Vacinas para Coronavírus (COVID-19; SARS-COV-2): mapeamento preliminar de artigos, patentes, testes clínicos e mercado

The recent Coronavirus outbreak has sparked a worldwide pandemic. This article consists of an exploratory study to assess the existing volume of material and the potential for further technological assessment and forecast. It is used to assess the knowledge that exists in science (through articles), in technology (through patents), in clinical tests and ready for use (through vaccines available on the market). The articles were mapped on the Web of Knowledge, the patent assessment used the European Worldwide database, using the Orbit® software. 991 patents, 125 articles and 115 clinical studies were found, with only 2 explicitly referring to vaccines. The annual evolution shows an exponential growth from 2002-2004 for articles and for patents. The vast majority of clinical studies have not yet started (only 15% have been completed), showing that there is an urgent need to stimulate their maturation. There is still no vaccine on the market that is considered worldwide effective.O recente surto de Coronavírus gerou uma pandemia mundial. Este artigo consiste em um estudo exploratório para avaliar parcialmente o volume existente de material e o potencial de aprofundar futuras prospecções tecnológicas. O propósito deste estudo é o de pré-avaliar o conhecimento que existe em ciência (por meio de artigos), em tecnologia (por meio de patentes) e em testes clínicos e prontos para uso (por meio de vacinas disponíveis no mercado). Os artigos foram mapeados na Web of Knowledge, o mapeamento patentário usou a base Worldwide europeia, usando o software Orbit®. Os estudos clínicos utilizaram a base de dados dos Estados Unidos da América (EUA). Foram encontradas 991 patentes, 125 artigos e 115 estudos clínicos sendo apenas dois que se referem explicitamente a vacinas. A evolução anual mostra um crescimento exponencial a partir de 2002-2004 para artigos e para patentes. A grande maioria dos estudos clínicos nem foi ainda iniciada (apenas 15% foram completados), evidenciando que há necessidade urgente de estimular sua maturação. Não existe, no momento, no mercado, uma vacina que seja considerada efetiva mundialmente

Fármacos para COVID-19: muito além da cloroquina (testes clínicos para o coronavírus SARS-CoV-2)

This work analyzes the drugs used for patients with COVID-19 which are undergoing clinical trials and that go well beyond chloroquine. The data were obtained from the World Health Organization's International Clinical Trials Registration Platform. Geodistribution shows concentration in China, and only 5% of transnational partnerships. Clinical tests are concentrated in intermediate phases II and III. The classes of drugs go far beyond antimalarials, which have become popularly known, also comprising antivirals, anti-inflammatories, antibiotics, anticoagulants, antibodies, antifibrotics, antitumor agents, calcium channel blockers, corticosteroids, immunomodulators, immunosuppressants, enzyme inhibitors, mucolytics, vasoconstrictors and vasodilators, vitamins and mineral salts. The most tested antivirals are Ritonavir, Remdesivir, Lopinavir, Favipiravir and Arbidol, as well as their associations. Several tests combine antimalarials, antivirals and immunomodulators, the most studied being Favipiravir and Lopinavir associated with Ritonavir, Methylprednisolone, Remdesivir, Tocilizumab, Chloroquine and Hydroxychloroquine.Este trabalho analisa os fármacos utilizados para pacientes com COVID-19, que estão em fase de testes clínicos e que vão muito além da cloroquina. Os dados foram obtidos na Plataforma Internacional de Registro de Ensaios Clínicos da Organização Mundial de Saúde (OMS). A geodistribuição mostra a concentração desses fármacos na China, e apenas 5% de parcerias transnacionais. Os testes clínicos se concentram nas fases intermediárias II e III. As classes de fármacos vão além dos antimaláricos, que têm se tornado popularmente conhecidos, compreendendo também antivirais, anti-inflamatórios, antibióticos, anticoagulantes, anticorpos, antifibróticos, antitumorais, bloqueadores de canais de cálcio, corticoides, imunomoduladores, imunossupressores, inibidores de enzimas, mucolíticos, vasoconstritores e vasodilatadores, vitaminas e sais minerais. Os antivirais mais testados são Ritonavir, Remdesivir, Lopinavir, Favipiravir e Arbidol, assim como suas associações. Diversos testes combinam antimaláricos, antivirais e imunomoduladores, sendo os mais estudados Favipiravir e Lopinavir, associados com Ritonavir, Metilprednisolona, Remdesivir, Tocilizumabe, Cloroquina e Hidroxicloroquina

Evaluation of a quality improvement intervention to reduce anastomotic leak following right colectomy (EAGLE): pragmatic, batched stepped-wedge, cluster-randomized trial in 64 countries

Background Anastomotic leak affects 8 per cent of patients after right colectomy with a 10-fold increased risk of postoperative death. The EAGLE study aimed to develop and test whether an international, standardized quality improvement intervention could reduce anastomotic leaks. Methods The internationally intended protocol, iteratively co-developed by a multistage Delphi process, comprised an online educational module introducing risk stratification, an intraoperative checklist, and harmonized surgical techniques. Clusters (hospital teams) were randomized to one of three arms with varied sequences of intervention/data collection by a derived stepped-wedge batch design (at least 18 hospital teams per batch). Patients were blinded to the study allocation. Low- and middle-income country enrolment was encouraged. The primary outcome (assessed by intention to treat) was anastomotic leak rate, and subgroup analyses by module completion (at least 80 per cent of surgeons, high engagement; less than 50 per cent, low engagement) were preplanned. Results A total 355 hospital teams registered, with 332 from 64 countries (39.2 per cent low and middle income) included in the final analysis. The online modules were completed by half of the surgeons (2143 of 4411). The primary analysis included 3039 of the 3268 patients recruited (206 patients had no anastomosis and 23 were lost to follow-up), with anastomotic leaks arising before and after the intervention in 10.1 and 9.6 per cent respectively (adjusted OR 0.87, 95 per cent c.i. 0.59 to 1.30; P = 0.498). The proportion of surgeons completing the educational modules was an influence: the leak rate decreased from 12.2 per cent (61 of 500) before intervention to 5.1 per cent (24 of 473) after intervention in high-engagement centres (adjusted OR 0.36, 0.20 to 0.64; P < 0.001), but this was not observed in low-engagement hospitals (8.3 per cent (59 of 714) and 13.8 per cent (61 of 443) respectively; adjusted OR 2.09, 1.31 to 3.31). Conclusion Completion of globally available digital training by engaged teams can alter anastomotic leak rates. Registration number: NCT04270721 (http://www.clinicaltrials.gov)