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

BeiGene

Status and phase: Completed; Phase 2

Conditions: Covid19

Treatments: Drug: Placebo; Drug: BGB-DXP593

Study type: Interventional

Funder types: Industry

Identifiers

NCT04551898

BGB-DXP593-102

Details and patient eligibility

About

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

Enrollment: 181 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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

Key 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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181 participants in 4 patient groups, including a placebo group

BGB-DXP593 Low Dose

Experimental group

Description:

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

Treatment:

Drug: BGB-DXP593

BGB-DXP593 Medium Dose

Experimental group

Description:

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

Treatment:

Drug: BGB-DXP593

BGB-DXP593 High Dose

Experimental group

Description:

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

Treatment:

Drug: BGB-DXP593

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo