Treatment of Covid-19 With a Herbal Compound, Xagrotin

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 were recruited (n=361). Patients in same condition who had treated with standard of care were randomly assigned to the control group (n=178). The investigators analyzed the effect of a herbal compound, Xagrotin, and also investigated 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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This is an interventional, multi-center, randomized study that has been performed in an outpatient setting (n=361). Adults with confirmed covid-19 disease not more than 10 days before enrollment date were recruited. Patients in same condition who had treated with standard of care were randomly assigned to the control group (n=178). The investigators analyzed the effect of a herbal compound, Xagrotin, and also investigated impact of different characteristics for instance gender, age, duration of disease, smoking habits and concomitant diseases on the outcome. Adverse events were registered.

Official Title
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Treatment of Early-Stage Covid-19 With a Herbal Compound, Xagrotin

Conditions
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Covid19

Intervention / Treatment
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* Combination Product: Xagrotin


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: Severe pulmonary disease Severe cardiovascular disease Severe hepatic disease Severe renal disease Diabetes mellitus type one Metabolic acidosis Oxygen saturation <70% Pregnancy Breast feeding Concomitant treatment with anticoagulation drugs Concomitant treatment with CYP3A4 medicines with narrow therapeutic window

Ages Eligible for Study
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Minimum Age: 18 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 arm<br>Patients in the Treatment arm received Xagrotin in combination to the standard of care for Covid19. | Combination Product: Xagrotin<br>* A group of patients were treated with Xagrotin with or without standard of care, the control group received stadard of care<br>|
| No Intervention: Control arm<br>Patients in the Control arm received the standard of care for Covid19. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Number of Participants who died 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 |