{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,30]],"date-time":"2025-07-30T15:09:05Z","timestamp":1753888145507,"version":"3.41.2"},"reference-count":32,"publisher":"FapUNIFESP (SciELO)","license":[{"start":{"date-parts":[[2020,1,1]],"date-time":"2020-01-01T00:00:00Z","timestamp":1577836800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2020,1,1]],"date-time":"2020-01-01T00:00:00Z","timestamp":1577836800000},"content-version":"am","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2020,1,1]],"date-time":"2020-01-01T00:00:00Z","timestamp":1577836800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Rev. bras. epidemiol."],"abstract":"<jats:p>RESUMO:  Objetivo:  Descrever as caracter\u00edsticas metodol\u00f3gicas e de boas pr\u00e1ticas em pesquisa dos estudos de interven\u00e7\u00e3o para COVID-19 desenvolvidos no Brasil nos primeiros meses da pandemia.  M\u00e9todos:  Revisamos o boletim da Comiss\u00e3o Nacional de \u00c9tica em Pesquisa - edi\u00e7\u00e3o especial Coronav\u00edrus (CONEP-COVID) (28 de maio de 2020) e as bases International Clinical Trials Registry Platform (ICTRP), ClinicalTrials.gov e Registro Brasileiro de Ensaios Cl\u00ednicos (ReBEC) para identificar estudos registrados no Brasil que avaliassem interven\u00e7\u00f5es de tipo de medicamento, terapia biol\u00f3gica ou vacinas. Descrevemos as caracter\u00edsticas metodol\u00f3gicas e calculamos o poder para diferentes magnitudes de efeito.  Resultados:  Foram inclu\u00eddos 62 estudos, 55 identificados no site da CONEP e mais sete nas bases de registro. As interven\u00e7\u00f5es medicamentosas mais frequentemente testadas nesses estudos foram: cloroquina\/hidroxicloroquina, azitromicina, plasma convalescente, tocilizumabe, sarilumabe, eculizumabe, vacina, corticoides, anticoagulantes, n-acetilciste\u00edna, nitazoxanida, ivermectina e lopinavir\/ritonavir. De 22 protocolos publicados at\u00e9 maio de 2020 nas bases de registro, 18 (82%) eram ensaios cl\u00ednicos randomizados e 13 (59%) tinham grupo controle adequado. Entretanto, nove (41%) eram mascarados e somente cinco (24%) inclu\u00edam pacientes diagnosticados com teste de laborat\u00f3rio espec\u00edfico (por exemplo, transcri\u00e7\u00e3o reversa seguida de rea\u00e7\u00e3o em cadeia da polimerase - RT-PCR). A maioria desses trabalhos teria poder &gt; 80% apenas para identificar grandes tamanhos de efeito. Em seguimento prospectivo, observamos que 60% dos estudos dispon\u00edveis na CONEP at\u00e9 maio de 2020 n\u00e3o estavam em nenhuma das plataformas de registro (ICTRP\/ReBEC\/ClinicalTrials) at\u00e9 o dia 21 de julho de 2020.  Conclus\u00e3o:  As interven\u00e7\u00f5es avaliadas durante a resposta brasileira em pesquisa refletem iniciativas internacionais, por\u00e9m com distribui\u00e7\u00e3o diferente, tendo n\u00famero elevado de estudos que avaliam hidroxicloroquina\/cloroquina. Limita\u00e7\u00f5es no delineamento metodol\u00f3gico e planejamento amostral representam desafios que podem afetar o alcance dos trabalhos.<\/jats:p>","DOI":"10.1590\/1980-549720200104","type":"journal-article","created":{"date-parts":[[2020,9,25]],"date-time":"2020-09-25T11:15:27Z","timestamp":1601032527000},"source":"Crossref","is-referenced-by-count":5,"title":["Avalia\u00e7\u00e3o da resposta inicial de desenvolvimento de ensaios cl\u00ednicos para COVID-19 no Brasil"],"prefix":"10.1590","volume":"23","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4434-748X","authenticated-orcid":false,"given":"Tatiane Bomfim","family":"Ribeiro","sequence":"first","affiliation":[{"name":"Universidade de S\u00e3o Paulo,  Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7099-654X","authenticated-orcid":false,"given":"Talita Aona","family":"Mazotti","sequence":"additional","affiliation":[{"name":"Universidade de S\u00e3o Paulo,  Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3019-2851","authenticated-orcid":false,"given":"Nayara Aparecida de Oliveira","family":"Silva","sequence":"additional","affiliation":[{"name":"Universidade Federal de S\u00e3o Paulo,  Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8756-8699","authenticated-orcid":false,"given":"Airton Tetelbom","family":"Stein","sequence":"additional","affiliation":[{"name":"Universidade Federal de Ci\u00eancias da Sa\u00fade de Porto Alegre,  Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1134-1930","authenticated-orcid":false,"given":"Fredi Alexander","family":"Diaz-Quijano","sequence":"additional","affiliation":[{"name":"Universidade de S\u00e3o Paulo,  Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8613-7953","authenticated-orcid":false,"given":"Daniela Oliveira de","family":"Melo","sequence":"additional","affiliation":[{"name":"Universidade Federal de S\u00e3o Paulo,  Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"530","published-online":{"date-parts":[[2020]]},"reference":[{"year":"2020","series-title":"Oxford COVID-19 vaccine to begin phase II\/III human trials","key":"ref1"},{"key":"ref2","article-title":"\u201cA completely new culture of doing research.\u201d Coronavirus outbreak changes how scientists communicate","author":"Kupferschmidt K","year":"2020","journal-title":"Science"},{"issue":"4","key":"ref3","doi-asserted-by":"crossref","first-page":"24","DOI":"10.4067\/S0718-27242018000400024","article-title":"Innovation studies in Latin America: a bibliometric analysis","volume":"13","author":"Tello Gamarra J","year":"2018","journal-title":"J Technol Manag Innov 2018"},{"journal-title":"O Globo","article-title":"Sa\u00fade e CNPq investem em pesquisas sobre o novo coronav\u00edrus","year":"2020","key":"ref4"},{"key":"ref5","article-title":"Brasil: o novo epicentro da pandemia de coronav\u00edrus?","author":"Barrucho L","year":"2020","journal-title":"BBC"},{"journal-title":"Di\u00e1rio Oficial da Uni\u00e3o","article-title":"Resolu\u00e7\u00e3o n\u00ba 196\/96, de 10 de outubro de 1996","year":"1996","key":"ref6"},{"year":"2012","series-title":"Resolu\u00e7\u00e3o n\u00ba 466. 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