Convalescent Plasma for Patients With COVID-19: A Randomized, Single Blinded, Parallel, Controlled Clinical Study

Study Overview
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Brief Summary
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Convalescent plasma (CP) has been used in recent years as an empirical treatment strategy when there is no vaccine or treatment available for infectious diseases. In the latest viral epidemics, such as the Ebola outbreak in West Africa in 2014, the World Health Organization issued a document outlining a protocol for the use of whole blood or plasma collected from patients who have recovered from the Ebola virus disease by transfusion to empirically treat local infectious outbreaks

Detailed Description
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The process is based on obtaining plasma from patients recovered from COVID-19 in Colombia, and through a donation of plasma from the recovered, the subsequent transfusion of this to patients infected with coronavirus disease (COVID-19). Our group has reviewed the scientific evidence regarding the application of convalescent plasma for emergency viral outbreaks and has recommended the following protocol

Official Title
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Convalescent Plasma for Patients With COVID-19: A Randomized, Single Blinded, Parallel, Controlled Clinical Study

Conditions
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Coronavirus, Coronavirus Infection

Intervention / Treatment
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* Drug: Plasma
* Drug: Standard Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:Fulfilling all the following criteria Olerder than 18. Hospitalized participants with diagnosis of COVID 19 by Real Time - Polymerase Chain Reaction. Severe cases according to the official guideline Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 7). Sequential Organ Failure Assessment score (SOFA) < 6. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Female subjects who are pregnant or breastfeeding. Patients with prior allergic reactions to transfusions. Critical ill patients in intensive care units with requierment of Invasive Mechanical Venitlation. Patients with surgical procedures in the last 30 days. Patients with active treatment for cancer (Radiotherapy or Chemotherapy). HIV diagnosed patients with viral failure (detectable viral load> 1000 copies / ml persistent, two consecutive viral load measurements within a 3 month interval, with medication adherence between measurements after at least 6 months of starting a new regimen antiretrovirals). Demonstrated coinfection that explains the patient's symptoms End-stage chronic kidney disease (Glomerular Filtration Rate <15 ml / min / 1.73 m2). Child Pugh C stage liver cirrhosis. High cardiac output diseases. Autoimmune diseases or Immunoglobulin A nephropathy. Patients have any condition that in the judgement of the Investigators would make the subject inappropriate for entry into this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Participants included in the experimental group will receive 500 milliliters of convalescent plasma, distributed in two 250 milliliters transfusions on the first and second day after starting the protocol. Simultaneously, they will receive the standard therapy defined by institutional protocol. | Drug: Plasma<br>* Day 1: CP-COVID19, 250 milliliters. Day 2: CP-COVID19, 250 milliliters.<br>* Other names: Convalescent Plasma COVID-19;Drug: Standard Therapy<br>* Standard therapy defined by institutional protocol.<br>|
| Active Comparator: Control Group<br>Participants included in the control group will receive standard therapy defined by institutional protocol. | Drug: Standard Therapy<br>* Standard therapy defined by institutional protocol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Viral Load | Copies of COVID-19 per ml | Days 0, 4, 7, 14 and 28 | 
| Change in Immunoglobulin G COVID-19 Titers | Immunoglobulin G COVID-19 antibodies | Days 0, 4, 7, 14 and 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensive Care Unit Admission | Proportion of patients with Intensive Care Unit Admission requirement (days 7, 14 and 28) | Days 7, 14 and 28 | 
| Length of Intensive Care Unit stay | Days of Intensive Care Unit management (days 7, 14 and 28) | Days 7, 14 and 28 | 
| Length of hospital stay (days) | Days of Hospitalization (days 7, 14 and 28) | Days 7, 14 and 28 | 
| Requirement of mechanical ventilation | Proportion of patients with mechanical ventilation (days 7, 14 and 28) | Days 7, 14 and 28 | 
| Duration (days) of mechanical ventilation | Days with mechanical ventilation (days 7, 14 and 28) | Days 7, 14 and 28 | 
| Clinical status assessed according to the World Health Organization guideline | 1. Hospital discharge; 2. Hospitalization, not requiring supplemental oxygen; 3. Hospitalization, requiring supplemental oxygen (but not Noninvasive Ventilation/ HFNC); 4. Intensive care unit/hospitalization, requiring Noninvasive Ventilation/ HFNC therapy; 5. Intensive care unit, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation; 6. Death. (days 7, 14 and 28) | Days 7, 14 and 28 | 
| Mortality | Proportion of death patients at days 7, 14 and 28 | Days 7, 14 and 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Coronavirus Disease 2019