Convalescent plasma (CP) therapy in COVID-19 disease may improve clinical outcome in severe disease. This pilot study was undertaken to inform feasibility and safety of further definitive studies. This was a prospective, interventional and randomized open label pilot trial in patients with severe COVID-19. Twenty COVID-19 patients received two 200 ml transfusions of convalescent patient CP over 24-h compared with 20 who received standard of care. The primary outcome was the requirement for ventilation (non-invasive or mechanical ventilation). The secondary outcomes were biochemical parameters and mortality at 28 days. The CP group were a higher risk group with higher ferritin levels ( p < 0.05) though respiratory indices did not differ. The primary outcome measure was required in 6 controls and 4 patients on CP (risk ratio 0.67, 95% CI 0.22–2.0, p = 0.72); mean time on ventilation (NIV or MV) did not differ. There were no differences in secondary measures at the end of the study. Two patients died in the control and one patient in the CP arm. There were no significant differences in the primary or secondary outcome measures between CP and standard therapy, although a larger definitive study is needed for confirmation. However, the study did show that CP therapy appears to be safe in hospitalized COVID-19 patients with hypoxia. Clinical trials registration NCT04356534: 22/04/2020.
【저자키워드】 Virology, Randomized controlled trials, 【초록키워드】 therapy, Mortality, Trial, severe COVID-19, mechanical ventilation, hypoxia, feasibility, Ventilation, risk, ferritin, COVID-19 disease, Clinical outcome, Randomized, clinical, Patient, Control, plasma, convalescent patient, hospitalized COVID-19 patient, Standard therapy, risk ratio, severe disease, COVID-19 patient, Safe, open, Standard of care, Non-invasive, Biochemical parameters, Primary outcome, respiratory indices, hospitalized COVID-19 patients, no significant differences, higher risk, 95% CI, no significant difference, confirmation, open label, Secondary outcomes, pilot study, no difference, one patient, two patients, no differences, measure, CP group, primary outcome measure, secondary outcome, NIV, IMPROVE, not differ, died, required, appear, Two patient, biochemical parameter, ferritin level, respiratory indice, secondary outcome measure, 【제목키워드】 Convalescent plasma therapy, Patient, Controlled trial, severe COVID-19 disease,