Andrographis Paniculata vs Boesenbergia Rotunda vs Control in Asymptomatic COVID-19

Study Overview
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Brief Summary
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The purpose of this study is to examine the effect of Andrographis Extract, Boesenbergia Extract compared to standard treatment in asymptomatic COVID patients.

Official Title
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A Two-stage Adaptive Randomized Controlled Trial of Andrographis Paniculata Extract, Boesenbergia Rotunda Extract, and Standard Treatment in Asymptomatic COVID-19 Patients

Conditions
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Covid19

Intervention / Treatment
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* Drug: Andrographis Paniculata
* Drug: Boesenbergia
* Other: Standard supportive treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18- 60 years old Have been diagnosed as new COVID-19 case by RT-PCR since disease onset to admission less than 7 days Have asymptomatic infection assessed by the World Health Organization (WHO) disease category Do not have any of following disease or conditions Body weight > 90 kg or BMI > 30 kg/m2 Hypertension that needs antihypertensive medication Diabetes Cardiovascular diseases including congenital heart disease Cerebrovascular diseases Chronic kidney and chronic liver diseases COPD or chronic lung diseases Lymphocyte <1,000 cells/mm3 Late-stage cancer Auto-immune disease (e.g., SLE, Rheumatoid arthritis, multiple sclerosis, etc.) or currently on immunosuppressive drug Coagulation disorders or platelet disorders and are being treated with anticoagulants such as warfarin, clopidogrel Pregnancy Willing to participate with the study and sign inform consents. (Withdrawal criteria) Patients withdraw from the study Have severe adverse effect that may relate to Andographolide or Boesenbergia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Andrographis extract<br>Andrographis extract, equivalent to andrographolide 20 mg per capsule, for a total of 180 mg of andrographolide per day, dosing into 3 capsules taking before meal for 3 times per day, for 5 days. | Drug: Andrographis Paniculata<br>* Andrographis extract, equivalent to andrographolide 20 mg per capsule, for a total of 180 mg of andrographolide per day, dosing into 3 capsules taking before meal for 3 times per day, for 5 days.<br>|
| Experimental: Boesenbergia extract<br>Boesenbergia extract, equivalent to pinostrobin 30 mg per capsule, for a total of 180 mg of pinostrobin per day, dosing into 2 capsules taking after meal for 3 times per day for 5 days. | Drug: Boesenbergia<br>* Boesenbergia extract, equivalent to pinostrobin 30 mg per capsule, for a total of 180 mg of pinostrobin per day, dosing into 2 capsules taking after meal for 3 times per day for 5 days.<br>|
| Other: Standard supportive treatment<br>Standard supportive treatment, as recommended by guideline from Ministry of Public Health, Thailand, there will be no antivirus given in this asymptomatic group | Other: Standard supportive treatment<br>* as recommended by guidelines from the Ministry of Public Health, Thailand. No antivirus was given.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Require hospitalization in the hospital | From WHO clinical progression scale (0-10): 0: Uninfected with no viral RNA detected Asymptomatic with viral RNA detected Symptomatic and independent Symptomatic with assistance needed Hospitalized with no oxygen therapy needed Hospitalized with oxygen mask or nasal prongs Hospitalized with oxygen by NIV or high flow Intubation and mechanical ventilation with pO2/FiO2 >= 150 or SpO2/FiO2 >= 200 Mechanical ventilation with pO2/FiO2 < 150 (SpO2/FiO2 <200) or vasopressor Mechanical ventilation with pO2/FiO2 < 150 and vasopressor, dialysis, or ECMO Dead Outcome 4 or more considered as hospitalization | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual status from WHO clinical progression scale (0-10) | From WHO clinical progression scale: 0: Uninfected with no viral RNA detected Asymptomatic with viral RNA detected Symptomatic and independent Symptomatic with assistance needed Hospitalized with no oxygen therapy needed Hospitalized with oxygen mask or nasal prongs Hospitalized with oxygen by NIV or high flow Intubation and mechanical ventilation with pO2/FiO2 >= 150 or SpO2/FiO2 >= 200 Mechanical ventilation with pO2/FiO2 < 150 (SpO2/FiO2 <200) or vasopressor Mechanical ventilation with pO2/FiO2 < 150 and vasopressor, dialysis, or ECMO Dead More on the scale - worse outcome | 28 days | 
| Pneumonia | Pneumonia by diagnosis or chest radiography | 28 days | 
| Quality of life by EQ5D-5L | Quality of life by EQ5D-5L Scale of 0 to 100 for overall health state (lower is worse) and 1 to 5 in each of 5 domains. (higher score is worse) | 28 days | 
| Side effect of medication | Renal and liver function elevation and other anticipated/unanticipated side effect: Side effect of medication will be classified according to common terminology criteria for adverse events (CTCAE) version 5.0 | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Covid19, Treatment, Andrographis, Boesenbergia