Status:
COMPLETED
Therapeutic Plasma Exchange for Coronavirus Disease-2019 Triggered Cytokine Release Storm;
Lead Sponsor:
UNICEF
Collaborating Sponsors:
Pak Emirates Military Hospital Rawalpindi
Conditions:
COVID-19
Cytokine Release Syndrome
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Background: investigators have seen recently from experience in Western countries with best health care systems that pandemics cannot be managed in hospitals. Investigators have seen ICUs crowded to ...
Detailed Description
PROTOCOL SUMMARY: Therapeutic plasma exchange for coronavirus disease-2019 triggered cytokine release storm; a retrospective propensity matched control study Clinical Phase: Two arms, Phase 2 Open L...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2020
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT04485169
Start Date
April 1 2020
End Date
July 31 2020
Last Update
September 28 2020
Active Locations (1)
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1
Pak Emirates Military Hospital
Rawalpindi, Punjab Province, Pakistan, 46000