Research Network
    • Orlando, Florida, United States, 32808
      • Omega Research Orlando
  • Michigan
    • Dearborn, Michigan, United States, 48126
      • Revival Research Institute, LLC.
  • Tennessee
    • Knoxville, Tennessee, United States, 37909
      • New Phase Research & Development
  • Texas
    • Amarillo, Texas, United States, 79124
      • Amarillo Center for Clinical Research
    • Brownsville, Texas, United States, 78520
      • PanAmerican Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to Day 8 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Shedding	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

Outcome Measure	Measure Description	Time Frame
Time-Weighted Average Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15		Baseline and Day 15
Change in SARS-CoV-2 Viral Shedding From Baseline to 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	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		Baseline up to End of Study (EOS) /174 Days
Time to Resolution of All COVID-19-Related Symptoms		Baseline up to EOS /174 Days
All-Cause Mortality at 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)		Up to 174 days
Maximum Observed Plasma Concentration (Cmax) of BGB-DXP593		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		Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, and 29
Area Under the Plasma Concentration-time Curve (AUC) of BGB-DXP593	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		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		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		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		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		Day 1 (pre-dose) Days 15, 29, and End of study visit (up to 174 days)

Collaborators and Investigators

• Sponsor: BeiGene

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2020
• Primary Completion (Actual): May 25, 2021
• Study Completion (Actual): May 25, 2021

Study Registration Dates

• First Submitted: September 10, 2020
• First Submitted That Met QC Criteria: September 15, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 15, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID 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