Covid, hyperimmune plasma doesn’t work. Iss-Aifa report
Hyperimmune plasma does not reduce the risk of worsening or death: the results of the Tsunami clinical study, promoted by the Higher Institute of Health and the Italian Medicines Agency
Convalescent plasma therapy does not reduce the risk of worsening in Covid-19. This is the result of the randomized and controlled clinical trial 'Tsunami' , promoted by the Higher Institute of Health and the Italian Medicines Agency (Aifa). All the details.
I STUDY
The trial, which involved 27 clinical centers distributed throughout the country, involving 487 patients (of which 324 in Tuscany, 77 in Umbria, 66 in Lombardy and 20 from other regions), compared "the effect of convalescent plasma to 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) " , explains Aifa .
The two patient groups (241 patients received plasma treatment and 246 were treated with standard therapy) had the same demographic characteristics and similar existing comorbidities and concomitant therapies.
THE RESULTS
In the comparison, "no statistically significant difference was observed 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 treated with plasma and that treated with standard therapy ".
NO BENEFITS FOR RISK REDUCTIONS
What does it mean? That the use of plasma does not allow a reduction in 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”, explains Aifa.
PLASMA: SMALL BENEFITS IN LESS SERIOUS CASES
Plasma seems to have benefits, however, in less severe cases. "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 this signal "however, did not reach statistical significance (p = 0.059) ".
It may be useful to investigate the effects of plasma for mild-moderate cases of Covid-19 and in the very early stages of the disease.
RESULTS IN LINE WITH OTHER STUDIES
The results are not surprising. What emerged is "in line" with the results "of the international literature, mainly negative, except for cases of patients treated very early with high titre plasma".
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/covid-il-plasma-iperimmune-non-funziona-report-iss-aifa/ on Sat, 10 Apr 2021 16:55:29 +0000.