Randomized, Controlled Study of IFX-1 in Patients With Severe COVID-19 Pneumonia
NCT ID: NCT04333420
Last Updated: 2023-06-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
399 participants
INTERVENTIONAL
2020-03-31
2021-12-01
Brief Summary
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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)
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Detailed Description
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1st patient was enrolled in the phase III portion on 1st October 2020.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Phase II: IFX-1 + BSC
Phase II study part: IFX-1: 800mg intravenously administered, BSC: Best supportive care
IFX-1 + BSC
Phase II study part: IFX-1 + BSC
Phase II: BSC
Phase II study part: BSC: Best supportive care
BSC
Phase II study part: BSC
Phase III: IFX-1 + SOC
Phase III study part: IFX-1: 800mg intravenously administered, SOC: Standard of care
IFX-1 + SOC
Phase III study part: IFX-1 + SOC
Phase III: Placebo + SOC
Phase III study part: Placebo: placebo infusion intravenously administered, SOC: Standard of care
Placebo + SOC
Phase III study part: Placebo + SOC
Interventions
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IFX-1 + BSC
Phase II study part: IFX-1 + BSC
BSC
Phase II study part: BSC
IFX-1 + SOC
Phase III study part: IFX-1 + SOC
Placebo + SOC
Phase III study part: Placebo + SOC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinically evident or otherwise confirmed severe pneumonia
* SARS-CoV-2 infection confirmation (tested positive in last 14 days before randomization with locally available test system)
* At least 18 years of age or older
* Patient on invasive mechanical ventilation (but not more than 48h post intubation at time point of first IMP administration)
* Patients with a PaO2 / FiO2 ratio of \< 200 and \> 60 at randomization (one representative measurement within 6h before randomization)
* SARS-CoV-2 infection confirmation (tested positive in last 14 days before randomization with locally available test system)
Exclusion Criteria
* Patient moribund or expected to die in next 24h according to the judgment of the investigator
* Known severe congestive heart failure (New York Heart Association \[NYHA\] Class III- IV)
* Received organ or bone marrow transplantation in past 3 months
* Known cardio-pulmonary mechanical resuscitation in past 14 days
Phase III:
* Intubated \> 48 h at time point of first IMP administration
* Expected stop of invasive ventilation or expected extubation in the next 24h without additional intervention according to judgment of the investigator
* Known history of chronic dialysis OR received renal replacement therapy in past 14 days OR anticipated to receive renal replacement therapy within 24h after randomization
* Known history of progressed COPD as evidenced by use of daily maintenance treatment with long-acting bronchodilators or inhaled/oral corticosteroids for \> 2 months
* Treatment of COVID-19 with investigational antibody treatment(s) which are not approved or not included in locally adopted treatment guidelines (e.g., WHO guidance, National Institutes of Health \[NIH\] COVID-19 treatment guidelines) for this indication in the past 7 days (Note: Antibody treatment\[s\] given within past 7 days for pre-existing diseases, other than COVID-19, are allowed.)
* At time point of randomization, treatment of COVID-19 with investigational treatments which are not approved or not included in locally adopted treatment guidelines for this indication (e.g., WHO guidance, NIH COVID-19 treatment guidelines), including SARS-CoV-2 multiplication inhibitor(s) or immunomodulator(s). (Note: If a locally adopted treatment guideline recommends drugs such as remdesivir, dexamethasone, or anticoagulation, this would be allowed. Adopted guidelines and updates must be documented at study initiation and throughout the conduct of the study.)
* Received cytokine adsorption therapy in past 3 days
* Known severe congestive heart failure (corresponding to e.g. NYHA Class III-IV, left ventricular ejection fraction \<40%)
* Known history of chronic liver disease (Child-Pugh B or C)
18 Years
ALL
No
Sponsors
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InflaRx GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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A Vlaar, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Amsterdam
Locations
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InflaRx Site #1107
Aalst, , Belgium
InflaRx Site #1102
Brussels, , Belgium
InflaRx Site #1104
Leuven, , Belgium
InflaRx Site #1106
Lodelinsart, , Belgium
InflaRx Site #1101
Yvoir, , Belgium
InflaRx Site #0301
Belo Horizonte, , Brazil
InflaRx Site #0302
Campinas, , Brazil
InflaRx Site #0305
Criciúma, , Brazil
InflaRx Site #0308
Curitiba, , Brazil
InflaRx Site #0304
Porto Alegre, , Brazil
InflaRx Site #0303
São José, , Brazil
InflaRx Site #0306
São Paulo, , Brazil
InflaRx Site #1011
Grenoble, , France
InflaRx Site #1005
Nantes, , France
InflaRx Site #1009
Nantes, , France
InflaRx Site #1003
Nice, , France
InflaRx Site #1001
Paris, , France
InflaRx Site #1004
Paris, , France
InflaRx Site #1006
Paris, , France
InflaRx Site #1008
Paris, , France
InflaRx Site #1012
Saint-Etienne, , France
InflaRx Site #1002
Suresnes, , France
InflaRx Site #0201
Aachen, , Germany
InflaRx Site #0207
Augsburg, , Germany
InflaRx Site #0202
Berlin, , Germany
InflaRx Site #0208
Dresden, , Germany
InflaRx Site #0204
Essen, , Germany
InflaRx Site #0203
Greifswald, , Germany
InflaRx Site #0205
Hanover, , Germany
InflaRx Site #0206
Jena, , Germany
InflaRx Site #0502
Chihuahua City, , Mexico
InflaRx Site #0503
Culiacán, , Mexico
InflaRx Site #0506
Mérida, , Mexico
InflaRx Site #0504
Monterrey, , Mexico
InflaRx Site #0501
Nuevo León, , Mexico
InflaRx Site #0505
Veracruz, , Mexico
InflaRx Site #0101
Amsterdam, , Netherlands
InflaRx Site #0103
Amsterdam, , Netherlands
InflaRx Site #0106
Eindhoven, , Netherlands
InflaRx Site #0104
Enschede, , Netherlands
InflaRx Site #0102
Maastricht, , Netherlands
InflaRx Site #0601
Callao, , Peru
InflaRx Site #0603
Lima, , Peru
InflaRx Site #0604
Lima, , Peru
InflaRx Site #0701
Barnaul, , Russia
InflaRx Site #0704
Moscow, , Russia
InflaRx Site #0702
Ryazan, , Russia
InflaRx Site # 0804
Somerset West, , South Africa
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2020-001335-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IFX-1-P2.9
Identifier Type: -
Identifier Source: org_study_id
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