Trial Profile
A Pragmatic Adaptive Randomized, Controlled Phase II/III Multicenter Study of IFX-1 in Patients With Severe COVID-19 Pneumonia
Status:
Completed
Phase of Trial:
Phase II/III
Latest Information Update: 30 Jan 2024
Price :
$35
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At a glance
- Drugs Vilobelimab (Primary) ; Anticoagulants; Dexamethasone; Immunomodulators
- Indications COVID-19 pneumonia
- Focus Registrational; Therapeutic Use
- Acronyms PANAMO
- Sponsors InflaRx
- 12 Sep 2023 Planned number of patients changed from 390 to 430.
- 30 Aug 2023 According to an InflaRx media release, based upon data from this trial ; the Company has submitted a Marketing Authorization Application (MAA) for the treatment of adult patients with SARS-CoV-2 induced septic ARDS receiving IMV or ECMO and that the European Medicines Agency (EMA) has validated the MAA. This means that the application is now under regulatory review by the European CHMP under the centralized procedure, which applies to all 27 member states of the European Union (EU).
- 21 Jun 2023 According to an InflaRx media release, company is continuing discussions with the FDA related to the submission of a Biologics License Application (BLA) for a potential future full approval of Gohibic.