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

COMPLETEDPHASE2

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

NCT04551898•BeiGene

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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

Locations (18)

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

Key Dates

Start Date

December 2, 2020

Primary Completion Date

May 25, 2021

Completion Date

May 25, 2021

Last Updated

October 26, 2024

Enrollment

181

ACTUAL participants

Conditions

Covid19

Interventions

BGB-DXP593

DRUG

Placebo

DRUG

The Effect of the Covid-19 Pandemic Among Operated Patients

NCT04525716

Covid19Surgery

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RECRUITINGPHASE3

The VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients

NCT03188796

Critical IllnessVitamin D Deficiency+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 26, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

The Effect of the Covid-19 Pandemic Among Operated Patients

The VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients

Covid-19 and Influenza Oral Vaccine Study

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