{"id":7543,"date":"2020-06-16T12:27:07","date_gmt":"2020-06-16T12:27:07","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=7543"},"modified":"2021-12-10T19:06:29","modified_gmt":"2021-12-10T19:06:29","slug":"convalescent-plasma-treatment-for-covid-19-under-clinical-trial","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/pt\/convalescent-plasma-treatment-for-covid-19-under-clinical-trial\/","title":{"rendered":"Tratamento de Plasma Convalescente para COVID-19 sob Ensaio Cl\u00ednico"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_45_1 counter-flat ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\">Tabela de Conte\u00fados<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" area-label=\"ez-toc-toggle-icon-1\"><label for=\"item-69f62c1f0c904\" aria-label=\"Table of Content\"><span style=\"display: flex;align-items: center;width: 35px;height: 30px;justify-content: center;direction:ltr;\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewbox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewbox=\"0 0 24 24\" version=\"1.2\" baseprofile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/label><input  type=\"checkbox\" id=\"item-69f62c1f0c904\"><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1' ><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/convalescent-plasma-treatment-for-covid-19-under-clinical-trial\/#Clinical_Trials_on_Convalescent_Plasma_Therapy\" title=\"Ensaios cl\u00ednicos em Terapia Plasm\u00e1tica Convalescente\">Ensaios cl\u00ednicos em Terapia Plasm\u00e1tica Convalescente<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/convalescent-plasma-treatment-for-covid-19-under-clinical-trial\/#USFDAs_Directive_on_Investigational_Clinical_Use_of_Convalescent_Plasma\" title=\"Diretiva da USFDA sobre o uso cl\u00ednico investigacional do Plasma Convalescente\">Diretiva da USFDA sobre o uso cl\u00ednico investigacional do Plasma Convalescente<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/convalescent-plasma-treatment-for-covid-19-under-clinical-trial\/#Mechanism_of_Convalescent_Plasma_Infusion_Therapy\" title=\"Mecanismo da Terapia de Infus\u00e3o de Plasma Convalescente\">Mecanismo da Terapia de Infus\u00e3o de Plasma Convalescente<\/a><\/li><\/ul><\/nav><\/div>\n<p><em>Mahasweta Pal, <a href=\"https:\/\/kolabtree.com\/services\/medical-writing\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=ConvalescentPlasma\">escritor m\u00e9dico freelance<\/a> em Kolabtree, escreve sobre os ensaios cl\u00ednicos em andamento para testar a efic\u00e1cia do tratamento com plasma convalescente para a COVID-19.\u00a0\u00a0<\/em><\/p>\n<p>At\u00e9 hoje, Remdesivir e Favipiravir continuam sendo os \u00fanicos medicamentos dispon\u00edveis com um status de emerg\u00eancia aprovado pela FDA para tratar a doen\u00e7a coronav\u00edrus, que s\u00e3o aprovados e acess\u00edveis apenas em alguns pa\u00edses (Estados Unidos, It\u00e1lia, China e Jap\u00e3o). Al\u00e9m disso, a hidroxicloroquina e a cloroquina, que eram os medicamentos mais freq\u00fcentemente utilizados contra infec\u00e7\u00f5es pelo SARS-COV-2, foram associados a <a href=\"https:\/\/www.fda.gov\/media\/137250\/download\">problemas graves de ritmo card\u00edaco<\/a> e outro novo estudo concluiu que, embora sejam eficazes contra as doen\u00e7as auto-imunes e a mal\u00e1ria, eles <a href=\"https:\/\/www.thelancet.com\/journals\/lancet\/article\/PIIS0140-6736(20)31180-6\/fulltext\">n\u00e3o poderia mostrar qualquer benef\u00edcio ameliorat\u00f3rio significativo contra a infec\u00e7\u00e3o pelo coronav\u00edrus<\/a>. At\u00e9 mesmo o bra\u00e7o de ensaio SOLIDARIEDADE da Organiza\u00e7\u00e3o Mundial da Sa\u00fade baseado em hidroxicloroquina foi interrompido.<\/p>\n<p>Em v\u00e1rios pa\u00edses, a popula\u00e7\u00e3o de pacientes compreende casos assintom\u00e1ticos de COVID-19 e a necessidade de tratamentos contra casos leves e graves de <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/covid-19?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=ConvalescentPlasma\">COVID-19<\/a> aumentou consideravelmente, o que levou as grandes empresas farmac\u00eauticas a considerar outros tratamentos sob testes cl\u00ednicos, dada a emergente crise global.<\/p>\n<p>Estudos anteriores sobre o tratamento de infec\u00e7\u00f5es por coronav\u00edrus, tais como SARS, MERS e outros <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC4264590\/\" target=\"_blank\" rel=\"noopener noreferrer\">doen\u00e7as virais, incluindo o Ebolavirus<\/a> e a gripe H1N1 A mostraram que <strong>infus\u00e3o de plasma convalescente<\/strong> \u00e9 um <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC7229974\/\" target=\"_blank\" rel=\"noopener noreferrer\">solu\u00e7\u00e3o provis\u00f3ria vi\u00e1vel<\/a> for treating patients with life-threatening manifestations of severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) coronavirus disease. Therefore, here is a brief look at how this biological intervention is helping in the pandemic management in <a href=\"https:\/\/www.kolabtree.com\/blog\/pt\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">sa\u00fade<\/a> systems worldwide.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Clinical_Trials_on_Convalescent_Plasma_Therapy\"><\/span>Ensaios cl\u00ednicos em Terapia Plasm\u00e1tica Convalescente<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Nos 96 ensaios em execu\u00e7\u00e3o global, o plasma convalescente (CP) contendo anticorpos para o SARS-CoV-2 est\u00e1 sendo <a href=\"https:\/\/www.fda.gov\/vaccines-blood-biologics\/investigational-new-drug-ind-or-device-exemption-ide-process-cber\/recommendations-investigational-covid-19-convalescent-plasma\">estudado como um tratamento investigativo<\/a> para pacientes com COVID-19. O tratamento com CP ou imunoglobulina hiperimune tem sido restrito principalmente a projetos com um \u00fanico bra\u00e7o. At\u00e9 agora, <a href=\"https:\/\/clinicaltrials.gov\/ct2\/results?term=convalescent&amp;cond=COVID-19&amp;flds=abcht&amp;Search=Apply&amp;recrs=b&amp;recrs=a&amp;recrs=f&amp;recrs=d&amp;recrs=e&amp;age_v=&amp;gndr=&amp;type=&amp;rslt=&amp;fund=2&amp;fund=3\">56200+ pacientes<\/a> foram recrutados para testes enquanto o recrutamento permanece aberto na maioria dos centros. A medida de resultado mais comum em cada ensaio \u00e9 a mudan\u00e7a na pontua\u00e7\u00e3o da Avalia\u00e7\u00e3o Sequencial de Falhas Org\u00e2nicas (SOFA) medida 1, 3, 7, e 28 dias ap\u00f3s a administra\u00e7\u00e3o da CP no Dia 0 do ensaio. Os crit\u00e9rios de inclus\u00e3o para ensaios de PC s\u00e3o pacientes adultos gravemente doentes, pacientes com complica\u00e7\u00f5es moderadamente graves, incluindo insufici\u00eancia respirat\u00f3ria e\/ou multissist\u00eamica, e pacientes com uma apresenta\u00e7\u00e3o cl\u00ednica moderada, mas com comorbidades a longo prazo, incluindo diabetes, hipertens\u00e3o, ou condi\u00e7\u00f5es reumat\u00f3ides.<\/p>\n<p><strong>Um estudo cr\u00edtico envolvendo 10 pacientes gravemente doentes da COVID-19 de 3 hospitais diferentes em Wuhan sugeriu que a transfus\u00e3o de CP de alta intensidade pode neutralizar efetivamente a SRA-CoV-2, levando a respostas inflamat\u00f3rias impedidas e melhorando as condi\u00e7\u00f5es dos sintomas sem eventos adversos graves.<\/strong><\/p>\n<p>In\u00edcio <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC7101507\/\">Estudos da Fase I<\/a> realizado em v\u00e1rios hospitais em toda a China concluiu que a administra\u00e7\u00e3o de CP melhorou os sintomas respirat\u00f3rios em 3-5 dias ap\u00f3s a transfus\u00e3o. Em <a href=\"https:\/\/jamanetwork.com\/journals\/jama\/fullarticle\/2763983\">outro estudo<\/a>Os pacientes tinham melhorado os escores SOFA e reduzido a carga viral ap\u00f3s receberem o PC combinado com metilprednisolona, ventila\u00e7\u00e3o mec\u00e2nica e agentes antivirais. O tratamento foi capaz de proporcionar recupera\u00e7\u00e3o da SDRA em 12 dias, mostrando assim a aplicabilidade da PC em uma coorte de pequenos pacientes criticamente doentes com COVID-19 e SDRA.<\/p>\n<p>Um <a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04332835\">julgamento em andamento na Col\u00f4mbia<\/a>\u00a0est\u00e1 testando a efic\u00e1cia do plasma convalescente com hidroxicloroquina versus hidroxicloroquina em pacientes internados com COVID-19. Os investigadores est\u00e3o procurando avaliar as mudan\u00e7as na carga viral em per\u00edodos de 1, 4, 7, 14 e 28 dias, e o desenvolvimento de anticorpos IgM e IgG como medidas de resultado prim\u00e1rio e redu\u00e7\u00e3o do per\u00edodo de hospitaliza\u00e7\u00e3o e admiss\u00e3o na UTI como medida de resultado secund\u00e1rio. O NIH tamb\u00e9m tem <a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04360278\">iniciou um ensaio cl\u00ednico<\/a> para coletar plasma de pacientes adultos que se recuperaram da doen\u00e7a. Os doadores de plasma interessados tamb\u00e9m podem analisar este recurso nacional pela equipe de sa\u00fade p\u00fablica e resposta a pandemias do NIH e dos EUA. <a href=\"https:\/\/www.uscovidplasma.org\/\">dedicados aos centros m\u00e9dicos<\/a> permitindo a coleta segura de plasma.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"USFDAs_Directive_on_Investigational_Clinical_Use_of_Convalescent_Plasma\"><\/span>Diretiva da USFDA sobre o uso cl\u00ednico investigacional do Plasma Convalescente<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>O tratamento deve ser administrado apenas como uma interven\u00e7\u00e3o de emerg\u00eancia atrav\u00e9s de ensaios cl\u00ednicos, Aplica\u00e7\u00f5es de Acesso Expandido IND (a disposi\u00e7\u00e3o da FDA para <a href=\"https:\/\/www.fda.gov\/vaccines-blood-biologics\/development-approval-process-cber\/expanded-access-experimental-biologics\">pacientes que n\u00e3o puderam ser inclu\u00eddos em ensaios cl\u00ednicos<\/a>), e o IND de Emerg\u00eancia de Paciente \u00danico (COVID-19 pacientes exclu\u00eddos dos ensaios, mas em s\u00e9rias condi\u00e7\u00f5es de risco de vida) solicitado pelos m\u00e9dicos chefes do hospital ou centro m\u00e9dico.<\/p>\n<p>O USFDA \u00e9 rigoroso com a administra\u00e7\u00e3o da PC porque esses estudos cl\u00ednicos representam o risco de expor os pacientes a ant\u00edgenos potencialmente imunog\u00eanicos que complicar\u00e3o futuras transfus\u00f5es, e colocar\u00e3o os pacientes em risco de rea\u00e7\u00f5es transfusionais. Al\u00e9m disso, o uso de plasma padr\u00e3o como bra\u00e7o de controle, que carrega muitos dos mesmos riscos de PC mas nenhum de seus benef\u00edcios, pode mascarar alguns dos riscos de uso de PC que poderiam ser detectados de outra forma.<\/p>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"aligncenter size-full wp-image-9784\" src=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/06\/gr1_lrg.jpg\" alt=\"\" width=\"787\" height=\"471\" srcset=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/06\/gr1_lrg.jpg 787w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/06\/gr1_lrg-300x180.jpg 300w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/06\/gr1_lrg-16x10.jpg 16w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/06\/gr1_lrg-300x180@2x.jpg 600w\" sizes=\"(max-width: 787px) 100vw, 787px\" \/><\/p>\n<p>&nbsp;<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Mechanism_of_Convalescent_Plasma_Infusion_Therapy\"><\/span>Mecanismo da Terapia de Infus\u00e3o de Plasma Convalescente<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><a href=\"https:\/\/onlinelibrary.wiley.com\/doi\/full\/10.1111\/trf.15843\">Componentes sangu\u00edneos convalescentes<\/a> s\u00e3o derivados do soro ou sangue total de pacientes que apresentaram recupera\u00e7\u00e3o da infec\u00e7\u00e3o espec\u00edfica (neste caso COVID-19) e s\u00e3o considerados como a fonte de anticorpos neutralizantes da SRA-CoV-2. Historicamente, a imunoterapia passiva tem envolvido sangue total convalescente, plasma convalescente, imunoglobulina humana combinada para administra\u00e7\u00e3o intravenosa ou intramuscular, imunoglobulina humana de alto teor e anticorpos policlonais ou monoclonais. Entretanto, o plasma coletado por af\u00e9rese \u00e9 atualmente a terapia preferida. Os produtos sangu\u00edneos convalescentes t\u00eam um longo hist\u00f3rico de seguran\u00e7a; entretanto, eles podem aumentar o risco de aumento de infec\u00e7\u00e3o dependente de anticorpos (ADE), um fen\u00f4meno que pode tornar uma pessoa suscet\u00edvel \u00e0 infec\u00e7\u00e3o com outros v\u00edrus na presen\u00e7a de anticorpos.<\/p>\n<p>Apesar da evid\u00eancia de longa data do uso de PC ou imunoglobulina hiperimune, sua efic\u00e1cia cl\u00ednica permanece pouco clara com conclus\u00f5es fracas, provavelmente porque a PC foi usada apenas em situa\u00e7\u00f5es cr\u00edticas, durante epidemias\/pand\u00eamicas maci\u00e7as, exigindo a\u00e7\u00f5es imediatas. A efic\u00e1cia da terapia de PC parece ser diferente dependendo dos protocolos patog\u00eanicos e de tratamento (por exemplo, tempo, volume e dosagem da administra\u00e7\u00e3o).<\/p>\n<p>Uma vez que este \u00e9 um dos poucos tratamentos vi\u00e1veis dispon\u00edveis sob a aplica\u00e7\u00e3o contra o NCoV de 2019, h\u00e1 uma necessidade iminente de que os governos formulem diretrizes de pr\u00e1ticas de sa\u00fade. Diretrizes que garantam a biosseguran\u00e7a dos produtos medicinais e biol\u00f3gicos coletados, seu armazenamento e seguran\u00e7a geral, e a preven\u00e7\u00e3o da contamina\u00e7\u00e3o ainda n\u00e3o foram estabelecidas. <a href=\"https:\/\/onlinelibrary.wiley.com\/doi\/abs\/10.1111\/vox.12964\">Um coment\u00e1rio chave do USFDA em colabora\u00e7\u00e3o com pesquisadores de outros importantes COVID-19<\/a> institui\u00e7\u00f5es tamb\u00e9m destaca a necessidade de pa\u00edses de baixa e m\u00e9dia renda assegurarem que um suprimento adequado de componentes sangu\u00edneos de qualidade e seguros seja mantido para transfus\u00e3o, o que \u00e9 essencial para atender \u00e0s necessidades prim\u00e1rias de sa\u00fade da popula\u00e7\u00e3o. As respostas \u00e0 epidemia COVID-19 restabelecem a import\u00e2ncia da constru\u00e7\u00e3o de um sistema nacional de sangue organizado e sustent\u00e1vel, enquanto s\u00e3o tomadas medidas para fornecer plasma convalescente COVID-19 adequadamente coletado, testado e processado para uso cl\u00ednico investigacional.<\/p>\n<p><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC7243039\/\">O uso imediato do plasma convalescente<\/a> permite um m\u00e9todo promissor de gerenciamento de pacientes COVID-19 enquanto vacinas e tratamentos espec\u00edficos s\u00e3o avaliados e trazidos \u00e0 escala. CP de doadores que se recuperaram da COVID-19 \u00e9 considerado como o mais promissor quando usado como profilaxia ou quando administrado logo ap\u00f3s o in\u00edcio dos sintomas (dentro de 14 dias). A imunidade \u00e9 considerada como durando de semanas a meses.<\/p>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>Mahasweta Pal, freelance medical writer at Kolabtree, writes about ongoing clinical trials to test the efficacy of convalescent plasma treatment for COVID-19.\u00a0\u00a0 To date, Remdesivir and Favipiravir remain the only available medications with an emergency FDA-approved status to treat coronavirus disease, which are approved and accessible only in a few countries (United States, Italy, China,<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/pt\/convalescent-plasma-treatment-for-covid-19-under-clinical-trial\/\" title=\"Leia mais\">Leia mais<\/a><\/div>","protected":false},"author":32,"featured_media":7804,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[305,558,443,435],"tags":[569,570,531,571],"acf":[],"yoast_head":"<!-- This site is optimized with the 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