Convalescent Plasma vs Human Immunoglobulin to Treat COVID-19 Pneumonia
Status:
Completed
Trial end date:
2020-11-26
Target enrollment:
Participant gender:
Summary
Background: On December 2019, a new human coronavirus infection (COVID-19) was detected in
China. Its infectivity and virulence characteristics caused a rapid spread, being declared
pandemic on March 2020. The mortality attributed to the infection ranges between 3 and 10%.
Main risk factors are age, male sex, and chronic degenerative comorbidities. Due to the
absence of therapeutic options, potential alternatives such as human immunoglobulin or plasma
from convalescent patients have been administered. Due to the severity of the disease and the
associated mortality, it is urgent to find therapeutic alternatives.
Objective: To assess the safety and efficacy of the administration of Convalescent plasma vs
human immunoglobulin in critically ill patients with COVID-19 infection.
Material and methods: Randomized Controlled trial of patients diagnosed with respiratory
infection by COVID-19, with severe respiratory failure without indication of mechanical
ventilation, or those who due to their severity are intubated upon admission. Randomization
will be performed 2:1 to receive plasma from convalescent patients or human immunoglobulin.
Outcomes: The primary outcome will be time to discharge from hospital for improvement. The
safety outcomes will be: Kirby index (PaO2/FiO2) evolution and dead.