Clinical trial NCT04332380: Convalescent Plasma for Patients With COVID-19: A Pilot Study
Official title: Convalescent Plasma for Patients With COVID-19: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronavirus
Coronavirus Infection
Keywords: COVID-19
Coronavirus Disease 2019
Lead sponsor: Universidad del Rosario
Sponsor class: OTHER
Collaborators: name: CES University
name: Instituto Distrital de Ciencia Biotecnologia e Innovacion en salud
name: Fundación Universitaria de Ciencias de la Salud
First posted: 2020-04-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:Fulfilling all the following criteria

1. Aged between 18 and 60 years, male or female.
2. Hospitalized participants with diagnosis for COVID 19 by Real Time - Polymerase Chain Reaction.
3. Without treatment.
4. Moderate cases according to the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 6)".
5. Confusion, Urea, Respiratory rate, Blood pressure-65 (CURB-65) \>= 2.
6. Sequential Organ Failure Assessment score (SOFA) \< 6.
7. 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.
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. Patients who have suspicion or evidence of coinfections.
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.

Primary outcomes:
measure: Change in Viral Load
timeFrame: Days 0, 4, 7, 14 and 28
measure: Change in Immunoglobulin M COVID-19 antibodies Titers
timeFrame: Days 0, 4, 7, 14 and 28
measure: Change in Immunoglobulin G COVID-19 antibodies Titers
timeFrame: Days 0, 4, 7, 14 and 28
Secondary outcomes:
measure: Intensive Care Unit Admission
timeFrame: Days 7, 14 and 28
measure: Length of Intensive Care Unit stay
timeFrame: Days 7, 14 and 28
measure: Length of hospital stay (days)
timeFrame: Days 7, 14 and 28
measure: Requirement of mechanical ventilation
timeFrame: Days 7, 14 and 28
measure: Duration (days) of mechanical ventilation
timeFrame: Days 7, 14 and 28
measure: Clinical status assessed according to the World Health Organization guideline
timeFrame: Days 7, 14 and 28
measure: Mortality
timeFrame: Days 7, 14 and 28
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Universidad del Rosario
state: Cundinamarca
Study officials:
affiliation: Universidad del Rosario
name: Juan M Anaya Cabrera, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Infectious, D. & Outbreaks, D. Maintaining a safe and adequate blood supply during the pandemic outbreak of coronavirus disease ( COVID-19 ). OMS 1-5 (2020).