CompletedPhase 2

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

United States181 participantsStarted 2020-12-02

Plain-language 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

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

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

Timeframe: Baseline and Day 8

Trial details

NCT IDNCT04551898

SponsorBeiGene

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-05-25

Results submitted2022-02-25

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