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Therapeutic Plasma Exchange in Resistant Cytokine Storm of COVID 19

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ClinicalTrials.gov Identifier: NCT04457349
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD, Alexandria University

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.

Condition or disease Intervention/treatment Phase
COVID 19 Procedure: Therapeutic Plasma Exchange (TPE) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does Therapeutic Plasma Exchange Have A Role in Resistant Cytokine Storm State Of COVID-19 Infection?
Actual Study Start Date : July 25, 2020
Actual Primary Completion Date : December 29, 2020
Estimated Study Completion Date : January 20, 2021

Arm Intervention/treatment
Experimental: Therapeutic Plasma Exchange (TPE)
Each patient will undergo two sessions. TPE will be done through filtration technique using a plasma filter at a dose of (1-1.5) plasma volume/session. Fresh frozen plasma or albumin 5% will be used to replace plasma.
Procedure: Therapeutic Plasma Exchange (TPE)
Treatment with Therapeutic Plasma Exchange (TPE)
Other Name: plasmapheresis




Primary Outcome Measures :
  1. mortality [ Time Frame: 28 day ]
    Number of patients deaths of the total of patients included


Secondary Outcome Measures :
  1. the mean time with oxygen therapy [ Time Frame: through study completion, and average of 1 month ]
    to calculate the mean time with oxygen therapy

  2. the mean time with Non-invasive mechanical ventilation [ Time Frame: through study completion, and average of 1 month ]
    to calculate the mean time with Non-invasive mechanical ventilation

  3. the mean time of intubation [ Time Frame: through study completion, and average of 1 month ]
    to calculate the mean time of intubation

  4. respiratory function parameters [ Time Frame: through study completion, and average of 1 month ]
    To calculate the mean of PaO2/FiO2

  5. respiratory function parameters [ Time Frame: through study completion, and average of 1 month ]
    To calculate the mean of levels of oxygen saturation

  6. radiological lung extension [ Time Frame: through study completion, and average of 1 month ]
    to evaluate the lung extension of pneumonia

  7. mean duration of hospitalization and ICU use [ Time Frame: through study completion, and average of 1 month ]
    Days of hospitalization in survivors and/or days at ICU throughout the study

  8. the requirement of additional organ support [ Time Frame: through study completion, and average of 1 month ]
    Percentage of patients with dialysis

  9. the levels of IL-6 [ Time Frame: through study completion, and average of 1 month ]
    To evaluate the effect of TPE on the serum levels of inflammatory markers

  10. Incidence of adverse events [ Time Frame: through study completion, and average of 1 month ]
    To calculate the number of adverse events in patients with COVID-19 treated with TPE

  11. time to reverse-transcriptase polymerase chain reaction (RT-PCR) virus negativity [ Time Frame: through study completion, and average of 1 month ]
    To evaluate the time to RT-PCR virus negativity

  12. the levels of CRP [ Time Frame: through study completion, and average of 1 month ]
    To evaluate the effect of TPE on the serum levels of inflammatory markers

  13. the levels of procalcitonin (PCT) [ Time Frame: through study completion, and average of 1 month ]
    To evaluate the effect of TPE on the serum levels of inflammatory markers

  14. levels of D-dimer [ Time Frame: through study completion, and average of 1 month ]
    To evaluate the effect of TPE on the serum levels of inflammatory markers

  15. levels of ferritin [ Time Frame: through study completion, and average of 1 month ]
    To evaluate the effect of TPE on the serum levels of inflammatory markers



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

      1. Persistent high IL-6 and CRP.
      2. Persistent worsening of respiratory symptoms ( dyspnea, tachypnea, increased oxygen (O2) requirements or even need for mechanical ventilation).
      3. Partial arterial pressure of oxygen to fractional inspired concentration of oxygen (PaO2/FiO2) ratio < 150.
      4. Persistent fever (˃38.5°C) despite normal procalcitonin level.

Exclusion Criteria:

  • 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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04457349


Contacts
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Contact: Mohamed Mamdouh Elsayed, MD 00201068055103 dr_mohamedmamdouh87@yahoo.com
Contact: Ayman I Baess, MD 00201006822068 Ayman.baeis@yahoo.com

Locations
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Egypt
Faculty of Medicine, Alexandria university, Egypt Recruiting
Alexandria, Egypt, 21526
Contact: Mohamed Mamdouh Elsayed, MD    00201068055103    dr_mohamedmamdouh87@yahoo.com   
Sponsors and Collaborators
Alexandria University
Investigators
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Principal Investigator: Mohamed Mamdouh Elsayed, MD Lecturer of Nephrology & Internal Medicine, Faculty of Medicine, Alexandria university, Egypt
Study Chair: montasser M zeid, MD Professor of Nephrology & Internal Medicine, Faculty of Medicine, Alexandria university, Egypt
Study Chair: Akram M Fayed, MD Professor of Critical Care Medicine, Faculty of Medicine, Alexandria university, Egypt
Study Chair: Ehab M El Reweny, MD Assistant Professor of Critical Care Medicine, Faculty of Medicine, Alexandria university, Egypt
Study Chair: Nermine H Zakaria, MD Professor of Clinical and Chemical Pathology Medicine, Faculty of Medicine, Alexandria university, Egypt
Study Chair: Ayman I Baess, MD Assistant Professor of Chest Diseases, Faculty of Medicine, Alexandria university, Egypt
Publications:

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Responsible Party: Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD, lecturer, Alexandria University
ClinicalTrials.gov Identifier: NCT04457349    
Other Study ID Numbers: plasma exchange in COVID 19
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No