COVID-19 infection has spread worldwide causing several deaths in few months Convalescent Plasma from COVID 19 donors has shown huge activity in small series from Chinese patients and currently many centers from USA and the European Union are assessing its use looking to avoid mortality and prolonged hospitalizations COVID-19-related
This is a collaborative, 4 arms , non randomized clinical trial assessing the use of Convalescent Plasma from COVID-19 recovered donors to be used in oncological and non-oncological patients with current severe COVID-19 infection or in patients with risk factors of major complications secondary to COVID-19 infection
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Patients that will participate in this clinical trial will be treated with Convalescent Plasma from COVID-19 donors regardless of the arm where they will be included
Fundacion Arturo Lopez Perez
Providencia, Santiago Metropolitan, Chile
RECRUITINGin-hospital mortality secondary to COVID-19 among patients treated with convalescent plasma
in-hospital mortality secondary to COVID-19 among patients treated with convalescent plasma
Time frame: 1 year
safety of the use of convalescent plasma drom COVID 19 donors
safety of convalescent plasma from COVID 19 donors (CTCAE V5.0)
Time frame: 1 year
Mortality at 30 days, 90 days, 6 months and 1 year
any cause of mortality during these periods
Time frame: 1 year
in-hospital Mortality COVID-19 related compared with non-treated population according to Chilean official reports
based on results from this trial comparing with official information
Time frame: through study completion, an average of 1 year
Number of days of hospitalization in high complexity facilities after convalescent plasma use
number of days of hospitalization in high complexity facilities after convalescent plasma use
Time frame: 1 year
Number of days of hospitalization in intensive care unit after convalescent plasma use
number of days of hospitalization in intensive care unit after convalescent plasma use
Time frame: 1 year
Number of days of mechanical ventilatory support in patients after convalescent plasma use
number of days of mechanical ventilatory support in patients after convalescent plasma use
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Total number of days of mechanical ventilatory support
total number of days of mechanical ventilatory support
Time frame: 1 year
Total number of hospitalization days in patients treated with convalescent plasma
total number of hospitalization days in patients treated with convalescent plasma
Time frame: 1 year
Number of hospitalization days in patients after treatment with convalescent plasma
total number of hospitalization days in patients after treatment with convalescent plasma
Time frame: 1 year
Viral load measuring
Viral load measuring
Time frame: 14 days
Immunological response in treated patients (COVID19-Immunoglobulin M and Immunoglobulin G, neutralizing antibodies)
COVID19-Immunoglobulin M and Immunoglobulin G, neutralizing antibodies
Time frame: day 1 of hospitalization
Negativization of COVID 19 load since convalescent plasma use
negativization of COVID 19 load since convalescent plasma use
Time frame: 14 days
Negativization of COVID 19 load since hospitalization
negativization of COVID 19 load since hospitalization
Time frame: 14 days
Negativization of COVID 19 load since first reported symptoms COVID-19 related
negativization of COVID 19 load since first reported symptoms COVID-19 related
Time frame: 14 days
Donor Interferon Gamma profile characterization
Interferon Gamma measurement from donor
Time frame: 1 day
Donor Granulocyte Macrophage Colony Stimulating Factor characterization
Granulocyte Macrophage Colony Stimulating Factor measurement from donor
Time frame: 1 day
Donor Tumor Necrosis Factor Alfa characterization
Tumor Necrosis Factor Alfa measurement from donor
Time frame: 1 day
Donor Interleukin -1 beta characterization
Interleukin -1 beta measurement from donor
Time frame: 1 day
Donor Interleukin-2 characterization
Interleukin -2 measurement from donor
Time frame: 1 day
Donor Interleukin-4 characterization
Interleukin -4 measurement from donor
Time frame: 1 day
Donor Interleukin-6 characterization
Interleukin -6 measurement from donor
Time frame: 1 day
Donor Interleukin-8 characterization
Interleukin -8 measurement from donor
Time frame: 1 day
Donor Interleukin-10 characterization
Interleukin -10 measurement from donor
Time frame: 1 day
Receptor Interferon Gamma profile characterization
Interferon Gamma measurement from receptor
Time frame: 1 day
Receptor Granulocyte Macrophage Colony Stimulating Factor characterization
Granulocyte Macrophage Colony Stimulating Factor measurement from receptor
Time frame: 1 day
receptor Tumor Necrosis Factor Alfa characterization
Tumor Necrosis Factor Alfa measurement from receptor
Time frame: 1 day
receptor Interleukin -1 beta characterization
Interleukin -1 beta measurement from receptor
Time frame: 1 day
Receptor Interleukin-2 characterization
Interleukin -2 measurement from receptor
Time frame: 1 day
Receptor Interleukin-4 characterization
Interleukin -4 measurement from receptor
Time frame: 1 day
Receptor Interleukin-6 characterization
Interleukin -6 measurement from receptor
Time frame: 1 day
Receptor Interleukin-8 characterization
Interleukin -8 measurement from receptor
Time frame: 1 day
Receptor Interleukin-10 characterization
Interleukin -10 measurement from receptor
Time frame: 1 day