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

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

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

Completed
Coronavirus
Coronavirus Infection

Drug: Plasma

Day 1: CP-COVID19, 250 milliliters. Day 2: CP-COVID19, 250 milliliters.
Other Name: Convalescent Plasma COVID-19

Drug: Standard Therapy

Standard therapy defined by institutional protocol.

Eligibility Criteria

Inclusion Criteria:Fulfilling all the following criteria

1. Olerder than 18.

2. Hospitalized participants with diagnosis of COVID 19 by Real Time - Polymerase Chain
Reaction.

3. Severe cases according to the official guideline "Pneumonia Diagnosis and Treatment
Scheme for Novel Coronavirus Infection (Trial Version 7)".

4. Sequential Organ Failure Assessment score (SOFA) < 6.

5. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Female subjects who are pregnant or breastfeeding.

2. Patients with prior allergic reactions to transfusions.

3. Critical ill patients in intensive care units with requierment of Invasive Mechanical
Venitlation.

4. Patients with surgical procedures in the last 30 days.

5. Patients with active treatment for cancer (Radiotherapy or Chemotherapy).

6. 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).

7. Demonstrated coinfection that explains the patient's symptoms

8. End-stage chronic kidney disease (Glomerular Filtration Rate <15 ml / min / 1.73 m2).

9. Child Pugh C stage liver cirrhosis.

10. High cardiac output diseases.

11. Autoimmune diseases or Immunoglobulin A nephropathy.

12. Patients have any condition that in the judgement of the Investigators would make the
subject inappropriate for entry into this study.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 100 Years
Countries
Colombia
Locations

Universidad del Rosario
Bogota, Cundinamarca, Colombia

Juan M Anaya Cabrera, MD, PhD, Study Director
Universidad del Rosario

Universidad del Rosario
NCT Number
Keywords
Covid-19
Coronavirus disease 2019
MeSH Terms
COVID-19
Coronavirus Infections