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临床试验/NCT06052527
NCT06052527已完成不适用

Autonomous Covid-19, Post-Acute Sequelae of SARS-CoV-2 Infection (PASC) and Influenza Treatment System With Machine Learning in Outpatient Settings

Lizora LLC1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2023年6月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Lizora LLC
入组人数
27
试验地点
1
主要终点
Classification Accuracy

研究概览

简要总结

This is an open-tabled, one-arm observatory trial to assess the effectiveness and safety of the Autonomous Treatment System Based on Machine Learning in patients with Covid-19, Post-Acute Sequelae of SARS-CoV-2 infection and influenza.

详细描述

This study has enrolled 27 patients diagnosed with Covid-19, Post-Acute Sequelae of SARS-CoV-2 infection, and influenza. Of these patients, 26 are outpatients, and 1 is hospitalized. After screening based on the inclusion and exclusion criteria, eligible patients will receive prescriptions recommended by the Autonomous Treatment System Based on Machine Learning in this observational trial.

The objectives of this study are:

  1. To compare the classifications made by our machine learning system with those by physicians to assess the model's reliability and accuracy;
  2. To evaluate Covid-19-related hospitalizations or deaths from any cause through day 28;
  3. To determine if the machine learning system's recommended prescription alleviates symptoms of Covid-19, Post-Acute Sequelae of SARS-CoV-2 infection, and influenza;
  4. To monitor participants who tested positive for the Covid-19 for 28 days after initiating treatment, looking for potential rebound cases.

Participants will use an online application to receive the recommended prescription results and will forward these results to a physician for verification. Patients are instructed to complete the online analysis every 3 days or whenever their symptoms change, whichever comes first. They are also asked to adhere to the prescribed medication regimen. Research physicians will conduct follow-ups with patients every 3 days via phone calls. The potential treatments patients may receive include any of the following Traditional Chinese Medicine formulas: LizCovidCure-1, LizCovidCure-2, LizCovidCure-3, LizCovidCure-4, and LizCovid-5.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
14 Years 至 95 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Either male or female (14 years or older), and their COVID-19 vaccination status was not a factor for inclusion.
  • Subjects with any high-risk conditions
  • Subjects with positive sars-cov-2 rapid antigen results in 30 days
  • Subjects with post Covid-19 syndrome

排除标准

  • pregnant individuals
  • subjects with known histories of allergic reactions to medical herbs commonly used in Traditional Chinese Medicine (TCMs)

结局指标

主要结局

Classification Accuracy

时间窗: 1 Day

compare the classifications made by our machine learning system with those by physicians, to assess the model's reliability

次要结局

  • Hospitalization Rate and Death(28 Days)

研究者

发起方
Lizora LLC
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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