The data analysis of the randomized and controlled clinical trial called TSUNAMI, promoted by ISS and AIFA and coordinated by ISS, on the therapeutic role of convalescent plasma in patients who developed COVID-19 disease was concluded.
The study compared the effect of convalescent plasma with high titer of neutralizing antibodies (³1: 160), associated with standard therapy, compared to standard therapy alone in patients with COVID-19 and pneumonia with mild to moderate ventilatory impairment (defined by a PaO2 / FiO2 ratio between 350 and 200). 27 clinical centers distributed throughout the country took part in the study and enrolled 487 patients (of which 324 in Tuscany, 77 in Umbria, 66 in Lombardy and 20 from other regions). Demographics, existing comorbidities, and concomitant therapies were similar in the two patient groups, 241 assigned to plasma and standard therapy (231 evaluable), and 246 to standard therapy alone (239 evaluable). There was no statistically significant difference in the primary end point ("need for invasive mechanical ventilation, defined by a ratio of PaO2 / FiO2 <150, or death within thirty days from the date of randomization") between the group treated with plasma and that treated with standard therapy.
Overall, TSUNAMI did not therefore show a plasma benefit in terms of reducing the risk of respiratory worsening or death in the first thirty days.
The analysis of the different subgroups confirmed the absence of significant differences between the two treatments. Only in the case of patients with less severe respiratory impairment (with a PaO2 / FiO2 ratio ≥ 300 at enrollment), a signal in favor of plasma emerged but did not reach statistical significance (p = 0.059). This may suggest the opportunity to further investigate the potential therapeutic role of plasma in subjects with mild-to-moderate COVID and in the very early stages of the disease. Treatment was overall well tolerated, although adverse events were more frequent in the plasma group. The results of the TSUNAMI study are in line with those of the international literature, mainly negative, except for series of patients treated very early with high titre plasma. The TSUNAMI study, which involved a network of transfusion centers, virology laboratories and clinical centers at national level, represents a virtuous model of a research platform that confirms the ability of our country to produce high-level scientific evidence, even in emergency situations. like those that characterize a pandemic period. These evidences are indispensable for improving the quality of clinical care for patients.