NCT04457349

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
18 days until next milestone

Study Start

First participant enrolled

July 25, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2020

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2021

Completed
Last Updated

April 15, 2022

Status Verified

April 1, 2022

Enrollment Period

5 months

First QC Date

June 30, 2020

Last Update Submit

April 13, 2022

Conditions

COVID 19

Outcome Measures

Primary Outcomes (1)

  • mortality

    Number of patients deaths of the total of patients included

    28 day

Secondary Outcomes (15)

  • the mean time with oxygen therapy

    through study completion, and average of 1 month

  • the mean time with Non-invasive mechanical ventilation

    through study completion, and average of 1 month

  • the mean time of intubation

    through study completion, and average of 1 month

  • respiratory function parameters

    through study completion, and average of 1 month

  • respiratory function parameters

    through study completion, and average of 1 month

  • +10 more secondary outcomes

Study Arms (1)

Therapeutic Plasma Exchange (TPE)

EXPERIMENTAL

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)

Interventions

Therapeutic Plasma Exchange (TPE)PROCEDURE

Treatment with Therapeutic Plasma Exchange (TPE)

Also known as: plasmapheresis
Therapeutic Plasma Exchange (TPE)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Alexandria university, Egypt

Alexandria, 21526, Egypt

Location

Related Publications (13)

  • Chan JF, Yuan S, Kok KH, To KK, Chu H, Yang J, Xing F, Liu J, Yip CC, Poon RW, Tsoi HW, Lo SK, Chan KH, Poon VK, Chan WM, Ip JD, Cai JP, Cheng VC, Chen H, Hui CK, Yuen KY. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. Lancet. 2020 Feb 15;395(10223):514-523. doi: 10.1016/S0140-6736(20)30154-9. Epub 2020 Jan 24.

    PMID: 31986261BACKGROUND

  • Singhal T. A Review of Coronavirus Disease-2019 (COVID-19). Indian J Pediatr. 2020 Apr;87(4):281-286. doi: 10.1007/s12098-020-03263-6. Epub 2020 Mar 13.

    PMID: 32166607BACKGROUND

  • Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.

    PMID: 32007143BACKGROUND

  • Ruan Q, Yang K, Wang W, Jiang L, Song J. Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Med. 2020 May;46(5):846-848. doi: 10.1007/s00134-020-05991-x. Epub 2020 Mar 3. No abstract available.

    PMID: 32125452BACKGROUND

  • Chen G, Wu D, Guo W, Cao Y, Huang D, Wang H, Wang T, Zhang X, Chen H, Yu H, Zhang X, Zhang M, Wu S, Song J, Chen T, Han M, Li S, Luo X, Zhao J, Ning Q. Clinical and immunological features of severe and moderate coronavirus disease 2019. J Clin Invest. 2020 May 1;130(5):2620-2629. doi: 10.1172/JCI137244.

    PMID: 32217835BACKGROUND

  • Sun D, Li H, Lu XX, Xiao H, Ren J, Zhang FR, Liu ZS. Clinical features of severe pediatric patients with coronavirus disease 2019 in Wuhan: a single center's observational study. World J Pediatr. 2020 Jun;16(3):251-259. doi: 10.1007/s12519-020-00354-4. Epub 2020 Mar 19.

    PMID: 32193831BACKGROUND

  • Kalaiyarasu S, Kumar M, Senthil Kumar D, Bhatia S, Dash SK, Bhat S, Khetan RK, Nagarajan S. Highly pathogenic avian influenza H5N1 virus induces cytokine dysregulation with suppressed maturation of chicken monocyte-derived dendritic cells. Microbiol Immunol. 2016 Oct;60(10):687-693. doi: 10.1111/1348-0421.12443.

    PMID: 27730669BACKGROUND

  • Channappanavar R, Perlman S. Pathogenic human coronavirus infections: causes and consequences of cytokine storm and immunopathology. Semin Immunopathol. 2017 Jul;39(5):529-539. doi: 10.1007/s00281-017-0629-x. Epub 2017 May 2.

    PMID: 28466096BACKGROUND

  • Ye Q, Wang B, Mao J. The pathogenesis and treatment of the ;Cytokine Storm' in COVID-19. J Infect. 2020 Jun;80(6):607-613. doi: 10.1016/j.jinf.2020.03.037. Epub 2020 Apr 10.

    PMID: 32283152BACKGROUND

  • Patel P, Nandwani V, Vanchiere J, Conrad SA, Scott LK. Use of therapeutic plasma exchange as a rescue therapy in 2009 pH1N1 influenza A--an associated respiratory failure and hemodynamic shock. Pediatr Crit Care Med. 2011 Mar;12(2):e87-9. doi: 10.1097/PCC.0b013e3181e2a569.

    PMID: 20453703BACKGROUND

  • Adeli SH, Asghari A, Tabarraii R, Shajari R, Afshari S, Kalhor N, Vafaeimanesh J. Therapeutic plasma exchange as a rescue therapy in patients with coronavirus disease 2019: a case series. Pol Arch Intern Med. 2020 May 29;130(5):455-458. doi: 10.20452/pamw.15340. Epub 2020 May 7. No abstract available.

    PMID: 32380821BACKGROUND

  • Zhang L, Zhai H, Ma S, Chen J, Gao Y. Efficacy of therapeutic plasma exchange in severe COVID-19 patients. Br J Haematol. 2020 Aug;190(4):e181-e183. doi: 10.1111/bjh.16890. Epub 2020 Jun 12. No abstract available.

    PMID: 32453903BACKGROUND

  • Bassi E, Park M, Azevedo LC. Therapeutic strategies for high-dose vasopressor-dependent shock. Crit Care Res Pract. 2013;2013:654708. doi: 10.1155/2013/654708. Epub 2013 Sep 15.

    PMID: 24151551BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Plasma ExchangePlasmapheresis

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Blood TransfusionBiological TherapyTherapeuticsBlood Component RemovalSorption DetoxificationExtracorporeal CirculationSurgical Procedures, Operative

Study Officials

  • Mohamed Mamdouh Elsayed, MD

    Lecturer of Nephrology & Internal Medicine, Faculty of Medicine, Alexandria university, Egypt

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

June 30, 2020

First Posted

July 7, 2020

Study Start

July 25, 2020

Primary Completion

December 29, 2020

Study Completion

January 20, 2021

Last Updated

April 15, 2022

Record last verified: 2022-04

Locations

EG(1)