Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibody BGB-DXP593 in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19)

Sponsor
BeiGene (Industry)
Overall Status
Completed
CT.gov ID
NCT04551898
Collaborator
(none)
181
Enrollment
30
Locations
4
Arms
5.7
Actual Duration (Months)
6
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to investigate the safety and tolerability of BGB-DXP593 administered intravenously as a single dose in participants with mild-to-moderate COVID-19.

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
181 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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 WithMild-to-Moderate COVID-19
Actual Study Start Date :
Dec 2, 2020
Actual Primary Completion Date :
May 25, 2021
Actual Study Completion Date :
May 25, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: BGB-DXP593 Low Dose

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

Drug: BGB-DXP593
Intravenous (IV) infusion administered over 30 to 60 minutes at a dose as specified in the treatment arm

Experimental: BGB-DXP593 Medium Dose

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

Drug: BGB-DXP593
Intravenous (IV) infusion administered over 30 to 60 minutes at a dose as specified in the treatment arm

Experimental: BGB-DXP593 High Dose

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

Drug: BGB-DXP593
Intravenous (IV) infusion administered over 30 to 60 minutes at a dose as specified in the treatment arm

Placebo Comparator: Placebo

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

Drug: Placebo
Placebo to match BGB-DXP593 administered as specified in the treatment arm

Outcome Measures

Primary Outcome Measures

  1. Change from baseline to Day 8 in SARS-CoV-2 viral shedding as measured by reverse transcription-quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal swab samples [Up to 8 days]

Secondary Outcome Measures

  1. Time-weighted average change in viral shedding as measured by RT-qPCR in nasopharyngeal swab samples [Baseline to Day 15]

  2. Change from baseline to Day 15 in SARS-CoV-2 viral shedding as measured by RT-qPCR in nasopharyngeal swab samples [Baseline to Day 15]

  3. Time to negative RT-qPCR in all tested samples with no subsequent positive RT-qPCR in any tested samples [Up to 15 days]

  4. Number of participants requiring hospitalization due to worsened COVID-19 [Up to 29 days]

  5. Time to resolution of all COVID-19-related symptoms [Up to 29 days]

  6. All-cause mortality rate at Day 29 [Up to 29 days]

  7. Number of participants experiencing Adverse Events (AEs) [Up to 85 days]

  8. Number of participants experiencing Serious Adverse Events (SAEs) [Up to 85 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1ElixiaHollywoodCaliforniaUnited States33023
2Midland Florida Clinical Research Center, LLCDeLandFloridaUnited States32720
3Baptist Medical CenterJacksonvilleFloridaUnited States33207
4Homestead Associates in Research Inc.MiamiFloridaUnited States33032
5Medical Research Center of Miami II, Inc.MiamiFloridaUnited States33134
6US Associates in ResearchMiamiFloridaUnited States33175
7Continental Research NetworkMiamiFloridaUnited States33187
8Omega Research OrlandoOrlandoFloridaUnited States32808
9Revival Research Institute, LLC.DearbornMichiganUnited States48126
10New Phase Research & DevelopmentKnoxvilleTennesseeUnited States37909
11Amarillo Center for Clinical ResearchAmarilloTexasUnited States79124
12PanAmerican Clinical ResearchBrownsvilleTexasUnited States78520
13The Royal Prince Alfred HospitalCamperdownAustralia
14Fundação Universidade de Caxias do Sul - Instituto de Pesquisas em SaúdePetropolisCaxias Do SulBrazil95070
15Hospital das Clínicas da Faculdade de Medicina de BotucatuBotucatuBrazil18618
16Irmandade da Santa Casa de Misericórdia de Porto AlegrePorto AlegreBrazil90020
17Hospital Universitáro de Santa Maria / UFSMSanta MariaBrazil97105
18CMPC Pesquisa ClinicaSorocabaBrazil18040
19Hospital Cardiologica AguascalientesAguascalientesMexico20230
20JM ResearchCuernavacaMexico62290
21Hospital General Dr. Manuel Gea GonzalezMexicoMexico14080
22Iecsi S.C.MonterreyMexico58249
23Clinica de Enfermedades Cronicas y de Procedimientos Especiales, S.C.MoreliaMexico58249
24Kohler & Milstein ResearchMéridaMexico97070
25PanAmerican Clinical ResearchQuerétaroMexico76226
26East Rand Research T/A Worthwhile Clinical TrialsBenoniSouth Africa1501
27TASKCape TownSouth Africa7500
28TREAD Research CCCape TownSouth Africa7505
29Langeberg Clinical TrialsCape TownSouth Africa7570
30Wits Clinical ResearchSowetoSouth Africa

Sponsors and Collaborators

  • BeiGene

Investigators

  • Study Director: Zhen Yao, MD, BeiGene

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
BeiGene
ClinicalTrials.gov Identifier:
NCT04551898
Other Study ID Numbers:
  • BGB-DXP593-102
First Posted:
Sep 16, 2020
Last Update Posted:
Dec 3, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 3, 2021