Avaliação da resposta inicial de desenvolvimento de ensaios clínicos para COVID-19 no Brasil

Ribeiro, Tatiane Bomfim; Mazotti, Talita Aona; Silva, Nayara Aparecida de Oliveira; Stein, Airton Tetelbom; Díaz-Quijano, Fredi Alexander; Melo, Daniela Oliveira de

doi:10.1590/1980-549720200104

Cited by 8 publications

(4 citation statements)

References 17 publications

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“…Após a triagem de títulos e resumos, 25 estudos foram analisados quanto aos critérios de inclusão e 16 foram excluídos. Os artigos foram excluídos por não apresentarem o desenho de estudo previamente definido Campos, Fulco, et al, 2020;Chitsike & Duerksen-Hughes, 2021;Cicka & Sukhatme, 2021;Duru et al, 2021;García-Álvarez & García-Vigil, 2020;Kelleni, 2020Kelleni, , 2021Lisi et al, 2020;Martins-Filho et al, 2020;Mostafa et al, 2020;Olagunju et al, 2021;Paumgartten et al, 2020;Rajoli et al, 2020;Ribeiro et al, 2021).…”

Section: Resultsunclassified

Uso de ivermectina e nitazoxanida para tratamento e profilaxia da COVID-19: Uma revisão sistemática

Santos

Neto²,

Rocha³

et al. 2022

RSD

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Objetivos: Revisar sistematicamente a literatura científica acerca das evidências sobre o uso de ivermectina e nitazoxanida como tratamento e profilaxia para a COVID-19. Metodologia: Esta revisão sistemática foi desenvolvida de acordo com o Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). As bases bibliográficas PubMed, Lilacs e SciELO foram pesquisadas em 14 de outubro de 2021 para identificar estudos que avaliaram o uso de ivermectina e nitazoxanida para tratamento ou profilaxia de casos confirmados ou suspeitos de COVID-19. Resultados: Foram recuperados 105 artigos, dos quais 9 foram incluídos para a revisão final, quatro ensaios clínicos randomizados, um ensaio clínico não randomizado, uma coorte retrospectiva, um estudo transversal, uma série de casos e um relato de caso. A maioria dos estudos eram do Brasil, Egito e México, avaliaram a nitazoxanida e abordaram o tratamento da doença. Conclusões: Não existem evidências científicas suficientemente robustas para apoiar o tratamento e/ou a profilaxia com a ivermectina e nitazoxanida para a COVID-19. Apesar dos resultados encontrados não apontarem um risco aumentado de eventos adversos aos medicamentos analisados, não se deve presumir que seu uso é isento de riscos e estes devem ser usados de maneira racional.

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Section: Resultsunclassified

Uso de ivermectina e nitazoxanida para tratamento e profilaxia da COVID-19: Uma revisão sistemática

Santos

Neto²,

Rocha³

et al. 2022

RSD

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“…A previous review of protocols published in Brazil, in May 2020, described a large interest in hydroxychloroquine, with its use in combination and as a comparator (9). During the pandemic outbreak, many hospitals started using it relying on compassionate use, and at that time hydroxychloroquine was still being tested, and its effect was uncertain.…”

Section: Discussionmentioning

confidence: 99%

Pooled evidence precision of clinical trials on hydroxychloroquine for Covid-19 treatment was stabilized eight months after the outbreak

Ribeiro,

Ramirez,

Melo

et al. 2024

Preprint

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OBJECTIVE At the beginning of 2020, hydroxychloroquine showed promising in vitro activity for Covid-19 and several studies were oriented to assess its safety and efficacy. However, after a few months, hydroxychloroquine has proved ineffective. The randomized controlled trials (RCTs) developed quickly and in different settings represent the scientific community capacity to assess drug repositioning effectiveness during a sanitary crisis. Therefore, a critical evaluation of the evidence generated can guide future efforts in analogous situations. We aimed to analyze the RCTs assessing the efficacy of hydroxychloroquine in treating Covid-19, describe their internal validity and power, and evaluate their contribution to the precision of the combined evidence for assessing the mortality outcome. STUDY DESIGN AND SETTINGS This meta-research included RCTs assessing hydroxychloroquine to treat patients diagnosed with Covid-19. It was part of an umbrella systematic review of methods/meta-research (PROSPERO: CRD42022360331) that included a comprehensive search in MEDLINE, EMBASE, Cochrane Library, and the Latin America Database - Lilacs. We retrieved studies published until January 10th, 2022. The risk of bias was assessed using Cochrane Risk of Bias (RoB) 2.0. We analyzed methodology of the studies, precision and random error change through time from pooled evidence, study comparators, patient important outcome, power in different magnitude of effects proxy. RESULTS A total of 22 RCT were included, from that 17 (77%) assessed hospitalized patients and five (23%) outpatients setting. Mortality was related as primary endpoint in only four studies, however half of the studies included composite endpoints including mortality as a component. The internal validity analysis using RoB2 found that eight studies (36%) had a high risk of bias. Only one study had sufficient power to evaluate a moderate magnitude of effect (RR = 0,7 on mortality). The standard error to evaluate efficacy on mortality did not change appreciably after October 2020. From Oct 2020 to Dec 2021, 18 additional studies were published with 2,429 patients recruited. CONCLUSION This meta-research highlights the impact that collaborative, and network scientific research have on informing clinical decision-making. Duplicate efforts create research waste as precision analysis shows that after October 2020, there was not appreciably changes in the precision of the pooled RCT evidence to estimate the hydroxychloroquine effect on mortality.

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“…Um exemplo é a Universidade de Oxford, que em poucos meses, após o início do desenvolvimento das vacinas, passou a ser tratada em humanos. Nesse sentido, todos os países foram desafiados para a geração rápida de políticas de saúde, baseadas em evidência e eficientes na mitigação de danos (RIBEIRO et al, 2020).…”

Section: Introductionunclassified

Vacinas Contra a Covid-19: Um Panorama dos Imunizantes Desenvolvidos no Cenário Mundial

Cruz

Silva

Rezende

et al. 2021

RFSA

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Avaliação da resposta inicial de desenvolvimento de ensaios clínicos para COVID-19 no Brasil

Cited by 8 publications

References 17 publications

Uso de ivermectina e nitazoxanida para tratamento e profilaxia da COVID-19: Uma revisão sistemática

Uso de ivermectina e nitazoxanida para tratamento e profilaxia da COVID-19: Uma revisão sistemática

Pooled evidence precision of clinical trials on hydroxychloroquine for Covid-19 treatment was stabilized eight months after the outbreak

Vacinas Contra a Covid-19: Um Panorama dos Imunizantes Desenvolvidos no Cenário Mundial

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