BGB-DXP593
DrugIntravenous (IV) infusion administered over 30 to 90 minutes at a dose as specified in the treatment arm
NCT Number: NCT04551898
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
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Notify Me18 year–65 year
All sexes
Interventional
Phase 2
Hospital Das Clinicas Da Faculdade de Medicina de Botucatu, Botucatu, Brazil
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Intravenous (IV) infusion administered over 30 to 90 minutes at a dose as specified in the treatment arm
Placebo to match BGB-DXP593 administered as specified in the treatment arm
Time frame: Baseline and Day 8
SARS-CoV-2 viral shedding was measured by reverse transcription-quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal swab samples.
Time frame: Baseline and Day 15
Time frame: Baseline and Day 15
SARS-CoV-2 viral shedding was measured by RT-qPCR in nasopharyngeal swab samples
Time frame: From Baseline up to Day 21
The negative RT-qPCR is defined as the value that is below the lower limit of detection
Time frame: Baseline up to End of Study (EOS) /174 Days
Time frame: Baseline up to EOS /174 Days
Time frame: Day 29
Number of participants that died by Day 29
Time frame: Up to 174 days
Time frame: Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to174 days)
Time frame: Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, and 29
Time frame: Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)
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
Time frame: Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)
Time frame: Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)
Time frame: Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)
Time frame: Day 1 (pre-dose, End of Infusion) Days 3, 8, 15, 29, and End of study visit (up to 174 days)
Time frame: Day 1 (pre-dose) Days 15, 29, and End of study visit (up to 174 days)
BeiGene
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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