Convalescent Plasma for the Treatment of COVID-19: Protocol for access and use in Venezuela
Keywords:
COVID-19; convalescent plasma; rapid diagnostic testsAbstract
On December 2019, in Wuhan, China, there was an unusual increase in cases of a fast-progressing acute respiratory infection with high fatality rate. Soon after, the causing agent is identified, a coronavirus called SARS-CoV-2, and a new disease, COVID-19 is characterized. Currently, in the absence of specific, effective and safe treatments, it is justified to explore all scientifically based alternatives available to us, such as the use of Convalescent Plasma (PC-CoV19) as acoadjutant treatment of COVID-19.Plasma from patients who have recovered from an infectious disease, Convalescent Plasma, has been used in the treatment of other infectious disease. There is recent history of its use in diseases caused by another type of coronavirus, and clinical experiences and studies have already been published with preliminary results during this pandemic. Quimbiotec, a Venezuelan State public company that produces blood products and recombinant drugs, and Banco Municipal de Sangre, defined a protocol to promote conditions for aphaeresis, processing, conservation, storage, distribution, transfusion, and evaluation of safety and efficacy of PC-CoV19 as an alternative for the treatment of COVID-19 in Venezuela. This protocol includes identification of capacities, physical structure, equipment and skills, talent, professionals needed, as well as a definition of processes to establish controlled and auditable routines to lay the foundations for access and use of PC-CoV19 in the Venezuela Health System, and prepare the design and implementation of clinical studies. The protocol and currently critical points in its implementation, as well as tools and strategies used for its solution, are presented.
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References
AnkcornM., Gallacher J., Ijaz S., Taha Y., Harvala H., Maclennan S., Thomson, E.C.,
Davis, C., Singer, J.B., Da Silva, F.A., Smollett, K., Niebel, M., Semple, M.G.,
Tedder, R.C., & McPherson, S. (2019).Convalescent plasma the rapy for persistent
hepatitis E virus infection. Journal of Hepatology, 71(2), 434-438.
Recuperado en: https://doi.org/10.1016/j.jhep.2019.04.008
Arabi, Y.M., Balkhy, H., Hajeer, A.H., Bouchama, A., Hayden, F. G., Al-Omari, A.,
Al-Hameed, F. M., Taha, Y., Shindo, N., Whitehead, J., Merson, L., AlJohani, S., Al
Khairy, K., Carson, G., Luke, T. C., Hensley, L., Al-Dawood, A., Al-Qahtani, S.,
Modjarrad, K., …Fowler, R. (2015). Feasibility, safety, clinical, and laboratory effects of
convalescent plasma therapy for patients with Middle East respiratory syndrome
coronavirus infection: a study protocol. Springer Plus, 4, 709.
Recuperado en: https://doi.org/10.1186/s40064-015-1490-9
Arabi, Y.M., Hajeer, A.H., Luke, T., Raviprakash, K., Balkhy, H., Johani, S., Al
Dawood, A., Al-Qahtani, S., Al-Omari, A., Al-Hameed, F., Hayden, F. G., Fowler, R.,
Bouchama, A., Shindo, N., Al-Khairy, K., Carson, G., Taha, Y., Sadat, M., & Alahmadi,
M. (2016). Feasibility of Using Convalescent Plasma Immunotherapy for MERS-CoV
Infection, Saudi Arabia. Emerging Infectious Diseases, 22(9), 1554-1561.
Recuperado en:https://dx.doi.org/10.3201/eid2209.151164
Bikdeli, B., Madhavan, MV., Jiménez, D., Chuich,T., Dreyfus, I.,Driggin, E., Der
Nigoghossian, C., Ageno, W., Madjid, M., Guo,Y., Tang, L.V., Hu, Y., Giri, J.,
Cushman, M., Quéré, I., Dimakakos, E.P., Gibson,C.M., Lippi, G., Favaloro, E.J., …
Lip, G.Y.(2020).COVID-19 and Thrombotic or Thromboembolic Disease: Implications
for Prevention, Antithrombotic Therapy, and Follow-up. Journal of the American
College of Cardiology, 75(23), 2950-2973.
Recuperado en: https://doi.org/10.1016/j.jacc.2020.04.031
Bloch, E., Shoham, S., Casadevall, A., Sachais, B., Shaz, B., Winters, J., van Buskirk, C.,
Grossman, B.J., Joyner, M., Henderson J.P.,Pekosz, A., Lau, B., Wesolowski, A., Katz,
L., Shan, H., Auwaerter,P.G., Thomas, D., Sullivan, D.J., Paneth, N., Tobian, A.A.
(2020). Deployment of convalescent plasma for the prevention and treatment of
COVID-19. The Journal of Clinical Investigation.
Recuperado en: https://doi.org/10.1172/JCI138745
Casadevall, A., & Scharff, M.D. (1995). Return to the past: The case of antibody-based
therapies in infectious diseases. Clinical Infectious Diseases, 21(1)150-161.
Recuperado en: https://doi.org/10.1093/clinids/21.1.150
Casadevall, A., & Pirofski, L. (2020). The convalescent sera option for containing
COVID-19. The Journal of Clinical Investigation,130(4),1545-1548.
Recuperado en: https://doi.org/10.1172/JCI138003
Casadevall, A., Dadachova, E., &Pirofski, L. (2004). Passive antibody therapy for
infectious diseases. Nature Reviews Microbiology, 2, 695–703.
Recuperado en: https://doi.org/10.1038/nrmicro974
Chen L., Xiong J., Bao L., & Shi, Y. (2020). Convalescent plasma as a potential therapy
for COVID-19. Lancet Infectious Diseases, 20(4), 398-400.
Recuperado en: https://doi.org/10.1016/S1473-3099(20)30141-9
Cheng, Y., Wong ,R., Soo, Y.O, Wong, W.S., Lee, C.K., Ng, M.H., Chan, P., Wong,
K.C., Leung, C.B., &Cheng, G. (2005). Use of convalescent plasma therapy in SARS
patients in Hong Kong. European Journal of Clinical Microbiology and Infectious
Diseases, 24(1), 44–46.
Recuperado en:https://doi.org/10.1007/s10096-004-1271-9
Comité Científico para la Seguridad Transfusional (CCST), España. (2020).
Recomendaciones para obtención de plasma de donantes convalecientes de COVID-19.
Ministerio de Sanidad. Recuperado el 6 marzo de 2020. Recuperado en:
https://www.mscbs.gob.es/profesionales/saludPublica/ccayes/alertasActual/nCovChina/
ocumentos/COVID-19_RecPlasma_donantes.pdf 7 de abril 2020
Comité Terapéutico COVID-19. MPPS. (2020). Guía para el manejo y tratamiento de
contactos y pacientes con COVID-19. Ministerio del Poder Popular para la Salud.
República Bolivariana de Venezuela. Versión 24 de Abril. Recuperado el 24 de abril de
Recuperado en: http://www.mpps.gob.ve/index.php/sistemas/descargas
Delgado, G; Vargas, J., Mercado, M., Gaviria, P., & Alvarez, C. (2020). Toward to
establish selection criteria for rapid serological tests for COVID-19. Infectio, 24(3).
Recuperado en: http://dx.doi.org/10.22354/in.v24i3.869
Duan, K., Liu, B., Li,C., Zhang,H., Yu, T., Qu,J., Zhou, M., Chen, L., Meng, S.,
Hu,Y.,Peng,C., Yuan,M., Huang,J., Wang, Z.,Yu, J.,Gao, X., Wang, D., Yu,X., Li, L.,
…Yang, X.(2020). Effectiveness of convalescent plasma therapy in severe COVID-19
patients. Proceedings of the National Academy of Sciences, Apr 2020, 202004168.
Recuperado en: https://doi.org/10.1073/pnas.2004168117
Food and Drug Administration, USA (FDA). (2020). Investigational COVID-19
Convalescent Plasma - Emergency INDs. Recuperado en:
blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process
cber/recommendations-investigational-covid-19-convalescent-plasma
Frame, J., Verbrugge, G.P., Gill, R.G., & Pinneo, L.(1984). The use of Lassa fever
convalescent plasma in Nigeria. Transactions of the Royal Society of Tropical Medicine
and Hygiene,78(3), 319–324.
Recuperado en: https://doi.org/10.1016/0035-9203(84)90107-X
Garraud, O., Heshmati, F., Pozzetto, B., Lefrere F., Girot R., Saillol A., & Laperche, S.
(2016).Terapia con plasma contra patógenos infecciosos, a partir de ayer, hoy y mañana.
Transfusion clinique et biologique :journal de la Societe francaise de
Transfusión sanguine,23(1), 39-44.
Recuperado en: https://doi.org/10.1016/j.tracli.2015.12.003
Hung, I., To, K.K., Lee, C-K., Lee, K-L., Chan, K., Yan, W-W., ., Liu, R., Watt, C. L.,
Chan, W. M., Lai, K. Y., Koo, C. K., Buckley, T., Chow, F. L., Wong, K. K., Chan, H. S.,
Ching, C. K., Tang, B. S., Lau, C. C., Li, I. W., Liu, S. H., … Yuen, K. Y. (2009). El
tratamiento convaleciente en plasma redujo la mortalidad en pacientes con infección
grave por el virus de la influenza pandémica A (H1N1). Clinical Infectious Diseases, 52
(4), 447-456. Recuperado en: https://doi.org/10.1093/cid/ciq106
Instituto de Salud Carlos III / Centro Nacional de Epidemiología. (2020). Estudio Ene
COVID19. Estudio Nacional de Sero-Epidemiología de la infección por SARS-CoV-2 en
España. Gobierno de España, Ministerio de Ciencia e Innovación, Ministerio de Salud.
Recuperado en: https://www.mscbs.gob.es/ciudadanos/enecovid/home
Kalil, A. (2020). Treating COVID-19—Off-Label Drug Use, Compassionate Use, and
Randomized Clinical Trials During Pandemics, JAMA, 323(19), 1897–1898. Recuperado
en: https://doi.org/10.1001/jama.2020.4742
Krammer, F., & Simon, V. (2020). Serology assays to manage COVID-19. Science,
(6495),1060-1061. Recuperado en: https://doi.org/10.1126/science.abc1227
Lang, M., Som, A., Mendoza, D., Flores, E., Reid, N., Carey, D., Li, M., Witkin, A.,
Rodríguez-López, J., Shepard, J., & Little, B. (2020). Hypoxaemia related to
COVID-19: vascular and perfusion abnormalities on dual-energy CT.The Lancet
Infectious Diseases. Recuperado en: https://doi.org/10.1016/S1473-3099(20)30367-4
Li, L., Zhang, W., Hu, Y., Tong, X., Zheng, S., Yang, J., Kong,Y.,Ren.L.,Wei,Q., Mei,H.,
Hu,C., Tao,C.,Yang,R., Wang, J.,Yu,Y.,Guo, Y.,Wu,X., Xu,Z., Zeng,L., & Liu, Z.
(2020 abril). Effect of Convalescent Plasma Therapy on Time to Clinical Improvement in
Patients With Severe and Life-threatening COVID-19: A Randomized Clinical Trial.
JAMA, Published online June 03. Recuperado en: https://doi.org/10.1001/jama.2020.10044
Luke, T.C., Casadevall, A., Watowich,S., Hoffman,S.,Beigel,J.H., & Burgess,T.H.(2010).
Hark back: Passive immunotherapy for influenza and other serious infections. Critical
Care Medicine, 38(4suppl) e66-73.
Recuperado en: https://doi.org/10.1097/CCM.0b013e3181d44c1e
Lünemann, J.D, Nimmerjahn, F., & Dalakas, M.C. (2015). Inmunoglobulina intravenosa
en neurología: modo de acción y eficacia clínica. Nat Rev Neurol, 2015; 11, 80-89.
Recuperado en: https://doi.org/10.1038 / nrneurol.2014.253
Magro, C., Mulvey, J. J., Berlin, D., Nuovo, G., Salvatore, S., Harp, J.,Baxter-Stoltzfus,
A., & Laurence, J. (2020). Complement associated microvascular injury and thrombosis
in the pathogenesis of severe COVID-19 infection: A report of five cases. Translational
research: the journal of laboratory and clinical medicine, 220,1-13.
Recuperado en: https://doi.org/10.1016/j.trsl.2020.04.007
Ministerio del Poder Popular para la Salud. Venezuela. (2020). Normas para los Puestos
de Atención Social e Integral (PASI). Recuperado en:
https://drive.google.com/file/d/1ilH9MwKI6ti5NrVh291HNOlK2IRwG-eA/view
Mupapa, K., Massamba, M., Kibadi, K., Kuvula, K., Bwaka, A., Kipasa, M., Colebunders R ., & Muyembe-Tamfum, J.J. (1999). Treatment of Ebola hemorrhagic fever with blood transfusions from convalescent patients. International Scientific and Technical Committee. The Journal of Infectious Diseases, 179 (suppl 1), 18–23. Recuperado en: https://doi.org/10.1086/514298
Roback, J. D., & Guarner, J. (2020). Convalescent Plasma to Treat COVID-19: Possibilities and Challenges. JAMA, 10.1001/jama.2020.4940. Advance online publication. Recuperado en: https://doi.org/10.1001/jama.2020.4940
Ruggiero, H., PerezIsquierdo, F., Milani, H.A, Barri, A., Val, A., Maglio, F., &Tallone, J.C. (1986). Treatment of Argentine hemorrhagic fever with convalescent’s plasma 4433 cases. Pressemedicale, (París: France:1983), 15(45),2239–2242. Recuperado en: https://www.ncbi.nlm.nih.gov/pubmed/2949253
Sethuraman, N., Jeremiah, S.S, & Ryo, A,.(2020). Interpreting Diagnostic Tests for SARS-CoV-2. JAMA, 323(22), 2249–2251. Recuperado en: https://doi.org/10.1001/jama.2020.8259
Shen, C., Wang, Z., Zhao, F.,Yang,Y., Li, J.,Yuan, J., Wang, F., Li,D., Yang, M., Xing, L., Wei,J., Xiao,H., Yang,Y., Qu,J., Qing,L., Chen,Li, Xu,Z., & Liu, L. (2020).Treatment of 5 Critically Ill Patients with COVID-19 with Convalescent Plasma. JAMA, 323(16), 1582–1589. Published online March 27, 2020. Recuperado en: https://doi.org/10.1001/jama.2020.4783
Staines, H. M., Kirwan,D. E., Clark, D. J., Adams, E. R, Augustin, Y., Byrne, R.l., Cocozza M., Cubas-Atienza A., Cuevas L., Cusinato M., Davies B., Davis M., Davis P., Duvoix A., Eckersley N., Forton D., Fraser A., Garrod G., Hadcocks L., & Planche,T. (2020). Dynamics of IgG seroconversion and pathophysiology of COVID-19 infections. medRxiv 2020.06.07.20124636;
Recuperado en: https://doi.org/10.1101/2020.06.07.20124636
Valk, S.J., Piechotta, V., Chai, K.L., Doree, C., Monsef, I., Wood, E.M., Lamikanra, A., Kimber, C., McQuilten, Z., So-Osman, C., Estcourt, L.J., &Skoetz, N. (2020). Convalescent plasma or hyperimmune immunoglobulin for people with COVID‐19: a rapid review. TheCochrane Database of Systematic Reviews, (5), Artículo CD013600. Recuperado en: https://doi.org/10.1002/14651858.CD013600
Wenzhong, Liu; &Hualan, Li .(2020). COVID-19: Attacks the 1-Beta Chain of Hemoglobin and Captures the Porphyrin to Inhibit Human Heme Metabolism. ChemRxiv. Preprint. Recuperado en: https://doi.org/10.26434/chemrxiv.11938173.v8
World Health Organization. (2014-2). Virus Disease for Transfusion, as an Empirical Treatment during Outbreaks. Interim Guidance for National Health Authorities and Blood Transfusion Services. Recuperado en: https://www.who.int/csr/resources/publications/ebola/convalescent-treatment/en/
World Health Organization. Blood Regulators Network (BRN). (2014).Position Paper on Collection and Use of Convalescent Plasma or Serum as an Element in Middle East Respiratory Syndrome Coronavirus Response. Recuperado en: https://www.who.int/bloodproducts/brn/BRN_PositionPaperConvPlasmaMERSCoV_March2014.pdf?ua=1
World Health Organization.Blood Regulators Network (BRN). (2017). Position Paper on Use of Convalescent Plasma, Serum or Immune Globulin Concentrates as an Element in Response to an Emerging Virus.Recuperado en: https://www.who.int/bloodproducts/brn/2017_BRN_PositionPaper_ConvalescentPlasma.pdf?ua=1
Yeh, K-M., Chiueh, T-S., Siu, L. K., Lin, J-C., Chan, P. K., Peng, M-Y., & Chang, F-Y. (2005). Experience of using convalescent plasma for severe acute respiratory syndrome among healthcare workers in a Taiwan hospital. Journal of Antimicrobial Chemotherapy, 56(5), 919–922. Recuperado en: https://doi.org/10.1093/jac/dki346
Zhang, L., & Liu, Y. (2020). Potential interventions for novel coronavirus in China: A systematic review. Journal of Medical Virology, 92(6). Recuperado en: https://doi.org/10.1002/jmv.25707
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