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 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04551898
• Other study ID #: BGB-DXP593-102
• Status: Completed
• Phase: Phase 2
• Start date: December 2, 2020
• Est. completion date: May 25, 2021

Study information

• Verified date: March 2022
• Source: BeiGene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: May 25, 2021
• Est. primary completion date: May 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• BGB-DXP593
Intravenous (IV) infusion administered over 30 to 90 minutes at a dose as specified in the treatment arm
• Placebo
Placebo to match BGB-DXP593 administered as specified in the treatment arm

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da Faculdade de Medicina de Botucatu	Botucatu
Brazil	Fundação Universidade de Caxias do Sul - Instituto de Pesquisas em Saúde	Petropolis	Caxias Do Sul
Brazil	CMPC Pesquisa Clinica	Sorocaba
Mexico	Hospital Cardiologica Aguascalientes	Aguascalientes
Mexico	Iecsi S.C.	Monterrey
South Africa	Langeberg Clinical Trials	Cape Town
South Africa	TASK	Cape Town
United States	Amarillo Center for Clinical Research	Amarillo	Texas
United States	PanAmerican Clinical Research	Brownsville	Texas
United States	Revival Research Institute, LLC.	Dearborn	Michigan
United States	Midland Florida Clinical Research Center, LLC	DeLand	Florida
United States	Baptist Medical Center	Jacksonville	Florida
United States	New Phase Research & Development	Knoxville	Tennessee
United States	Continental Research Network	Miami	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	Omega Research Orlando	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Countries where clinical trial is conducted

United States,  Brazil,  Mexico,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Day 8 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Shedding	SARS-CoV-2 viral shedding was measured by reverse transcription-quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal swab samples.	Baseline and Day 8
Secondary	Time-Weighted Average Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15		Baseline and Day 15
Secondary	Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15	SARS-CoV-2 viral shedding was measured by RT-qPCR in nasopharyngeal swab samples	Baseline and Day 15
Secondary	Time to Negative RT-qPCR in All Tested Samples	The negative RT-qPCR is defined as the value that is below the lower limit of detection	From Baseline up to Day 21
Secondary	Percentage of Participants Who Required Hospitalization Due to Worsened COVID-19		Baseline up to End of Study (EOS) /174 Days
Secondary	Time to Resolution of All COVID-19-Related Symptoms		Baseline up to EOS /174 Days
Secondary	All-Cause Mortality at Day 29	Number of participants that died by Day 29	Day 29
Secondary	Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)		Up to 174 days
Secondary	Maximum Observed Plasma Concentration (Cmax) of BGB-DXP593		Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to174 days)
Secondary	Area Under the Plasma Concentration-time Curve (AUC) of BGB-DXP593 From Time 0 to Day 29		Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, and 29
Secondary	Area Under the Plasma Concentration-time Curve (AUC) of BGB-DXP593	AUClast : AUC from time zero to the time of the last quantifiable concentration AUCinf: AUC from zero to infinite time with extrapolation of the terminal phase	Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)
Secondary	Time to Reach Cmax (Tmax) of BGB-DXP593		Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)
Secondary	Terminal Half-Life (t1/2) of BGB-DXP593		Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)
Secondary	Clearance (CL) of BGB-DXP593		Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)
Secondary	Volume of Distribution During the Terminal Phase (Vz) of BGB-DXP593		Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)
Secondary	Number of Participants With Anti-drug Antibodies (ADAs) to BGB-DXP593		Day 1 (pre-dose) Days 15, 29, and End of study visit (up to 174 days)