长COVID使人衰弱,SARS-CoV-2感染后的多系统疾病,其持续时间可能不确定。大流行已经过去四年多了,从临床试验中获得的知识很少。我们分析了ClinicalTrials.gov上的信息,发现试验的严谨性和重点差异很大,大多数人在证据不足的情况下测试非药物干预措施。我们强调正在进行的有希望的试验,并鼓励增加用于治疗长型COVID和其他与感染相关的慢性病症和疾病(IACCI)的临床试验。我们推荐一些长期COVID试验的指南:首先,具有潜在治疗作用的药物试验,应优先考虑主要干预措施,应该进行药物再利用和新药开发。第二,研究设计应该既严格又可访问,例如,可以远程进行的三盲随机试验,参与者不需要离开家园。第三,研究应该有多个疾病比较队列的IACCI,如肌痛性脑脊髓炎(ME/CFS)和自主神经障碍,并筛选这些疾病的全部症状和病理。第四,研究应考虑纳入/排除标准,着眼于代表性的公平性和广度,包括所有种族的参与者,种族,受COVID-19影响最大的性别,包括所有疾病严重程度。第五,让患者-研究人员参与研究的各个方面带来了非常有价值的观点,这将增加试验的影响.我们还鼓励开发有效的临床试验设计,包括并行研究几种疗法的方法。
Long COVID is a debilitating, multisystemic illness following a SARS-CoV-2 infection whose duration may be indefinite. Over four years into the pandemic, little knowledge has been generated from clinical trials. We analyzed the information available on ClinicalTrials.gov, and found that the rigor and focus of trials vary widely, and that the majority test non-pharmacological interventions with insufficient evidence. We highlight promising trials underway, and encourage the proliferation of clinical trials for treating Long COVID and other infection-associated chronic conditions and illnesses (IACCIs). We recommend several guidelines for Long COVID trials: First, pharmaceutical trials with potentially curative, primary interventions should be prioritized, and both drug repurposing and new drug development should be pursued. Second, study designs should be both rigorous and accessible, e.g., triple-blinded randomized trials that can be conducted remotely, without participants needing to leave their homes. Third, studies should have multiple illness comparator cohorts for IACCIs such as Myalgic Encephalomyelitis (ME/CFS) and dysautonomia, and screen for the full spectrum of symptomatology and pathologies of these illnesses. Fourth, studies should consider inclusion/exclusion criteria with an eye towards equity and breadth of representation, including participants of all races, ethnicities, and genders most impacted by COVID-19, and including all levels of illness severity. Fifth, involving patient-researchers in all aspects of studies brings immensely valuable perspectives that will increase the impact of trials. We also encourage the development of efficient clinical trial designs including methods to study several therapies in parallel.