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A Study of Human Monoclonal Antibodies, BRII-196 and BRII-198

NCT04787211 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-03-03

No results posted yet for this study

Summary

The aim of this phase 2 study is to evaluate the safety and efficacy of single dose IV infusion of BRII-196 and BRII-198 given as combination therapy in patients with severe COVID-19, and mild to moderate COVID-19 and asymptomatic carrier.

Conditions

Interventions

DRUG

BRII-196 and BRII-198

BRII-196 and BRII-198 given by intravenous administration

DRUG

Placebo

Placebo given by intravenous administration

Sponsors & Collaborators

  • TSB Therapeutics (Beijing) CO.LTD

    collaborator INDUSTRY

  • Brii Biosciences Limited

    lead INDUSTRY

Principal Investigators

  • Nanshan Zhong, MD · Leading Principal Investigator, The First Affiliated Hospital of Guangzhou Medical University

  • Fujie Zhang, MD · Co-Study Chair, Beijing Ditan Hospital Capital Medical University

  • Jing Yuan, MD · Site-PI, The Third People's Hospital of Shenzhen

  • Xilong Deng, MMS · Site-PI, Guangzhou Eighth Hospital, Guangzhou Medical University

  • Yao Zhang, MD · TSB Therapeutics (Beijing) CO.LTD

  • Xingxiang Xu, MD · Site-PI, Subei People's Hospital of Jiangsu province

  • Xinping Yang, BMED · Site-PI, Yunnan Provincial Infectious Disease Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-20
Primary Completion
2021-12-02
Completion
2021-12-02

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04787211 on ClinicalTrials.gov