Status:

COMPLETED

Therapeutic Plasma Exchange in Resistant Cytokine Storm of COVID 19

Lead Sponsor:

Alexandria University

Conditions:

COVID 19

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

This research is planned to illustrate the efficacy of Therapeutic Plasma Exchange (TPE) treatment in COVID-19 patients with resistant cytokine storm state.

Detailed Description

In early December 2019, several pneumonia cases of unknown origin were observed in Wuhan (China). A novel enveloped RNA β coronavirus was isolated and named severe acute respiratory syndrome coronavir...

Eligibility Criteria

Inclusion

  • COVID-19 positive patients (confirmed by PCR) with cytokine storm state who will not improve after two doses of tocilizumab.
  • Criteria of failure (resistance) to tocilizumab:
  • Persistent high IL-6 and CRP.
  • Persistent worsening of respiratory symptoms ( dyspnea, tachypnea, increased oxygen (O2) requirements or even need for mechanical ventilation).
  • Partial arterial pressure of oxygen to fractional inspired concentration of oxygen (PaO2/FiO2) ratio \< 150.
  • Persistent fever (˃38.5°C) despite normal procalcitonin level.

Exclusion

  • Refractory septic shock:
  • ( It is defined according to surviving sepsis campaign as the presence of hypotension with end organ dysfunction requiring high dose vasopressor support often greater than 0.5 µg/kg/min norepinephrine or equivalent).

Key Trial Info

Start Date :

July 25 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 20 2021

Estimated Enrollment :

10 Patients enrolled

Trial Details

Trial ID

NCT04457349

Start Date

July 25 2020

End Date

January 20 2021

Last Update

April 15 2022

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Faculty of Medicine, Alexandria university, Egypt

Alexandria, Egypt, 21526