Indications
Sepsis (see Sepsis)
Clinical Efficacy
- SCIENS Study of Vilobelimab in Sepsis (Crit Care Explor, 2021) [MEDLINE]
- Administration of vilobelimab in patients with severe sepsis and septic shock selectively neutralizes C5a in a dose-dependent manner without blocking formation of the membrane attack complex and without resulting in detected safety issues
- The data warrant further investigation of C5a inhibition in sepsis
- Efficacy and Safety of Vilobelimab (IFX-1), a Novel Monoclonal Anti-C5a Antibody, in Patients With Early Severe Sepsis or Septic Shock-A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase IIa Trial (SCIENS Study). Crit Care Explor. 2021 Nov 17;3(11):e0577. doi: 10.1097/CCE.0000000000000577. eCollection 2021 Nov [MEDLINE]
Severe Acute Respiratory Syndrome Coronavirus-2 (SARS CoV-2, COVID-19) (see Severe Acute Respiratory Syndrome Coronavirus-2)
- Phase 3 PANAMO Trial of Vilobelimab in Critically Ill, Invasively Mechanically Ventilated Patients with COVID-19 (Lancet Respir Med, 2022) [MEDLINE]
- Randomized, double-blind, placebo-controlled, multicentre phase 3 trial was performed at 46 hospitals in the Netherlands, Germany, France, Belgium, Russia, Brazil, Peru, Mexico, and South Africa
- In addition to standard of care, vilobelimab improves survival of invasive mechanically ventilated patients with COVID-19 and leads to a significant decrease in mortality
- Vilobelimab could be considered as an additional therapy for patients in this setting and further research is needed on the role of vilobelimab and C5a in other acute respiratory distress syndrome-causing viral infections
Pharmacology
Monoclonal Anti-C5a Antibody
- xxx
Metabolism
- xxx
Administration
XXXXX
- xxx
Dose Adjustment
- Hepatic: xxx
- Renal: xxx
Use in Pregnancy (see Pregnancy)
- xxx
Use During Breast Feeding
- xxx
Adverse Effects
Other Adverse Effects
- xxx
- xxx
- xxx
- xxx
References
Indications
- Efficacy and Safety of Vilobelimab (IFX-1), a Novel Monoclonal Anti-C5a Antibody, in Patients With Early Severe Sepsis or Septic Shock-A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase IIa Trial (SCIENS Study). Crit Care Explor. 2021 Nov 17;3(11):e0577. doi: 10.1097/CCE.0000000000000577. eCollection 2021 Nov [MEDLINE]