Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| TSB Therapeutics (Beijing) CO.LTD | INDUSTRY |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BRII-196 and BRII-198 in adult subjects with severe COVID-19 | Experimental |
| |
| BRII-196 and BRII-198 in adult subjects with mild-moderate COVID-19 | Experimental |
| |
| Placebo in adult subjects with mild-moderate COVID-19 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BRII-196 and BRII-198 | Drug | BRII-196 and BRII-198 given by intravenous administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | Up to Day 181 | |
| Incidence of serious adverse events (SAEs) | Up to Day 181 | |
| Change from pre-dose baseline in RBC count | Day 29 | |
| Change from pre-dose baseline in WBC count | Day 29 | |
| Change from pre-dose baseline in Platelets count | Day 29 | |
| Change from pre-dose baseline in Hemoglobin result | Day 29 | |
| Change from pre-dose baseline in Creatine kinase result | Day 29 | |
| Change from pre-dose baseline in Alanine aminotransferase (ALT) result | Day 29 | |
| Time-weighted average changes in SARSCoV-2 RNA levels in nasopharyngeal swabs from baseline to Day 8 | Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of COVID-19 related symptoms through Day 29 among subjects with mild-moderate COVID-19 | up to Day 29 | |
| Proportion of subjects who have mild-moderate COVID-19 and develop severe COVID-19 after randomization | up to 26 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nanshan Zhong, MD | Leading Principal Investigator, The First Affiliated Hospital of Guangzhou Medical University | Study Chair |
| Fujie Zhang, MD | Co-Study Chair, Beijing Ditan Hospital Capital Medical University | Principal Investigator |
| Jing Yuan, MD | Site-PI, The Third People's Hospital of Shenzhen | Principal Investigator |
| Xilong Deng, MMS | Site-PI, Guangzhou Eighth Hospital, Guangzhou Medical University | Principal Investigator |
| Yao Zhang, MD | TSB Therapeutics (Beijing) CO.LTD | Study Director |
| Xingxiang Xu, MD | Site-PI, Subei People's Hospital of Jiangsu province | Principal Investigator |
| Xinping Yang, BMED | Site-PI, Yunnan Provincial Infectious Disease Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Ditan Hospital Capital Medical University | Beijing | Beijing Municipality | 100015 | China | ||
| Guangzhou Eighth Hospital, Guangzhou Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34473343 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C000721042 | amubarvimab |
| C000721043 | romlusevimab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo given by intravenous administration |
|
| Assessment of PK parameters (Group A and B): maximum serum concentration observed (Cmax) | up to Day 85 |
| Guangzhou |
| Guangdong |
| 510000 |
| China |
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510000 | China |
| The Third People's Hospital of Shenzhen | Shenzhen | Guangdong | 518000 | China |
| Subei People's Hospital of Jiangsu province | Yangzhou | Jiangsu | China |
| Yunnan Provincial Infectious Disease Hospital | Kunming | Yunnan | China |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |