NCT04352985

Evaluating the Use of Polymyxin B Cartridge Hemoperfusion for Patients With Septic Shock and COVID 19

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Spectral Diagnostics (US) Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

Prospective, observational, clinical investigation of PMX cartridge use in COVID 19 patients with septic shock

Detailed description

This is a compassionate use protocol for a population of patients with an immediately life-threatening condition, for whom no comparable alternative therapy options are available. The PMX cartridge will be utilized to treat critically ill patients with septic shock who also have COVID 19 virus. The objective will be to observe the efficacy of the PMX cartridge with a focus on safety of use in this population.

Conditions

• Septic Shock
• Endotoxemia
• COVID
• Corona Virus Infection
• Sepsis, Severe

Interventions

Type	Name	Description
DEVICE	Toraymyxin PMX-20R (PMX Cartridge)	The intervention is two (2) treatment sessions of PMX cartridge administration within approximately 24 hours of each other. Each treatment session will target 2 hours with a minimum of 1 ½ hours, at a flow rate of approximately 100 mL/minute, (range of 80 to 120 mL/minute). In cases where the clinical status of the subject is improving, or if the subject suffers from a relapse and the treating physician believes an additional PMX treatment may improve the clinical outcome of the subject, they may administer an additional PMX treatment session (for a total of 3 treatment sessions) at their discretion. All subjects will continue to receive standard medical care for COVID 19 and septic shock.

Timeline

• First posted: 2020-04-20
• Last updated: 2021-09-20

Locations

3 sites across 1 country: United States