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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed 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.

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

Conditions
-----------------
Acute Respiratory Failure, Acute Respiratory Distress Syndrome, COVID-19 Pneumonia, COVID-19 Respiratory Infection

Intervention / Treatment
-----------------
* Other: Therapeutic plasma exchange


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: positive reverse transcriptase PCR test for COVID 19 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single group, that is divided into two arms
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment arm<br>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 | Other: Therapeutic plasma exchange<br>* The intervention is a combination between the procedure of Therapeutic plasma exchange and biological transfusion of convalescent plasma from donors that have have COVID-19<br>* Other names: Transfusion of convalescent plasma;|
| No Intervention: Control arm<br>In the control arm, patients will receive standard COVID-19 treatment | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | In percentage | 30 day period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partial pressure of arterial oxygen (PaO2) to fractional inspired oxygen (FiO2) ratio (P/F ratio) | Evolution of ratio | 7 day period | 
| C reactive protein (CRP) | Evolution of value | 7 day period | 
| Lactate dehydrogenase (LDH) | Evolution of value | 7 day period | 
| Ferritin | Evolution of value | 7 day period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Therapeutic Plasma Exchange, Convalescent Plasma