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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02690038 | Ig PRx in AECOPD: Pilot Study | PHASE2 | COMPLETED | 48 | — | — | Sep 1, 2016 | Nov 20, 2019 | Nov 27, 2019 | 1 | Canada |
Average number of patients being recruited per month. The study meets primary outcome if at least 4 patients can be recruited per month on average.
Number and percentage of recruited patients adhere to the allocated treatment and protocol. We aim to achieve 80% adherence rate which is defined as at least 80% of patients adhere to 80% of allocated treatment and protocol
| Arm | Type | Description |
|---|---|---|
| Intervention Arm 1: Treatment | EXPERIMENTAL | Baseline Ig \< 7g/L group - Intravenous immunoglobulin (IVIG) 0.8 g/kg will be given within 12 hours after randomization during hospital admission and then every 4 weeks for 44 weeks (total 48 weeks). Baseline Ig \> or = 7 g/L group - Intravenous immunoglobulin (IVIG) 0.5 g/kg will be given within 12 hours after randomization during hospital admission and then every 4 weeks for 44 weeks (total 48 weeks). |
| Intervention Arm 2: Control | ACTIVE_COMPARATOR | Baseline Ig \< 7g/L group - Normal Saline (0.9% NaCl) 8 mL/kg will be given within 12 hours after randomization during hospital admission and then every 4 weeks for 44 weeks (total 48 weeks). Baseline Ig \> or = 7 g/L group - Normal Saline (0.9% NaCl) 5 mL/kg will be given within 12 hours after randomization during hospital admission and then every 4 weeks for 44 weeks (total 48 weeks). |
| Name | Type | Description |
|---|---|---|
| Intravenous immunoglobulin (IVIG) | DRUG | Baseline Ig \< 7g/L group - Intravenous immunoglobulin (IVIG) 0.8 g/kg will be given within 12 hours after randomization. Baseline Ig \> or = 7 g/L group - Intravenous immunoglobulin (IVIG) 0.5 g/kg will be given within 12 hours after randomization |
| Normal Saline | DRUG | Baseline Ig \< 7g/L group - Normal Saline (0.9% NaCl) 8 mL/kg will be given within 12 hours after randomization. Baseline Ig \> or = 7 g/L group - Normal Saline (0.9% NaCl) 5 mL/kg will be given within 12 hours after randomization |
Inclusion Criteria: * Hospitalized adult patient with AECOPD (clinically dominant AECOPD in the case of multiple co-morbidities eg. absence of overt lobar pneumonia or acute congestive heart failure or alternate diagnosis such as acute coronary syndrome or pulmonary embolism) * Diagnosis of severe ...