COVID-19 trials registries data warehouse

https://www.isrctn.com/ISRCTN21363594

Fahad Faqihi

dr.faqihi677@gmail.com

2020-05-18

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

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)

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

2

King Saud Medical City

18

100

Oman;Saudi Arabia;United Arab Emirates

Critical disease at enrollment

8: Critical disease at enrollment

80

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

Not reported

[{"arm_notes": "", "treatment_id": 1000, "treatment_name": "Plasma exchange", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]