4 completed, 1 recruiting, 1 terminated. 3 Phase 2, 3 Phase 3, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 3 | Completed 2, Terminated 1 |
| Phase 3 | 3 | Completed 1, Recruiting 1, Terminated 1 |
| Phase 1 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Efficacy of INM004 in Children With STEC-HUS INM004, Placebo - Hemolytic-Uremic Syndrome | Phase 3 | Recruiting | Inmunova S.A. | 220 | 2024-10-05 | 2026-01-15 |
| A Study to Assess Safety, Efficacy, and Pharmacokinetics of INM004 in Pediatric Patients With STEC-HUS INM004, SoC - Diarrhea-Associated Hemolytic Uremic Syndrome, Pediatric Kidney Disease | Phase 2 | Completed | Inmunova S.A. | 57 | 2022-10-06 | 2023-08-21 |
| Effectiveness and Safety Study of Specific Hyperimmune Equine Serum for the Treatment of Severe Hospitalized SARS-CoV-2 in Adults: Retrospective Cohort Study Covid19 | Completed | Inmunova S.A. | 847 | 2021-05-22 | 2022-04-06 | |
| A Study to Investigate the Pharmacokinetics, Efficacy and Safety of INM005 in Patients With COVID-19. INM005, Placebo - COVID-19 | Phase 2 / Phase 3 | Completed | Inmunova S.A. | 243 | 2020-07-27 | 2026-04-20 |
| Phase 2/3 Study to Evaluate PK, Safety & Efficacy of INM004 in STEC Positive Pediatric Patients for Prevention of HUS INM004, Placebo - Bloody Diarrhea, STEC, Unspecified | Phase 2 / Phase 3 | Terminated | Inmunova S.A. | 11 | 2019-07-17 | 2023-07-19 |
| Anti-Shiga Toxin Hyperimmune Equine Immunoglobulin F(ab')2 Fragment (INM004) in Healthy Volunteers Drug: INM004 Dose 1, Drug: INM004 Dose 2, Drug: INM004- Repeated dose - Healthy Volunteers | Phase 1 | Completed | Inmunova S.A. | 14 | 2017-12-16 | 2019-02-27 |
Hemolytic-Uremic Syndrome (3) · COVID-19 (2)
Exercise (2)
Argentina (6) · Belgium (1) · France (1) · Germany (1) · Ireland (1) · Italy (1) · Romania (1) · Spain (1) · United Kingdom (1)
Santiago Sanguineti, Ph.D (2) · Fernando Goldbaum, PhD (1) · Mariana Colonna, Bioch (1) · Santiago Sanguineti, Ph.D. (1)
PMID 33870149, PMID 34013969, PMID 34219224, PMID 34473343, PMID 40277027, PMID 41757982