Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04551898




Registration number
NCT04551898
Ethics application status
Date submitted
10/09/2020
Date registered
16/09/2020
Date last updated
17/03/2022

Titles & IDs
Public title
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibody BGB-DXP593 in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19)
Scientific 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
Secondary ID [1] 0 0
BGB-DXP593-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Covid19 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BGB-DXP593
Treatment: Drugs - Placebo

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

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

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

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


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

Treatment: Drugs: Placebo
Placebo to match BGB-DXP593 administered as specified in the treatment arm
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline to Day 8 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Shedding
Timepoint [1] 0 0
Baseline and Day 8
Secondary outcome [1] 0 0
Time-Weighted Average Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15
Timepoint [1] 0 0
Baseline and Day 15
Secondary outcome [2] 0 0
Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15
Timepoint [2] 0 0
Baseline and Day 15
Secondary outcome [3] 0 0
Time to Negative RT-qPCR in All Tested Samples
Timepoint [3] 0 0
From Baseline up to Day 21
Secondary outcome [4] 0 0
Percentage of Participants Who Required Hospitalization Due to Worsened COVID-19
Timepoint [4] 0 0
Baseline up to End of Study (EOS) /174 Days
Secondary outcome [5] 0 0
Time to Resolution of All COVID-19-Related Symptoms
Timepoint [5] 0 0
Baseline up to EOS /174 Days
Secondary outcome [6] 0 0
All-Cause Mortality at Day 29
Timepoint [6] 0 0
Day 29
Secondary outcome [7] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Timepoint [7] 0 0
Up to 174 days
Secondary outcome [8] 0 0
Maximum Observed Plasma Concentration (Cmax) of BGB-DXP593
Timepoint [8] 0 0
Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to174 days)
Secondary outcome [9] 0 0
Area Under the Plasma Concentration-time Curve (AUC) of BGB-DXP593 From Time 0 to Day 29
Timepoint [9] 0 0
Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, and 29
Secondary outcome [10] 0 0
Area Under the Plasma Concentration-time Curve (AUC) of BGB-DXP593
Timepoint [10] 0 0
Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)
Secondary outcome [11] 0 0
Time to Reach Cmax (Tmax) of BGB-DXP593
Timepoint [11] 0 0
Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)
Secondary outcome [12] 0 0
Terminal Half-Life (t1/2) of BGB-DXP593
Timepoint [12] 0 0
Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)
Secondary outcome [13] 0 0
Clearance (CL) of BGB-DXP593
Timepoint [13] 0 0
Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)
Secondary outcome [14] 0 0
Volume of Distribution During the Terminal Phase (Vz) of BGB-DXP593
Timepoint [14] 0 0
Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)
Secondary outcome [15] 0 0
Number of Participants With Anti-drug Antibodies (ADAs) to BGB-DXP593
Timepoint [15] 0 0
Day 1 (pre-dose) Days 15, 29, and End of study visit (up to 174 days)

Eligibility
Key inclusion criteria
Key

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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/05/2021
Sample size
Target
Accrual to date
Final
181
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
Tennessee
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Brazil
State/province [5] 0 0
Caxias Do Sul
Country [6] 0 0
Brazil
State/province [6] 0 0
Botucatu
Country [7] 0 0
Brazil
State/province [7] 0 0
Sorocaba
Country [8] 0 0
Mexico
State/province [8] 0 0
Aguascalientes
Country [9] 0 0
Mexico
State/province [9] 0 0
Monterrey
Country [10] 0 0
South Africa
State/province [10] 0 0
Cape Town

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
BeiGene
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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
Trial website
https://clinicaltrials.gov/ct2/show/NCT04551898
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
BeiGene
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04551898