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

NCT04551898 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: BGB-DXP593-102
• Study Type: interventional
• Target: 181
• Locations: 4 countries
• Sites: 18

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

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• 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

  Baseline and Day 15

• Time to Negative RT-qPCR in All Tested Samples

  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

Study Arms (4)

BGB-DXP593 Low Dose

EXPERIMENTAL

Participants will receive BGB-DXP593 on Day 1, and followed up for safety for up to 85 days

Drug: BGB-DXP593

BGB-DXP593 Medium Dose

EXPERIMENTAL

Participants will receive BGB-DXP593 on Day 1, and followed up for safety for up to 85 days

Drug: BGB-DXP593

BGB-DXP593 High Dose

EXPERIMENTAL

Participants will receive BGB-DXP593 on Day 1, and followed up for safety for up to 85 days

Drug: BGB-DXP593

Placebo

PLACEBO COMPARATOR

Participants will receive placebo on Day 1, and followed up for safety for up to 85 days

Drug: Placebo

Interventions

BGB-DXP593 DRUG

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

BGB-DXP593 High Dose; BGB-DXP593 Low Dose; BGB-DXP593 Medium Dose

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BeiGene: lead

Study Sites (18)

Btc Network Midland Florida Clinical Research Center

DeLand, Florida, 32720, United States

Location

Elixia Clinical Research Collaborative

Hollywood, Florida, 33023, United States

Location

Homestead Associates in Research Inc

Miami, Florida, 33032, United States

Location

Medical Research Center of Miami Ii, Inc

Miami, Florida, 33134, United States

Location

Us Associates in Research

Miami, Florida, 33175, United States

Location

Continental Research Network

Miami, Florida, 33187, United States

Location

Orlando Health Ufhealth Cancer Center

Orlando, Florida, 32806, United States

Location

Revive Research Institute

Dearborn, Michigan, 48126, United States

Location

Revival Research Institute Farmington Hills

Sterling Heights, Michigan, 48313, United States

Location

Amarillo Center For Clinical Research

Amarillo, Texas, 79124, United States

Location

Panamerican Clinical Research Us Headquarters

Brownsville, Texas, 78520, United States

Location

Hospital Das Clinicas Da Faculdade de Medicina de Botucatu

Botucatu, 18618-687, Brazil

Location

Fundacao Universidade de Caxias Do Sul

Caxias do Sul, 95070-560, Brazil

Location

Consultoria Medica E Pesquisa Clinica

Sorcaba, 18040-425, Brazil

Location

Hospital Cardiologica Aguascalientes

Aguascalientes, 20230, Mexico

Location

IECSI

Monterrey, 64310, Mexico

Location

Task Clinical Research Centre

Cape Town, 7500, South Africa

Location

Langeberg Clinical Trials

Cape Town, 7570, South Africa

Location

Related Publications (2)

• Vega R, Antila M, Perez C, Mookadam M, Xie F, Zhang W, Rizwan A, Yao Z, Rasko JEJ. SARS-CoV-2-neutralising antibody BGB-DXP593 in mild-to-moderate COVID-19: a multicentre, randomised, double-blind, phase 2 trial. EClinicalMedicine. 2023 Mar;57:101832. doi: 10.1016/j.eclinm.2023.101832. Epub 2023 Feb 16.

  PMID: 36820098 DERIVED

• 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.

  PMID: 34473343 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Study Director
• Organization: BeiGene

clinicaltrials@beigene.com

+1-877-828-5568

Study Officials

• Study Director

  BeiGene

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: September 16, 2020
• Study Start: December 2, 2020
• Primary Completion: May 25, 2021
• Study Completion: May 25, 2021
• Last Updated: October 26, 2024
• Results First Posted: March 17, 2022

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

ZA (2); US (11); BR (3); ME (2)