Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Cx611 · 1 trial · 1 indication
AESIs are predefined adverse events (AEs) that required close monitoring and prompt reporting to the sponsor. Protocol-specific AEs considered as AESI for this study are thromboembolic events and hypersensitivity reactions such as anaphylaxis.
Hypersensitivity reactions included anaphylaxis (changes in systolic and diastolic blood pressure, core temperature, respiratory rate \[non-ventilated participants\], heart rate), episodes of skin reactions and signs and symptoms of respiratory distress, which require therapeutic intervention including drugs and/or changes in mechanical ventilation setting. Number of participants with hypersensitivity reactions were reported for this outcome measure.
| Arm | Type | Description |
|---|---|---|
| Cx611 | EXPERIMENTAL | Subjects treated in an intensive care unit for sCABP, but that may be screened at the emergency department, will receive SoC therapy according to local guidelines plus two intravenous central line infusions of Cx611 at a fixed dose of 160 million expanded allogeneic adipose-derived stem cells (eASCs) each. |
| Placebo | PLACEBO_COMPARATOR | Subjects treated in an intensive care unit for sCABP, but that may be screened at the emergency department, will receive SoC therapy according to local guidelines plus two intravenous central line infusions of Ringer Lactate. |
| Name | Type | Description |
|---|---|---|
| Cx611 | BIOLOGICAL | Two intravenous infusions, one on day 1 and another one on day 3. |
| Placebo | OTHER | Two intravenous infusions, one on day 1 and another one on day 3. |
Inclusion criteria 1. Adult subjects of either gender (aged ≥18 years and ≤80 years old.) 2. Body weight between 50 kg and 100 kg. 3. Clinical diagnosis of acute (developed within ≤21 past days) community acquired bacterial pneumonia based on the presence of two relevant signs (fever, tachypnoea, l...