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

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

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

Study Overview

• Status: Recruiting
• Conditions: Covid19
• Intervention / Treatment: Drug: Andrographis Paniculata; Drug: Boesenbergia; Other: Standard supportive treatment

• Study Type: Interventional
• Enrollment (Anticipated): 3060
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Pawin Numthavaj; Phone Number: +6622011284; Email: pawin.num@mahidol.ac.th

Study Locations

• Thailand
  • Bangkok
    • Ratchathewi, Bangkok, Thailand, 10400
      • Recruiting
      • Faculty of Medicine Ramathibodi Hospital
      • Contact: Pawin Numthavaj, MD; Phone Number: +6622011284; Email: pawin.num@mahidol.ac.th

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 18- 60 years old
2. Have been diagnosed as new COVID-19 case by RT-PCR since disease onset to admission less than 7 days
3. Have asymptomatic infection assessed by the World Health Organization (WHO) disease category

4. Do not have any of following disease or conditions

   1. Body weight > 90 kg or BMI > 30 kg/m2
   2. Hypertension that needs antihypertensive medication
   3. Diabetes
   4. Cardiovascular diseases including congenital heart disease
   5. Cerebrovascular diseases
   6. Chronic kidney and chronic liver diseases
   7. COPD or chronic lung diseases
   8. Lymphocyte <1,000 cells/mm3
   9. Late-stage cancer
   10. Auto-immune disease (e.g., SLE, Rheumatoid arthritis, multiple sclerosis, etc.) or currently on immunosuppressive drug
   11. Coagulation disorders or platelet disorders and are being treated with anticoagulants such as warfarin, clopidogrel
   12. Pregnancy
5. Willing to participate with the study and sign inform consents.

(Withdrawal criteria)

1. Patients withdraw from the study
2. Have severe adverse effect that may relate to Andographolide or Boesenbergia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Andrographis extract; 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; 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.
Experimental: Boesenbergia extract; 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; 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.
Other: Standard supportive treatment; 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; as recommended by guidelines from the Ministry of Public Health, Thailand. No antivirus was given.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mahidol University
• Collaborators: Ministry of Health, Thailand

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2021
• Primary Completion (Anticipated): May 30, 2022
• Study Completion (Anticipated): May 30, 2022

Study Registration Dates

• First Submitted: August 21, 2021
• First Submitted That Met QC Criteria: August 21, 2021
• First Posted (Actual): August 24, 2021

Study Record Updates

• Last Update Posted (Actual): September 9, 2021
• Last Update Submitted That Met QC Criteria: September 1, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Treatment; Covid19; Andrographis; Boesenbergia
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Anti-Infective Agents; Peripheral Nervous System Agents; Antiviral Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Platelet Aggregation Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Andrographolide
• Other Study ID Numbers: MURA2021/652

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: May shared IPD upon sponsor decision.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No