Therapeutic Plasma Exchange Followed by Convalescent Plasma Transfusion in Severe and Critically Ill COVID-19 Patients

Novacescu Alexandru

Status: Completed

Conditions: COVID-19 Respiratory Infection; COVID-19 Pneumonia; Acute Respiratory Distress Syndrome; Acute Respiratory Failure

Treatments: Other: Therapeutic plasma exchange

Study type: Interventional

Funder types: Other

Identifiers

NCT04973488

STUDYTPECVP20

Details and patient eligibility

About

Therapeutic plasma exchange (TPE) has been proposed as a rescue therapy in critically ill COVID-19 patients. The aim of this study is to determine whether combining TPE with convalescent plasma (CVP) transfusion early during the intensive care unit (ICU) stay, improves survival among this heterogeneous population.

Full description

This single centre prospective, non-randomised controlled trial will be conducted in an 8 bed COVID-19 ICU and will include patients with severe COVID-19 pneumonia requiring ICU monitoring and therapy. 19 patients will be treated performing TPE followed by CVP transfusion while for 19 patients will receive standard treatment according to hospital protocols. TPE will be initiated during the first 24 hours after ICU admission, followed immediately by transfusion of CVP. The primary endpoint is survival at 30 days. Secondary endpoints include assessing the evolution of biomarkers, such as the partial pressure of arterial oxygen (PaO2) to fractional inspired oxygen (FiO2) ratio (P/F ratio), C reactive protein (CRP), lactate dehydrogenase (LDH) and ferritin at the 7-day follow-up.

Enrollment: 38 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• positive reverse transcriptase PCR test for COVID 19
• COVID-19 pneumonia
• All patients included were adults (>18 years)
• Acute respiratory failure

Exclusion criteria

• pregnant women
• patients with suspected or confirmed pulmonary embolism
• patients with terminal disease

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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38 participants in 2 patient groups

Treatment arm

Experimental group

Description:

In the treatment arm, Therapeutic plasma exchange will be conducted in the first 24 hours after being admitted into the intensive care unit, after which convalescent plasma from donors that have had COVID-19 will be transfused

Treatment:

Other: Therapeutic plasma exchange

Control arm

No Intervention group

Description:

In the control arm, patients will receive standard COVID-19 treatment