Randomized, Controlled Study of IFX-1 in Patients With Severe COVID-19 Pneumonia
Summary
Phase II \& Phase III: This is a pragmatic, adaptive, randomized, multicenter phase II/III study evaluating IFX-1 for the treatment of COVID-19 related severe pneumonia. The study consists of two parts: Phase II, an open-label, randomized, 2-arm phase evaluating best supportive care (BSC) + IFX-1 (Arm A) and BSC alone (Arm B); and Phase III, a double-blind, placebo-controlled, randomized phase comparing standard of care (SOC) + IFX-1 (Arm A) versus SOC + placebo-to-match (Arm B)
Timeline
- Start
- 2020-03-31
- Primary completion
- 2021-10-31
- Completion
- 2021-12-01
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
registry analysis (superiority test); Phase II: IFX-1 + BSC vs Phase II: BSC; p = 0.3677; LS means difference -16.4 (95% CI -53.2 to 20.3) reads as missed primary endpoint NCT04333420 ↗
registry analysis (superiority test); Phase III: IFX-1 + SOC vs Phase III: Placebo + SOC; p = 0.0941; Hazard Ratio (HR) 0.728 (95% CI 0.502 to 1.056); Regression, Cox reads as missed primary endpoint NCT04333420 ↗
release “Relative change in the oxygenation index at day 5 showed no differences between treatment groups.” reads as missed primary endpoint inflarx.de ↗
release “Vilobelimab treatment results in relative reduction in 28-day all-cause mortality of 23.9% compared to placebo (p-value=0.094), but did not show statistical significance” reads as missed primary endpoint inflarx.de ↗
release “Phase III PANAMO trial, which showed that vilobelimab treatment improved survival” reads as met primary endpoint inflarx.de ↗
release “vilobelimab treatment improved survival with a relative reduction in 28-day all-cause mortality of 23.9% compared to placebo” reads as met primary endpoint inflarx.de ↗
release “Vilobelimab in Combination with Tocilizumab or Baricitinib Dramatically Improves Mortality in Critically Ill COVID-19 Patients” reads as met primary endpoint inflarx.de ↗
Publications
- van Amstel RBE, Slim MA, Lim EHT, Ruckinger S, Seymour CW, Burnett BP, Bos LDJ, van Vught LA, Riedemann NC, van de Beek D, Vlaar APJ; PANAMO Study Group. Heterogeneity of treatment effect of vilobelimab in COVID-19: a secondary analysis of a randomised controlled trial. Crit Care. 2024 Jun 28;28(1):210. doi: 10.1186/s13054-024-05004-z.
- Lim EHT, Vlaar APJ, de Bruin S, Ruckinger S, Thielert C, Habel M, Guo R, Burnett BP, Dickinson J, Brouwer MC, Riedemann NC, van de Beek D; PANAMO study group. Pharmacokinetic analysis of vilobelimab, anaphylatoxin C5a and antidrug antibodies in PANAMO: a phase 3 study in critically ill, invasively mechanically ventilated COVID-19 patients. Intensive Care Med Exp. 2023 Jun 19;11(1):37. doi: 10.1186/s40635-023-00520-8.
- Vlaar APJ, Witzenrath M, van Paassen P, Heunks LMA, Mourvillier B, de Bruin S, Lim EHT, Brouwer MC, Tuinman PR, Saraiva JFK, Marx G, Lobo SM, Boldo R, Simon-Campos JA, Cornet AD, Grebenyuk A, Engelbrecht JM, Mukansi M, Jorens PG, Zerbib R, Ruckinger S, Pilz K, Guo R, van de Beek D, Riedemann NC; PANAMO study group. Anti-C5a antibody (vilobelimab) therapy for critically ill, invasively mechanically ventilated patients with COVID-19 (PANAMO): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Respir Med. 2022 Dec;10(12):1137-1146. doi: 10.1016/S2213-2600(22)00297-1. Epub 2022 Sep 7.
- Vlaar APJ, Lim EHT, de Bruin S, Ruckinger S, Pilz K, Brouwer MC, Guo RF, Heunks LMA, Busch MH, van Paassen P, Riedemann NC, van de Beek D. The anti-C5a antibody vilobelimab efficiently inhibits C5a in patients with severe COVID-19. Clin Transl Sci. 2022 Apr;15(4):854-858. doi: 10.1111/cts.13213. Epub 2022 Jan 14.
- Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
- Vlaar APJ, de Bruin S, Busch M, Timmermans SAMEG, van Zeggeren IE, Koning R, Ter Horst L, Bulle EB, van Baarle FEHP, van de Poll MCG, Kemper EM, van der Horst ICC, Schultz MJ, Horn J, Paulus F, Bos LD, Wiersinga WJ, Witzenrath M, Rueckinger S, Pilz K, Brouwer MC, Guo RF, Heunks L, van Paassen P, Riedemann NC, van de Beek D. Anti-C5a antibody IFX-1 (vilobelimab) treatment versus best supportive care for patients with severe COVID-19 (PANAMO): an exploratory, open-label, phase 2 randomised controlled trial. Lancet Rheumatol. 2020 Dec;2(12):e764-e773. doi: 10.1016/S2665-9913(20)30341-6. Epub 2020 Sep 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | vilobelimab | Monoclonal antibody | 800 mg | Intravenous |
Indications
No indication recorded.