recovery - neuro:测量认知功能障碍干预对长期COVID症状影响的平台方案

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

• ≥ 18 years of age at the time of enrollment
• PROMIS-Cog T-score < 40
• Previous suspected, probable, or confirmed SARS-CoV-2 infection, as defined by the Pan American Health Organization 疑似SARS-CoV-2感染病例-从A到C三个选项: A. Met clinical OR epidemiological criteria: a. 临床标准:急性发热和咳嗽(流感样疾病)或急性出现下列体征或症状中的任何三种或三种以上:发烧, cough, general, weakness/fatigue, headache, myalgia, sore throat, coryza, dyspnea, nausea, diarrhea, anorexia; b. 流行病学标准:接触过可能或确诊病例或与COVID-19聚集性病例有关; B. 表现为急性呼吸道感染，有发热史或实测发热≥38℃及咳嗽, with onset within the last 10 days, and who requires hospitalization; or C. Presented with no clinical signs or symptoms, 专业使用或自检SARS-CoV-2抗原快速诊断试验阳性，符合流行病学标准. Probable case of SARS-CoV-2 infection, 定义为符合上述临床标准，并且是可能或确诊病例的接触者或与COVID-19聚集性感染有关. 确诊的SARS-CoV-2感染病例-两种选择，A到B: A. 核酸扩增试验呈阳性, regardless of clinical criteria OR epidemiological criteria; or B. 符合临床和/或流行病学标准(见疑似病例A).a.)，专业使用或自检SARS-CoV-2抗原快速诊断测试呈阳性. * 5月1日前发生的疑似病例和可能病例才允许入境, 2021, and will be limited to 10% of the study population. Otherwise, confirmed cases are required.
• SARS-CoV-2感染后持续至少12周且在同意时仍存在的认知功能障碍症状
• Fluent in English or Spanish language
• Willing and able to provide informed consent, complete the intervention, complete the intervention assessments, and return for all of the necessary follow-up visits

符合以下任何条件的个体将被排除在本研究之外:

• 既往或活动的不稳定或进行性重大精神或神经疾病，无改善，可能隐藏治疗效果，与SARS-CoV-2感染无关, at the investigator's discretion, including, but not limited to, the following examples: a. 进行性神经退行性疾病，如阿尔茨海默病、帕金森病等. b. 过去发生的外伤性脑损伤仍与活跃的脑震荡后症状有关. Uncontrolled seizure disorder, 例如，在过去一年中至少有一次癫痫发作，并经临床判断. Post-stroke deficits that may interfere with assessment, such as language or communication difficulties, aphasia, etc. e. Formal thought disorders, such as schizophrenia, etc. f. 任何神经精神或神经障碍在过去六个月内未得到控制或可能干扰评估, at discretion of the investigator
• 已知既往诊断为肌痛性脑脊髓炎/慢性疲劳综合征, not related to SARS-CoV-2 infection
• 已知急性活动性SARS-CoV-2感染距离同意时间≤4周
• 目前使用的对症治疗包括处方或非法兴奋剂, amantadine, N-methyl-D-aspartate receptor antagonists (e.g., memantine, dissociative drugs)
• 目前使用兴奋剂治疗任何pasc相关症状
• Current diagnosis of alcohol and substance use disorders a. 如果在研究入组前达到并保持至少12个月的戒断，先前的使用障碍是可以接受的
• 视觉、听觉和运动功能不足，无法参与干预和评估
• Known pregnancy
• 目前或最近(过去2个月内)使用干预措施*
• 已知对干预成分或比较物过敏/敏感/超敏*
• 目前正在接受/使用另一项临床试验的干预措施，例如另一项RECOVER试验
• Any condition that would make the participant, in the opinion of the investigator, unsuitable for the study
  • 现场研究者有权决定参与者是否因认知障碍过大而不能参加，是否应转介进行临床评估. 每个附录中都列出了干预附录的排除情况. *如果在入组时只有一个干预阑尾打开，则相关, though exclusion may be qualified in the appendix. If multiple intervention appendices are open, 根据干预附录中列出的禁忌症，参与者可能被排除在任何干预附录之外, current use of intervention, 或已知过敏/敏感/超敏，仍然有资格进行其余的干预附件.