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Article History

Received: 4 March 2024

Accepted: 3 December 2024

First Online: 18 December 2024

Declarations

:

: The study was approved by the institutional review boards or ethics committees for each site and conducted in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki of 1975. The study protocol (Reference 9; appendix pp 39–250) was approved by an institutional review board (Amsterdam UMC, Amsterdam, Netherlands; IRB 2020_067#B2020179, Study Title: A Pragmatic Adaptive Randomized Controlled Phase II/III Multicenter Study of IFX-1 in Patients with Severe COVID-19 Pneumonia—“PANAMO”). All patients or their legally authorized representatives provided written informed consent. In the Netherlands, Germany, and Russia, deferred consent procedures were allowed. Deferred consent involved randomization at investigators discretion according to pre-set criteria agreed on during ethical review of the protocol, followed by the request for patient’s (deferred patient consent) or representative’s (deferred proxy consent) informed consent during the study [Jansen TC, Kompanje EJO, Druml C, et al.: Deferred consent in emergency intensive care research: what if the patient dies early? Use the data or not? Intensive Care Med 2007; 33:894–900].

: Not applicable.

: PHKS has acted as a statistical consultant for InflaRx GmbH.