Print

Purpose

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

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

More Details

NCT ID
NCT04551898
Status
Completed
Sponsor
BeiGene

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.