Clinical trial NCT04551898: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibody BGB-DXP593 in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Covid19
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2020-09-16
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Change From Baseline to Day 8 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Shedding
timeFrame: Baseline and Day 8
Secondary outcomes:
measure: Time-Weighted Average Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15
timeFrame: Baseline and Day 15
measure: Change in SARS-CoV-2 Viral Shedding From Baseline to Day 15
timeFrame: Baseline and Day 15
measure: Time to Negative RT-qPCR in All Tested Samples
timeFrame: From Baseline up to Day 21
measure: Percentage of Participants Who Required Hospitalization Due to Worsened COVID-19
timeFrame: Baseline up to End of Study (EOS) /174 Days
measure: Time to Resolution of All COVID-19-Related Symptoms
timeFrame: Baseline up to EOS /174 Days
measure: All-Cause Mortality at Day 29
timeFrame: Day 29
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Up to 174 days
measure: Maximum Observed Plasma Concentration (Cmax) of BGB-DXP593
timeFrame: Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to174 days)
measure: Area Under the Plasma Concentration-time Curve (AUC) of BGB-DXP593 From Time 0 to Day 29
timeFrame: Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, and 29
measure: Area Under the Plasma Concentration-time Curve (AUC) of BGB-DXP593
timeFrame: Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)
measure: Time to Reach Cmax (Tmax) of BGB-DXP593
timeFrame: Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)
measure: Terminal Half-Life (t1/2) of BGB-DXP593
timeFrame: Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)
measure: Clearance (CL) of BGB-DXP593
timeFrame: Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)
measure: Volume of Distribution During the Terminal Phase (Vz) of BGB-DXP593
timeFrame: Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)
measure: Number of Participants With Anti-drug Antibodies (ADAs) to BGB-DXP593
timeFrame: Day 1 (pre-dose) Days 15, 29, and End of study visit (up to 174 days)
Other outcomes:
Locations:
city: DeLand
country: United States
facility: Btc Network Midland Florida Clinical Research Center
state: Florida
city: Hollywood
country: United States
facility: Elixia Clinical Research Collaborative
state: Florida
city: Miami
country: United States
facility: Homestead Associates in Research Inc
state: Florida
city: Miami
country: United States
facility: Medical Research Center of Miami Ii, Inc
state: Florida
city: Miami
country: United States
facility: Us Associates in Research
state: Florida
city: Miami
country: United States
facility: Continental Research Network
state: Florida
city: Orlando
country: United States
facility: Orlando Health Ufhealth Cancer Center
state: Florida
city: Dearborn
country: United States
facility: Revive Research Institute
state: Michigan
city: Sterling Heights
country: United States
facility: Revival Research Institute Farmington Hills
state: Michigan
city: Amarillo
country: United States
facility: Amarillo Center For Clinical Research
state: Texas
city: Brownsville
country: United States
facility: Panamerican Clinical Research Us Headquarters
state: Texas
city: Botucatu
country: Brazil
facility: Hospital Das Clinicas Da Faculdade de Medicina de Botucatu
city: Caxias do Sul
country: Brazil
facility: Fundacao Universidade de Caxias Do Sul
city: Sorcaba
country: Brazil
facility: Consultoria Medica E Pesquisa Clinica
city: Aguascalientes
country: Mexico
facility: Hospital Cardiologica Aguascalientes
city: Monterrey
country: Mexico
facility: IECSI
city: Cape Town
country: South Africa
facility: Task Clinical Research Centre
city: Cape Town
country: South Africa
facility: Langeberg Clinical Trials
Study officials:
affiliation: BeiGene
name: Study Director
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.