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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04675931 | To Evaluate Efficacy, Safety, Tolerability and PK of Intravenous Cipargamin in Participants With Severe Plasmodium Falciparum Malaria | PHASE2 | COMPLETED | 254 | — | — | Mar 7, 2022 | Aug 20, 2025 | Apr 9, 2026 | 9 | Burkina Faso, Côte d’Ivoire +5 |
A blood draw was performed at each collection time point for parasitemia assessment.
| Arm | Type | Description |
|---|---|---|
| IV Cipargamin 20 mg | EXPERIMENTAL | Participants received intravenous cipargamin 20 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days). |
| IV Cipargamin 40 mg | EXPERIMENTAL | Participants received intravenous cipargamin 40 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days). |
| IV Artesunate | ACTIVE_COMPARATOR | Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days). |
| Name | Type | Description |
|---|---|---|
| Cipargamin | DRUG | Cipargamin, 20 mg or 40 mg, by intravenous administration of solution for injection |
| IV Artesunate | DRUG | Artesunate, 2.4 mg/kg or 3 mg/kg, by intravenous administration of reconstituted solution |
| Coartem | DRUG | Oral standard of care (Coartem tablets, dosed per weight, as per label) |
Inclusion Criteria: * Cohort 1: Participants aged ≥ 12 years with moderately severe malaria as defined in (prostration and/or repeated vomiting) without presence of other signs of severe malaria (and with high P. falciparum parasitemia (60,000-250,000 parasites per µl) * Subsequent Cohorts 2 to ...