Rome, April 8 (beraking latest news Health) – Convalescent plasma therapy has shown no benefit to Covid patients in terms of reducing the risk of respiratory worsening or death. It is the result of the randomized and controlled clinical study ‘Tsunami’, promoted by the Higher Institute of Health and the Italian Medicines Agency Aifa, and coordinated by the ISS.
The study – recalls a joint note – compared the effect of convalescent plasma with a high titer of neutralizing antibodies, associated with standard therapy, compared to standard therapy alone in patients with Covid-19 and pneumonia with mild to moderate ventilatory impairment (defined from a PaO2 / FiO2 ratio between 350 and 200). 27 clinical centers distributed throughout the country participated in the study, which 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).
“No statistically significant difference was observed in the primary end-point (need for invasive mechanical ventilation, defined by a ratio of PaO2 / FiO2 less than 150, or death within 30 days from the date of randomization),” the group treated with plasma and that treated with standard therapy. Overall Tsunami did not therefore show a benefit of plasma in terms of reducing the risk of respiratory worsening or death in the first 30 days “.
The analysis of the different subgroups confirmed the absence of significant differences between the two treatments, continue Aifa and Iss. Only in the case of patients with less severe respiratory impairment (PaO2 / FiO2 ratio greater than or equal to 300 at enrollment) did a signal in favor of plasma emerge, which however did not reach statistical significance. “This – indicate the authors – could suggest the opportunity to further study the potential therapeutic role of plasma in subjects with mild-moderate Covid and in the very early stages of the disease”.
The treatment was overall well tolerated, although adverse events were more frequent in the group that received the plasma, the note continues. The results of the Tsunami study are considered “in line with those of the international literature, mainly negative, except for cases of patients treated very early with high titre plasma”.
According to the promoters, the Tsunami study, which involved a network of transfusion centers, virology laboratories and clinical centers on a 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 such as those that characterize a pandemic period. These evidences are indispensable for improving the quality of clinical care for the sick “.