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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04333420 | Randomized, Controlled Study of IFX-1 in Patients With Severe COVID-19 Pneumonia | PHASE2 | COMPLETED | 399 | — | — | Mar 31, 2020 | Dec 1, 2021 | Jun 5, 2023 | 48 | Belgium, Brazil +7 |
Relative change (%) from baseline in Oxygenation Index (OI; partial pressure of oxygen in the arterial blood (PaO2) / fractional inspired oxygen (FiO2)) in supine position for ≥2 hours at day 5 (FAS)
Number and percentage of deaths (all-cause) until Day 28 (FAS)
| Arm | Type | Description |
|---|---|---|
| Phase II: IFX-1 + BSC | EXPERIMENTAL | Phase II study part: IFX-1: 800mg intravenously administered, BSC: Best supportive care |
| Phase II: BSC | OTHER | Phase II study part: BSC: Best supportive care |
| Phase III: IFX-1 + SOC | EXPERIMENTAL | Phase III study part: IFX-1: 800mg intravenously administered, SOC: Standard of care |
| Phase III: Placebo + SOC | PLACEBO_COMPARATOR | Phase III study part: Placebo: placebo infusion intravenously administered, SOC: Standard of care |
| Name | Type | Description |
|---|---|---|
| IFX-1 + BSC | DRUG | Phase II study part: IFX-1 + BSC |
| BSC | DRUG | Phase II study part: BSC |
| IFX-1 + SOC | DRUG | Phase III study part: IFX-1 + SOC |
| Placebo + SOC | DRUG | Phase III study part: Placebo + SOC |
Phase II Inclusion Criteria: * At least 18 years of age or older * Clinically evident or otherwise confirmed severe pneumonia * SARS-CoV-2 infection confirmation (tested positive in last 14 days before randomization with locally available test system) Exclusion Criteria: * Known history of progr...