In December, 2019 on the planet the koronavirusny disease 2019 (COVID-19) caused by SARS-CoV-2 (a heavy acute respiratory syndrome) and which is characterized by the high speed of transfer and considerable mortality began to extend promptly. Symptoms of COVID-19 can vary from the lungs which are not demanding treatment to the progressing pneumonia, multiorgan insufficiency and even death. Today there is no effective treatment or vaccine.
The blood plasma of the donor convalescents (who had and recovered) was used in treatment of patients with other infections. This approach was applied at treatment the TORSO (SARS), a Middle Eastern respiratory syndrome (MERS), and fever Ebola, but it is not up to the end studied. Recently it was reported about improvement of results of a series of cases in China after plasma transfusion of donor convalescents of COVID-19. The management on supervision of quality of foodstuff and medicines of the USA (FDA) approved use in emergency situations of rekonvalestsentny plasma for patients with heavy or life-threatening COVID-19 recently.
In spite of the fact that use of rekonvalestsentny plasma in treatment of COVID-19 looks promising, proofs of efficiency are rather limited therefore this method of treatment remains experimental now. Besides, because of limited understanding of the mechanism and exact therapeutic components of rekonvalestsentny plasma there is no standardization or justification for the choice of the donor, quality control of rekonvalestsentny plasma or indications for its transfusion. It can explain the different therapeutic effects of rekonvalestsentny plasma observed for different diseases. For the solution of the matters the World Health Organization issued operating instructions of rekonvalestsentny plasma at a pandemic, supporting standardization of selection of donors and quality control of rekonvalestsentny plasma for the purpose of increase in a therapeutic effectiveness.
The group of authors from China conducted randomized clinical trial which purpose was assessment of efficiency and by-effects of therapy by the plasma of convalescents added to standard treatment, patients with heavy or life-threatening (COVID-19) with standard selection of donors and quality control of rekonvalestsentny plasma. Patients for a research were taken from 7 medical centers. These patients were in a random way distributed by means of computer accidental numbering (1:1) in two groups: for receiving standard treatment in combination with transfusion of rekonvalestsentny plasma or in the control group receiving one standard treatment. Randomization was carried out by a block method, and in process both groups were divided into subgroups stratified) on severity of COVID-19 (heavy or life-endangering). Both the doctor, and the patient knew about the accepted treatment. As donors of plasma patients with laboratory confirmed COVID-19 who completely recovered and were discharged from hospital more than 2 weeks ago were chosen. The intake of rekonvalestsentny plasma was carried out according to the standard procedure of an intake of plasma by means of a plasma exchange. The received plasma was frozen. The volume of transfusion of rekonvalestsentny plasma was from about 4 to 13 ml/kg of body weight of the recipient.
Following the results of this research, significant differences in time before clinical improvement at patients who received rekonvalestsentny plasma together with standard treatment in comparison with the patients receiving one standard treatment were not observed. Also in a secondary outcome the considerable difference in death rate within 28 days and in time from randomization to an extract was not observed. Therapy by rekonvalestsentny plasma is connected with higher quantity of negative takes of virus PTsR of smears from a nasopharynx at an interval of 24, 48 and 72 hours that demonstrates that therapy by rekonvalestsentny plasma at patients with COVID-19 is connected with anti-virus activity. Transfusion of rekonvalestsentny plasma can lead to by-effects, including febrile and allergic, hypotensive, hemolitic or septic reactions to transfusion, dispnoe, acute injury of lungs or a transfusion circulator overload. Thus, among patients with heavy or life-threatening COVID-19 the therapy by plasma of convalescents added to standard treatment slightly improved time before clinical improvement within 28 days in comparison with one standard treatment. Interpretation is limited to the early termination of test which, perhaps, there was insufficiently for identification of clinically important difference.