Status:
COMPLETED
Convalescent Plasma for Patients With COVID-19: A Randomized, Single Blinded, Parallel, Controlled Clinical Study
Lead Sponsor:
Universidad del Rosario
Collaborating Sponsors:
Fundación Universitaria de Ciencias de la Salud
CES University
Conditions:
Coronavirus
Coronavirus Infection
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
PHASE3
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 a...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2020
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT04332835
Start Date
August 8 2020
End Date
November 15 2020
Last Update
November 27 2020
Active Locations (1)
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1
Universidad del Rosario
Bogota, Cundinamarca, Colombia, 11100