Novi protokol za izbor davaoca plazme nakon SARS-CoV-2 infekcije
Sažetak
Uvod/Cilj. Infekcija Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) u 2019. godini predstavlja globalni problem. U ovom trenutku (oktobar 2020. godine), ne postoji vakcina, niti efikasan tretman zaraženih bolesnika. Primena krvne plazme bogate antitelima specifičnim za SARS-CoV-2 može da bude sigurna i efikasna terapija za bolesnike sa COVID-19. Metode. Ispitivanjem je obuhvaćeno ukupno 768 bolesnika čiji su uzorci krvne plazme bili prikupljeni u vremenskom intervalu od 1. maja 2020. do 15. avgusta 2020. godine. Bolesnici, uključeni u studiju, su bili iz COVID-19 bolnica i ambulanti. In-house ELISA testovi su razvijeni za merenje koncentracije antitela na S1S2 spike i antitela na nukleoprotein (anti-np) (IgG, IgA, IgM) SARS-CoV-2. Krvna plazma rekonvalescenata je selektivno sakupljana prema koncentraciji specifičnih antitela. Rezultati. Najviše koncentracije anti S1S2 spike ili anti-np IgG specifičnih antitela detektovane su kod bolesnika sa srednje teškom/teškom kliničkom formom infekcije. Ekstremno visoke koncetracije anti S1S2 spike IgG i anti-np IgG nađene su kod 3%, odnosno 6% bolesnika oporavljenih od teškog oblika COVID-19. Od ispitanih hospitalizovanih bolesnika, 63% i 51% su imali minimalne vrednosti anti S1S2 spike i anti np antitela, redom. Nakon 60 dana, u plazmi izabranih donora koncentracija anti S1S2 spike IgG i anti-np antitela porasla je kod 67%, odnosno 58% donora, redom. Zaključak. In-house razvijeni ELISA testovi omogućavaju novi protokol za odabir davaoca krvne plazme oporavljenih od SARS-CoV-2 infekcije.
Reference
Wiersinga WJ, Rhodes A, Cheng AC, Peacock SJ, Prescott HC. Pathophysiology, Transmission, Diagnosis, and Treatment of Coronavirus Disease 2019 (COVID-19): A Review. JAMA 2020; 324(8): 782‒93.
Park A. Blood Plasma Treatment for Coronavirus Set to Get Its First Trial Run in New York. Available from: https://time.com/5809955/blood-plasma-coronavirus/[cited 2020 March 26]
Shen C, Wang Z, Zhao F, Yang Y, Li J, Yuan J, et al. Treatment of 5 Critically Ill Patients With COVID-19 With Convales-cent Plasma. JAMA 2020; 323(16): 1582‒9.
Li L, Zhang W, Hu Y, Tong X, Zheng S, Yang J, et al. Effect of Convalescent Plasma Therapy on Time to Clinical Improve-ment in Patients With Severe and Life-threatening COVID-19: A Randomized Clinical Trial. JAMA 2020; 324(5): 460‒70.
Wang C, Li W, Drabek D, Okba NMA, van Haperen R, Oster-haus ADME, et al. A human monoclonal antibody blocking SARS-CoV-2 infection. Nat Commun 2020; 11(1): 2251.
Brouwer PJM, Caniels TG, van der Straten K, Snitselaar JL, Aldon Y, Bangaru S, et al. Potent neutralizing antibodies from COVID-19 patients define multiple targets of vulnerability. Science 2020; 369(6504): 643‒50.
Food and Drug Administration. Coronavirus disease 2019 (COVID-19) EUA nformation. 2020. Available at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/ emer-gency-use-authorization#covid19euas. [accessed 2020 August 31].
Grady D. Blood Plasma From Survivors Will Be Given to Coronavirus Patients. Available from: www.nytimes.com › health › plasma [updated 2020 August 4].
The COVID-19 Treatment Guidelines Panel’s Statement on the Emergency Use Authorization of Convalescent Plasma for the Treatment of COVID-19. Available from: https://www.covid19treatmentguidelines.nih.gov/ [updated 2020 September 1]
Lauer SA, Grantz KH, Bi Q, Jones FK, Zheng Q, Meredith HR, et al. The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Es-timation and Application. Ann Intern Med 2020; 172(9): 577‒82.
Guo L, Ren L, Yang S, Xiao M, Chang D, Yang F, et al. Profil-ing Early Humoral Response to Diagnose Novel Coronavirus Disease (COVID-19). Clin Infect Dis 2020; 71(15): 778‒85.
Zhao J, Yuan Q, Wang H, Liu W, Liao X, Su Y, et al. Antibody Responses to SARS-CoV-2 in Patients With Novel Corona-virus Disease 2019. Clin Infect Dis 2020; 71(16): 2027‒34.
National Institutes of Health website. Coronavirus disease 2019 (COVID-19) treatment guidelines. Available from: https://www.covid19treatmentguidelines.nih.gov/ [accessed 2020 July 1].
Joyner MJ, Wright RS, Fairweather D, Senefeld JW, Bruno KA, Klassen SA, et al. Early safety indicators of COVID-19 conva-lescent plasma in 5000 patients. J Clin Invest 2020; 130(9): 4791‒7.
U.S. Food and Drug Administration. Convalescent plasma let-ter of authorization. Available from: https://www.fda.gov
/media/141477/download. [accessed 2020 August 31].
U.S. Food and Drug Administration. EUA 26382: Emergency Use Authorization (EUA) Request. Available from: www.fda.gov/media/141481/download [accessed 2020 Sep-tember 6].
Edwards T , Semple MG , De Weggheleire A , Claeys Y , De Crop M, Menten J et al. Design and analysis considerations in the Ebola_Tx trial evaluating convalescent plasma in the treat-ment of Ebola virus disease in Guinea during the 2014–2015 outbreak. ClinTrials 2016; 13(1):13–21.
Choi JY. Convalescent Plasma Therapy for Coronavirus Dis-ease 2019. Infect Chemother 2020; 52(3): 307‒16.
Convalescent Plasma Collection Program. Available from: health.mil › Coronavirus › COVID. [accessed 2020 September 29]
Yiğenoğlu TN, Hacıbekiroğlu T, Berber I, Dal MS, Baştürk A, Namdaroğlu S. Convalescent plasma therapy in patients with COVID‐19. J Clin Apher 2020; 35(4): 367‒73.
Li Z, Yi Y, Luo X, Xiong N, Liu Y, Li S, et al. Development and clinical application of a rapid IgM-IgG combined antibody test for SARS-CoV-2 infection diagnosis. J Med Virol 2020; 92(9): 1518‒24.
Duan K, Liu B, Li C, Zhang H, Yu T, Qu Y, et al. The Feasibil-ity of Convalescent Plasma Therapy in Severe COVID‐19 Pa-tients:a Pilot Study. medRxiv 2020; doi: 10.1101/2020.03.16.20036145.
Casadevall A, Scharff MD. Return to the past: the case for an-tibody-based therapies in infectious diseases. Clin Infect Dis 1995; 21(1): 150‒61.
Casadevall A. Passive antibody administration (immediate im-munity) as a specific defense against biological weapons. Emerg Infect Dis 2002; 8(8): 833‒41.
Wiersinga WJ, Rhodes A, Cheng AC, Peacock SJ, Prescott HC. Pathophysiology, Transmission, Diagnosis, and Treatment of Coronavirus Disease 2019 (COVID-19): A Review. JAMA 2020; 324(8):782−93.
