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Clinical Trials/ISRCTN21363594
ISRCTN21363594
Completed
未知

A pilot randomized clinical trial of therapeutic plasma exchange (TPE) in serious SARS CoV-2 disease (COVID-19)

King Saud Medical City0 sites87 target enrollmentMay 18, 2020
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ConditionsSerious and life-threatening COVID-19 requiring ICU admissionInfections and InfestationsSARS CoV-2 infection

Overview

Phase
未知
Intervention
Not specified
Conditions
Serious and life-threatening COVID-19 requiring ICU admission
Sponsor
King Saud Medical City
Enrollment
87
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

2020 Protocol article in https://doi.org/10.1186/s13063-020-04454-4 protocol (added 10/06/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33838224/ (added 14/06/2023)

Registry
who.int
Start Date
May 18, 2020
End Date
December 29, 2020
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Aged \=18 years
  • •2\. Admitted to ICU and intubated
  • •3\. Serious COVID\-19 as per World Health Organization and Saudi Centers for Disease Control and Prevention case definition. SARS\-CoV\-2 infection should be confirmed by real\-time polymerase chain reaction (RT\-PCR) assays
  • •4\. At risk of cytokine release syndrome (CRS)

Exclusion Criteria

  • •1\. Previous allergic reaction to plasma exchange reagents (e.g. sodium citrate) or equipment
  • •2\. Two consecutive negative RT\-PCR tests for SARS\-CoV\-2 taken at least 24 h apart
  • •3\. Mild COVID\-19 cases not requiring ICU admission
  • •4\. Terminally ill patients receiving palliative care

Outcomes

Primary Outcomes

Not specified

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