Therapeutic Plasma Exchange for Coronavirus Disease-2019 Triggered Cytokine Release Storm; (Plex)
COVID-19, Cytokine Release Syndrome
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Therapeutic Plasma exchange, Cytokine release storm, COVID-19, ARDS, Critical disease
Eligibility Criteria
Inclusion Criteria:
- COVID-19 diagnosed by Polymerase Chain Reaction (PCR) positivity for SARS-CoV2
- CRS at presentation or developing during hospitalization
- 10-80 years age and both genders
- hospital admission
- At least 1 completed session of plasma-exchange in patients included in TPE arm
- No other novel therapy administered.
Exclusion criteria were:
- Death within 48 hours of admission
- severe septic shock at time of admission
- Congestive cardiac failure (EF<20%) (4)
- Those receiving immunotherapy, Anti-thymocyte globulin or hematopoietic stem cell transplant in recent past
- Patients of hematological or solid organ malignancies
- patients receiving other investigational drugs including Tocilizumab, Convalescent plasma, Remdesivir, or Mesenchymal stem cells.
Sites / Locations
- Pak Emirates Military Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
TPE Arm
NON TPE arm
In addition to standard care TPE was performed once daily using COBE Spectra Apheresis machine version 7 (Manufacturer TERUMO BCT, Lakewood, CO, USA INC) having continuous flow centrifugation. Venous access was achieved using an ultrasound guided double lumen catheter (Arrow - 12 FR) via femoral vein. Patient's total blood volume was calculated as per Nadler's formula. Anticoagulant acid dextrose ratio was 1:10 and flow rate 30-40 ml/minutes (Adjusted as per hemodynamic status). Patients' blood pressure, pulse, oxygen saturation was monitored throughout procedure. Duration of procedure varied from 2-4 hours and 1-1.5 times total plasma volume was removed during each procedure. Replacement fluid was fresh frozen plasma (FFP) and normal saline in 2:1 respectively. All procedures were performed in intensive care or high dependency unit by Apheresis Department of PEMH. TPE was continued till recovery
Only supportive treatment offered including Vit C, Zinc, Vit D, famotidine, Enoxaparin and Methylprednisolone