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

NCT ID: NCT04551898

Last Updated: 2024-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 181 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-02
• Study Completion Date: 2021-05-25

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BGB-DXP593 Low Dose

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

Group Type: EXPERIMENTAL

BGB-DXP593

Intervention Type: DRUG

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

BGB-DXP593 Medium Dose

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

Group Type: EXPERIMENTAL

BGB-DXP593

Intervention Type: DRUG

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

BGB-DXP593 High Dose

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

Group Type: EXPERIMENTAL

BGB-DXP593

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

BGB-DXP593

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BeiGene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: PRINCIPAL_INVESTIGATOR

BeiGene

Locations

Btc Network Midland Florida Clinical Research Center

DeLand, Florida, United States

Elixia Clinical Research Collaborative

Hollywood, Florida, United States

Homestead Associates in Research Inc

Miami, Florida, United States

Medical Research Center of Miami Ii, Inc

Miami, Florida, United States

Us Associates in Research

Miami, Florida, United States

Continental Research Network

Miami, Florida, United States

Orlando Health Ufhealth Cancer Center

Orlando, Florida, United States

Revive Research Institute

Dearborn, Michigan, United States

Revival Research Institute Farmington Hills

Sterling Heights, Michigan, United States

Amarillo Center For Clinical Research

Amarillo, Texas, United States

Panamerican Clinical Research Us Headquarters

Brownsville, Texas, United States

Hospital Das Clinicas Da Faculdade de Medicina de Botucatu

Botucatu, , Brazil

Fundacao Universidade de Caxias Do Sul

Caxias do Sul, , Brazil

Consultoria Medica E Pesquisa Clinica

Sorcaba, , Brazil

Hospital Cardiologica Aguascalientes

Aguascalientes, , Mexico

IECSI

Monterrey, , Mexico

Task Clinical Research Centre

Cape Town, , South Africa

Langeberg Clinical Trials

Cape Town, , South Africa

Countries

United States; Brazil; Mexico; South Africa

References

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.

Reference Type: DERIVED

PMID: 36820098 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34473343 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

BGB-DXP593-102

Identifier Type: -

Identifier Source: org_study_id