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

NCT ID: NCT06052527

Last Updated: 2023-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-16

Study Completion Date

2023-10-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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COVID-19 Post-COVID-19 Syndrome Influenza

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Active Covid-19 Infection

Patients with positive SARS-CoV-2 rapid antigen test results within 60 days before the start of the study will be administered pre-defined TCM prescriptions recommended by the Autonomous Treatment System based on machine learning

Autonomous Treatment System for Covid-19, Post-Acute Sequelae of SARS-CoV-2 Infection and Influenza Based on Machine Learning

Intervention Type OTHER

A novel treatment recommendation system for Covid-19, Post-Acute Sequelae of SARS-CoV-2 Infection and Influenza, which is based on machine learning

Post-Covid-19 Syndrome

Patients with positive Covid-19 antigen test results obtained more than 60 days before the start of the study will be administered pre-defined TCM prescriptions recommended by the Autonomous Treatment System based on machine learning.

Autonomous Treatment System for Covid-19, Post-Acute Sequelae of SARS-CoV-2 Infection and Influenza Based on Machine Learning

Intervention Type OTHER

A novel treatment recommendation system for Covid-19, Post-Acute Sequelae of SARS-CoV-2 Infection and Influenza, which is based on machine learning

Influenza

Patients with negative SARS-CoV-2 rapid antigen test results and who are diagnosed with influenza will be administered pre-defined TCM prescriptions recommended by the Autonomous Treatment System based on machine learning.

Autonomous Treatment System for Covid-19, Post-Acute Sequelae of SARS-CoV-2 Infection and Influenza Based on Machine Learning

Intervention Type OTHER

A novel treatment recommendation system for Covid-19, Post-Acute Sequelae of SARS-CoV-2 Infection and Influenza, which is based on machine learning

Interventions

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Autonomous Treatment System for Covid-19, Post-Acute Sequelae of SARS-CoV-2 Infection and Influenza Based on Machine Learning

A novel treatment recommendation system for Covid-19, Post-Acute Sequelae of SARS-CoV-2 Infection and Influenza, which is based on machine learning

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

14 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheng'ai Traditional Chinese Medicine Hospital

UNKNOWN

Sponsor Role collaborator

Lizora LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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jiale xian, MHA

Role: STUDY_CHAIR

Lizora LLC

Locations

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Sheng'Ai Traditional Medicine Hospital

Kunming, Yunnan, China

Site Status

Countries

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China

Other Identifiers

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Liz2023Covid19

Identifier Type: -

Identifier Source: org_study_id