Clinical Trials on COVID-19: What is Being Researched in the United States?

Isla Camilla Carvalho Laureano, A. Leite Cavalcanti
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Abstract

The emergence of Coronavirus Disease 2019 (COVID-19) in late 2019 has brought great challenges to public health worldwide and, to date, there is no specific approved therapeutic protocol. Therefore, this chapter will analyze types of intervention for use in patients with COVID-19 developed by American researchers from records made on the Clinical Trials platform. For the search strategy, keywords “COVID-19” in the “Condition or Disease” section and “United States” in the “Country” section were used. No filters were applied. Data were descriptively analyzed. In total, 1,182 studies were obtained, of which 496 met the eligibility criteria. Sample size ranged from 1 to 10,000 participants. Most studies involved the age group of 18–64 years (48.6%). As for design, randomized type (80.5%), parallel (75.6%), open designs (38.7%) and those with therapeutic purpose (88.3%) were more frequent. Most clinical trials used the two-arm trial (67.3%), researched drugs (64.8%), used placebo (55.2%) and were sponsored by pharmaceutical/biotechnology companies (35.4%). Clinical trials developed by American researchers on COVID-19 involve adult and elderly participants, with predominance of randomized, parallel and open design, for therapeutic purposes and mostly evaluated immunosuppressants or combinations of antivirals/immunosuppressants. The drugs and biological products Remdesivir, Baricitinib in combination with Remdesivir, Bamlanivimab and Etesevimab, REGEN-COV and COVID-19 convalescent plasma were also used, authorized for emergency use.
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COVID-19临床试验:美国正在研究什么?
2019年底出现的2019冠状病毒病(COVID-19)给全球公共卫生带来了巨大挑战,迄今为止,还没有特定的批准治疗方案。因此,本章将分析美国研究人员根据临床试验平台的记录开发的用于COVID-19患者的干预措施类型。对于搜索策略,在“病症或疾病”部分使用关键词“COVID-19”,在“国家”部分使用关键词“美国”。没有使用过滤器。对数据进行描述性分析。总共获得了1182项研究,其中496项符合资格标准。样本量从1人到10000人不等。大多数研究涉及18-64岁年龄组(48.6%)。在设计方面,随机型(80.5%)、平行型(75.6%)、开放式(38.7%)和治疗型(88.3%)更为常见。大多数临床试验采用双组试验(67.3%),研究药物(64.8%),使用安慰剂(55.2%),由制药/生物技术公司赞助(35.4%)。美国研究人员开展的新冠肺炎临床试验涉及成人和老年人,以治疗为目的,以随机、平行和开放设计为主,主要评估免疫抑制剂或抗病毒药物/免疫抑制剂联合使用。药物和生物制品Remdesivir、Baricitinib联合Remdesivir、Bamlanivimab和Etesevimab、REGEN-COV和COVID-19恢复期血浆也被批准用于紧急使用。
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