Not provided
Not provided
Not provided
Not provided
Not provided
The study will no longer move forward due to recent changes in COVID-19 cases in Hong Kong.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is to evaluate the safety, efficacy and pharmacokinetics profile of human monoclonal antibodies, BRII-196 and BRII-198 compared with placebo in patients with COVID-19.
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 |
| |
| Placebo in adult subjects with severe COVID-19 | Placebo Comparator |
| |
| 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) | Day 29 | |
| Incidence of serious adverse events (SAEs) | up to Day 29 | |
| 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 72 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yao Zhang, MD | Brii Biosciences, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site 1 | Hong Kong | China |
| 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
| 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: maximum serum concentration observed (Cmax) | up to Day 85 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |