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Randomised controlled trial of intravenous nafamostat mesylate in COVID pneumonitis: Phase 1b/2a experimental study to investigate safety, Pharmacokinetics and Pharmacodynamics by Tom M. Quinn; Erin E. Gaughan; Annya Bruce; Jean Antonelli; Richard O'Connor; Feng Li; Sarah McNamara; Oliver Koch; Claire MacKintosh; David Dockrell; Timothy Walsh; Kevin G. Blyth; Colin Church; Jürgen Schwarze; Cecilia Boz; Asta Valanciute; Matthew Burgess; Philip Emanuel; Bethany Mills; Giulia Rinaldi; Gareth Hardisty; Ross Mills; Emily Gwyer Findlay; Sunny Jabbal; Andrew Duncan; Sinéad Plant; Adam D.L. Marshall; Irene Young; Kay Russell; Emma Scholefield; Alastair F. Nimmo; Islom B. Nazarov; Grant C. Churchill; James S.O. McCullagh; Kourosh H. Ebrahimi; Colin Ferrett; Kate Templeton; Steve Rannard; Andrew Owen; Anne Moore; Keith Finlayson; Manu Shankar-Hari; John Norrie; Richard A. Parker; Ahsan R. Akram; Daniel C. Anthony; James W. Dear; Nik Hirani; Kevin Dhaliwal is a Medicine article available to read on EtoBox.

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## Summary ## Background Many repurposed drugs have progressed rapidly to Phase 2 and 3 trials in COVID19 without characterisation of Pharmacokinetics /Pharmacodynamics including safety data. One such drug is nafamostat mesylate. ## Methods We present the findings of a phase Ib/IIa open label, platform randomised controlled trial of intravenous nafamostat in hospitalised patients with confirmed COVID-19 pneumonitis. Patients were assigned randomly to standard of care (SoC), nafamostat or an alternative therapy. Nafamostat was administered as an intravenous infusion at a dose of 0.2 mg/kg/h for a maximum of seven days. The analysis population included those who received any dose of the trial drug and all patients randomised to SoC. The primary outcomes of our trial were the safety and tolerability of intravenous nafamostat as an add on therapy for patients hospitalised with COVID-19 pneumonitis. ## Findings Data is reported from 42 patients, 21 of which were randomly assigned to receive intravenous nafamostat. 86% of nafamostat-treated patients experienced at least one AE compared to 57% of the SoC group. The nafamostat group were significantly more likely to experience at least one

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Author

Tom M. Quinn; Erin E. Gaughan; Annya Bruce; Jean Antonelli; Richard O'Connor; Feng Li; Sarah McNamara; Oliver Koch; Claire MacKintosh; David Dockrell; Timothy Walsh; Kevin G. Blyth; Colin Church; Jürgen Schwarze; Cecilia Boz; Asta Valanciute; Matthew Burgess; Philip Emanuel; Bethany Mills; Giulia Rinaldi; Gareth Hardisty; Ross Mills; Emily Gwyer Findlay; Sunny Jabbal; Andrew Duncan; Sinéad Plant; Adam D.L. Marshall; Irene Young; Kay Russell; Emma Scholefield; Alastair F. Nimmo; Islom B. Nazarov; Grant C. Churchill; James S.O. McCullagh; Kourosh H. Ebrahimi; Colin Ferrett; Kate Templeton; Steve Rannard; Andrew Owen; Anne Moore; Keith Finlayson; Manu Shankar-Hari; John Norrie; Richard A. Parker; Ahsan R. Akram; Daniel C. Anthony; James W. Dear; Nik Hirani; Kevin Dhaliwal

Publisher

Elsevier BV

Published

2022

Language

EN

Field

Medicine (Life Sciences)