Treatment of Non-severe Covid-19 Outpatients With Xagrotin, Phase 3

Study Overview
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Brief Summary
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This is an interventional, multi-center, randomized study. Adults with confirmed covid-19 disease not more than 10 days before enrollment date will be recruited (n=1000). Patients in same condition who get treated with standard of care will be randomly assigned to the control group (n=1000), and patients in same condition who get treated with standard of care will be randomly assigned to the placebo group (n=1000). The investigators analyze the effect of Xagrotin, and also investigate impact of different characteristics for instance gender, age, duration of disease, smoking habits and concomitant diseases on the outcome.

Detailed Description
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An interventional, multi-center, randomized study that will performe in an outpatient setting (n=1000). Adults with confirmed covid-19 disease not more than 10 days before enrollment date will be recruited. Patients in same condition who had treated with standard of care will randomly assign to the control group (n=1000), and patients in same condition who get treated with standard of care will be randomly assigned to the placebo group (n=1000). The investigators analyze the effect of Xagrotin, and also investigate impact of different characteristics for instance gender, age, duration of disease, smoking habits and concomitant diseases on the outcome. Adverse events will be registered.

Official Title
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Treatment of Non-severe SARS-CoV-2 Outpatients With Herbal Compound Xagrotin, Phase 3

Conditions
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Sars-cov-2

Intervention / Treatment
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* Drug: Xagrotin
* Drug: Green tea


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or higher Newly diagnosed (no longer than 10 days) PCR or clinically confirmed Covid-19 Exclusion Criteria: Coronavirus patients admitted to medical centers for hospitalization and receive medical treatment and necessary care in medical centers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Patients in the Treatment arm receive Xagrotin extract 2 grams three times a day in combination to the standard of care for sars-cov-2. | Drug: Xagrotin<br>* A herbal compound<br>|
| No Intervention: Control group<br>Patients in the Control arm received the standard of care for sars-cov-2. | |
| Placebo Comparator: Placebo group<br>Patients in the Treatment arm receive green tea 2 grams three times a day in combination to the standard of care for sars-cov-2. | Drug: Green tea<br>* Normal green tea<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Number of Participants who die by day 30 after the enrollment | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Disease From Beginning of Treatment | Number of days the patient has experienced the symptoms | 30 days | 
| Hospitalization | Number of participants who have been hospitalized for Covid-19 | 30 days | 
| Duration of Hospitalization When Occurred | Days the participants were hospitalized | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sars-cov-2