Dados do Trabalho

Título

High-dose convalescent plasma for severe covid-19

Introdução

COVID-19 is a potentially fatal disease without specific therapy. Evidence suggests that convalescent plasma (CCP) may be useful against severe cases of SARS-CoV-2. Most people, when they come into contact with SARS-CoV-2, manage to produce immune defenses and evolve with mild conditions, with immunological mechanisms being crucial in fighting infections. Evidence suggests that convalescent plasma (PCC) may be useful against severe cases of SARS-CoV-2.

Objetivo (s)

To compare the survival curve, up to the 60th day after randomization, of patients with severe COVID-19 hospitalized and treated with convalescent plasma with the control group; compare the time (in days) of mechanical ventilation and hospital stay between the groups; compare the results with age (above and below the median); compare inflammatory parameters and evaluate the complication rate of plasma transfusion in the intervention group.

Material e Métodos

Multicenter, randomized, controlled clinical trial in five hospitals in Brazil between April and December 2020, to assess whether high-dose PCC transfusion can benefit critically ill patients with COVID-19. Critically ill patients hospitalized within 10 days of symptom onset were eligible. The study was designed for a sample of 120 participants. Three daily doses (600 mL each) of CCP transfusion (neutralizing antibody titer ≥ 64) were added to the standard treatment, for the Intervention group, the Control group did not receive any additional treatment.

Resultados e Conclusão

One hundred and ten participants were enrolled and three were subsequently excluded. Of the 107 participants evaluated, 36 were randomized to receive CP and 71 to the control group. The mean age between the groups was 56 ± 15 years (CCP) and 59 ± 12 years (control). Mortality rates were 22% in the PCC and 25% in the control group (OR 0.84; 95% CI, 0.32-2.25; P = 0.81) at day 30, at the 60-day assessment were 31% (CCP) and 35% (control) (OR 0.81; 95% CI, 0.35-1.86; P = 0.67). The number of days without mechanical ventilation at the 30-day assessment was 12.5 (CCP; range, 0-30) and 12 (control; 0-30; P = 0.82). (CCP; 0-60) and 39 (control; 0-60; P = 0.80). Length of stay was not different between groups (P = 0.43). CCP transfusion had no significant impact on serum inflammatory markers. Addition of high-dose PCC has failed to benefit patients with severe COVID-19.

Palavras-chave

Neutralizing antibodies. COVID 19. Coronavirus infections.Passive Immunization. SARS-CoV-2.

Agradecimentos

Fundação de Amparo à Pesquisa do Estado de São Paulo (Processo nº 20/05367-3)