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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06052527
Other study ID # Liz2023Covid19
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 16, 2023
Est. completion date October 1, 2023

Study information

Verified date December 2023
Source Lizora LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date October 1, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers No
Gender All
Age group 14 Years to 95 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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

Locations

Country Name City State
China Sheng'Ai Traditional Medicine Hospital Kunming Yunnan

Sponsors (2)

Lead Sponsor Collaborator
Lizora LLC Sheng'ai Traditional Chinese Medicine Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Symptom Alleviation Days of symptom disappearance 28 Days
Other Re-infection Cases Number of cases with recurrence-infection after treatment 28 days
Primary Classification Accuracy compare the classifications made by our machine learning system with those by physicians, to assess the model's reliability 1 Day
Secondary Hospitalization Rate and Death we assess Covid-19-related hospitalization or death from any cause through day 28 28 Days
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