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)
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1
Faculty of Medicine, Alexandria university, Egypt
Alexandria, Egypt, 21526