Phase 2
N=181
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibody BGB-DXP593 in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19)
Covid19
Bottom Line
View on ClinicalTrials.gov: NCT04551898 ↗Enrolled (actual)
181
Serious AEs
2.8%
Results posted
Mar 2022
Primary outcome: Primary: Change From Baseline to Day 8 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Shedding — -2.88; -3.52; -3.75; -3.03 log10 copies/ml — p=0.4829
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BGB-DXP593 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- BeiGene
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Day 8 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Shedding |
-2.88; -3.52; -3.75; -3.03 | 0.4829 |
| SECONDARY Time-Weighted Average Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15 |
-2.56; -2.93; -2.87; -2.55 | — |
| SECONDARY Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15 |
-4.16; -4.29; -4.31; -4.04 | — |
| SECONDARY Time to Negative RT-qPCR in All Tested Samples |
17.00; 15.00; 10.00; 17.00 | — |
| SECONDARY Percentage of Participants Who Required Hospitalization Due to Worsened COVID-19 |
4.3; 2.2; 2.3; 0.0 | — |
| SECONDARY Time to Resolution of All COVID-19-Related Symptoms |
16.5; 15.0; 19.0; 14.0 | — |
| SECONDARY All-Cause Mortality at Day 29 |
2.13; 0; 0; 0 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
6; 6; 4; 7; 1; 1 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of BGB-DXP593 |
132.95; 368.22; 714.17 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve (AUC) of BGB-DXP593 From Time 0 to Day 29 |
1188.7; 3014.3; 6609.2 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve (AUC) of BGB-DXP593 |
1829.3; 4707.5; 10259.5; 2098.7; 4996.3; 10509.2 | — |
| SECONDARY Time to Reach Cmax (Tmax) of BGB-DXP593 |
1.500; 1.500; 1.500 | — |
| SECONDARY Terminal Half-Life (t1/2) of BGB-DXP593 |
21.4; 23.2; 20.8 | — |
| SECONDARY Clearance (CL) of BGB-DXP593 |
0.21; 0.25; 0.24 | — |
| SECONDARY Volume of Distribution During the Terminal Phase (Vz) of BGB-DXP593 |
6.58; 8.07; 7.33 | — |
| SECONDARY Number of Participants With Anti-drug Antibodies (ADAs) to BGB-DXP593 |
1; 0; 0; 0; 0; 0 | — |
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 Criteria
Key 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
Key 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
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT04551898). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.