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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN21363594

Enrollment

Registered

2020-05-18

Start date

2020-05-01

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

The researchers aim to conduct a pilot prospective design of 6 to 12 months duration regarding the use of therapeutic plasma exchange (TPE) in serious COVID-19. The study will be multicenter. Adult IC

hence, no enrollment concealment will be expedited. However, the lack of allocation concealment will be mitigated as much as possible by the following measures.

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
1. 28-day mortality assessed using patient medical records 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

Measure	Time frame
1. Organ function assessed using Sequential Organ Function Assessment (SOFA) score before and after each TPE session 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 3. Days on mechanical ventilation assessed using patient medical records 4. ICU length of stay assessed using patient medical records	—

Measure

Time frame

1. Organ function assessed using Sequential Organ Function Assessment (SOFA) score before and after each TPE session 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 3. Days on mechanical ventilation assessed using patient medical records 4. ICU length of stay assessed using patient medical records

—

Countries

Oman, Saudi Arabia, United Arab Emirates

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 27, 2026