There is one clinical trial.
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.
Description: Mean days from admission as a suspected case of COVID with hospitalization criteria until dischargeMeasure: Mean hospitalization time Time: Through study completion, an average of 3 months
Description: Mean of delta of oxigenation index (PaO2/FiO2)Measure: Mean Oxigenation index evolution Time: Through study completion, an average of 3 months
Description: Rate of patients with evolution to severe ARDS (PaO2/FiO2 < 100)Measure: Rate of severe ARDS Time: Through study completion, an average of 3 months
Description: Rate of Dead caused by COVID-19 related complications and time to dead caused by COVID-19 complicationMeasure: Rate and time to dead Time: Through study completion, an average of 3 months
Description: Mean time with invasive mechanical ventilationMeasure: Mean time with invasive mechanical ventilation Time: Through study completion, an average of 3 months
Description: Time to negativization of RT-qPCR SARS-CoV-2 test.Measure: Time to Viral PCR Negativization Time: Through study completion, an average of 3 months.