Investigational Treatments for COVID-19 in Tertiary Care Hospital of Pakistan
Covid19, Cytokine Release Syndrome, Critical Illness
About this trial
This is an interventional treatment trial for Covid19 focused on measuring Therapeutic Plasma exchange, tocilizumab, remdesivir, convalescent plasma, mesenchymal stem cell, COVID-19, investigational treatment
Eligibility Criteria
Inclusion Criteria:
- PCR positive confirmed COVID-19
- Admitted in hospital
- willing patients to participate in trial
- Day of illness less than 14 days
- no contraindications to invasive procedure or novel therapies
Exclusion Criteria:
- co morbidities with life expectancy less than 6 months
- Multi organ failure
- Septic shock before initiation of treatment
- 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
Sites / Locations
- Pak Emirates Military Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
No Intervention
Experimental
Experimental
Experimental
Supportive Arm
TPE arm
TPE in combination with other investigational treatments
Either alone or combination of MSC, Remdesivir and Tocilizumab
As per Institutional COVID-19 Management Guidelines all patients of moderate, severe and critical COVID-19 received standard protocol of aspirin, anticoagulation, ulcer prophylaxis, awake Proning (if PaO2 < 80mmHg) and corticosteroids. All patients of Cytokine release storm (CRS) received either Methylprednisolone 1 mg/kg or Dexamethasone 6-12mg/day irrespective of disease severity.
addition to standard care TPE will be performed once daily using COBE Spectra Apheresis machine version 7 (Manufacturer TERUMO BCT, Lakewood, CO, USA INC) having continuous flow centrifugation. Venous access will be achieved using an ultrasound guided double lumen catheter (Arrow - 12 FR) via femoral vein. Patient's total blood volume will be calculated as per Nadler's formula. Anticoagulant acid dextrose ratio will be 1:10 and flow rate 30-40 ml/minutes (Adjusted as per hemodynamic status). Patients' blood pressure, pulse, oxygen saturation will be monitored throughout procedure. Duration of procedure varied from 2-4 hours and 1-1.5 times total plasma volume will be removed during each procedure. Replacement fluid will be fresh frozen plasma (FFP) and normal saline in 2:1 respectively. All procedures will be performed in intensive care or high dependency unit by Apheresis Department of PEMH. TPE will be continued till recovery.
During TPE, Replacement fluid will be fresh frozen plasma (FFP) and normal saline in 2:1 respectively plus 200-400 ml of convalescent plasma. A predefined number of patients will also receive mesenchymal stem cell therapy and/or Remdesivir
A predefined number of patients will receive either alone Tocilizumab, Remdesivir and Mesenchymal stem cell therapy or their combination