Coronavirus, Coronavirus Infection
Conditions
Keywords
COVID-19, Coronavirus Disease 2019
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
Interventions
DRUGPlasma
Day 1: CP-COVID19, 250 milliliters. Day 2: CP-COVID19, 250 milliliters.
DRUGStandard Therapy
Standard therapy defined by institutional protocol.
Sponsors
Fundación Universitaria de Ciencias de la Salud
CES University
Instituto Distrital de Ciencia Biotecnología e Innovacion en Salud
Universidad del Rosario
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Single Blinded
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Viral Load | Days 0, 4, 7, 14 and 28 | Copies of COVID-19 per ml |
| Change in Immunoglobulin G COVID-19 Titers | Days 0, 4, 7, 14 and 28 | Immunoglobulin G COVID-19 antibodies |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay (days) | Days 7, 14 and 28 | Days of Hospitalization (days 7, 14 and 28) |
| Requirement of mechanical ventilation | Days 7, 14 and 28 | Proportion of patients with mechanical ventilation (days 7, 14 and 28) |
| Intensive Care Unit Admission | Days 7, 14 and 28 | Proportion of patients with Intensive Care Unit Admission requirement (days 7, 14 and 28) |
| Clinical status assessed according to the World Health Organization guideline | Days 7, 14 and 28 | 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) |
| Mortality | Days 7, 14 and 28 | Proportion of death patients at days 7, 14 and 28 |
| Duration (days) of mechanical ventilation | Days 7, 14 and 28 | Days with mechanical ventilation (days 7, 14 and 28) |
| Length of Intensive Care Unit stay | Days 7, 14 and 28 | Days of Intensive Care Unit management (days 7, 14 and 28) |
Countries
Colombia
Outcome results
None listed