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
Verified date | March 2022 |
Source | BeiGene |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
BeiGene |
United States, Brazil, Mexico, South Africa,
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) |
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