Home » Covid-19, Aifa and Iss: the plasma of the healed does not work

Covid-19, Aifa and Iss: the plasma of the healed does not work

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On Facebook and not only for some time, groups have been born that launch appeals for the urgent collection of hyperimmune plasma to save those affected by Covid. As we had also told through this testimony, the plasma of people already healed contains antibodies that could neutralize the Coronavirus or reduce its viral load. To ascertain whether this is really the case, the Istituto Superiore di Sanità and Aifa jointly conducted the Tsunami clinical study to evaluate the therapeutic role of convalescent plasma in patients who have developed Covid-19 disease. Today the verdict has come: the plasma ‘cure’ does not reduce the risk of respiratory deterioration or death in the first thirty days. The study involved a network of transfusion centers, virology laboratories and clinical centers at a national level and for this reason it represents a virtuous model of research platform.

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The clinical study (randomized and controlled) compared the effect of convalescent plasma with a high titre of neutralizing antibodies (greater than or equal to 1: 160), associated with standard therapy, compared to standard therapy alone in patients with Covid-19 and pneumonia. with mild to moderate ventilatory impairment. 27 clinical centers distributed throughout the country participated in the study and enrolled 487 patients (of which 324 in Tuscany, 77 in Umbria, 66 in Lombardy and 20 from other regions). Of these, 241 were assigned to treatment with plasma and standard therapy (231 evaluable), and 246 to standard therapy alone (239 evaluable). Analyzing the data – reads a joint note – the Tsunami study did not reveal a benefit of plasma in terms of reducing the risk of respiratory worsening or death in the first thirty days of therapy.

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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 compromise did a signal in favor of plasma emerge, which however did not reach statistical significance. Precisely for this reason, experts hypothesize that the potential therapeutic role of plasma in subjects with mild-moderate Covid-19 and in the very early stages of the disease can be further studied. 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 cases of patients treated very early with high titre plasma.

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On Facebook there is the group ‘We support hyperimmune plasma treatment’ with over 27,000 members and then ‘We support hyperimmune plasma’ which has over 2,000 members and then there are the messages on Whatsapp they create long chains. The message is always the same: the usefulness of the gesture is explained, that the potential donors of plasma can be healed women or men, with an age between 18 and 65 years and a weight of no less than 50 kg and that you have to be afraid of nothing. To foment these groups, the sometimes conflicting results of research. Just yesterday, for example, the results of a phase 2 study conducted at Hackensack University Medical Center, in New Jersey, which evaluated the conditions of 51 patients with Covid-19 treated with plasma with high antibody titer were released. .

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The international study

The results of the trial, published in detail in the journal JCI Insights, appear to confirm the safety of the treatment and the transfer of antiviral antibodies without preventing recipients from producing their own antibodies. Patients, all with signs of Covid-19 pneumonia, were divided into two groups according to the need for respiratory assistance and received an infusion of plasma with a high antibody titer: patients not mechanically ventilated showed a survival rate significantly higher (88.9%) at 30 days, with an overall survival of 72.5% compared to a comparison group. Patients who required mechanical ventilation instead showed a mortality rate of 46.7% at 30 days, with an overall mortality rate of 71% compared to the comparator group.

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