Therapeutic plasma exchange (removal of the non-cell portion of blood) in critically ill adult patients with serious SARS CoV-2 disease (COVID-19)

Not Applicable

Completed

• Conditions: Serious and life-threatening COVID-19 requiring ICU admission; Infections and Infestations; SARS CoV-2 infection

• Registration Number: ISRCTN21363594
• Lead Sponsor: King Saud Medical City

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-18
• Study Completion: 2020-12-29
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 87

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. 28-day mortality assessed using patient medical records <br>2. Safety assessed by measuring adverse events and serious adverse events collected as usual for TPE treatment using the Saudi FDA reporting standard during the TPE session and the following 48 h

Secondary Outcome Measures

Name	Time	Method
1. Organ function assessed using Sequential Organ Function Assessment (SOFA) score before and after each TPE session<br>2. Inflammation markers (including lymphocyte counts, C-reactive protein [CRP], lactate dehydrogenase [LDH], ferritin, D-dimer, interleukin-6 [IL-6]) measured using usual hospital laboratory assays before and after each TPE session<br>3. Days on mechanical ventilation assessed using patient medical records <br>4. ICU length of stay assessed using patient medical records