Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04341116 | Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Subjects With Severe Coronavirus Disease 2019 (COVID-19) | PHASE2 | COMPLETED | 149 | — | — | Apr 11, 2020 | Feb 7, 2022 | May 6, 2023 | 14 | United States |
Free of mechanical ventilation was defined as proportion of subjects who scores 1 to 5 in the following 8-category ordinal scale. 8, death; 7, ventilation in addition to extracorporeal membrane oxygen (ECMO), continuous renal replacement therapy (CRRT) or pressors; 6, intubation and mechanical ventilation; 5, non-invasive mechanical ventilation (NIV) or high-flow oxygen; 4, hospitalization with oxygen by mask or nasal prongs; 3. Hospitalization without oxygen supplementation; 2, limitation of activities, discharge from hospital; and 1, no limitation of activities, discharge from hospital.
| Arm | Type | Description |
|---|---|---|
| TJ003234 Medium Dose | EXPERIMENTAL | - |
| TJ003234 Low Dose | EXPERIMENTAL | Part 1 only |
| Placebo | PLACEBO_COMPARATOR | - |
| TJ003234 High Dose | EXPERIMENTAL | Part 2 Phase 3 only |
| Name | Type | Description |
|---|---|---|
| TJ003234 | DRUG | patients receive a single infusion |
| Placebo | DRUG | patients receive a single infusion |
Inclusion Criteria: * Age: 18 years or older (including 18 years); male or female * Laboratory-confirmed SARS-CoV-2 or COVID-19 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay. * Bilateral lung infection confirmed by imaging. * Severe disease th...