mild COVID-19 patients Pharmacokinetics, Pharmacodynamics, COVID-19, Andrographis paniculata
Conditions
Interventions
single dosing of A. paniculata aqueous extract capsules (equivalent to 20 mg of andrographolide)
multiple dosing of A. paniculata aqueous extract capsules (equivalent to 60 mg/day of andrographolide)
Experimental Drug,Experimental Drug,Experimental Drug,Placebo Comparator Other
single dose 20 mg and multiple doses 60 mg/day,single dose 30 mg and multiple doses 90 mg/day,single dose 60 mg and multiple doses 180 mg/day,Placebo single and multiple doses
Sponsors
National Research Council of Thailand (NRCT)
Thailand Science Research and Innovation (TSRI)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Thai patients aged between 18 and 60 years old. 2. COVID-19 patients with mild severity, characterized by mild respiratory symptoms including cough, runny nose, sore throat, fatigue, or shortness of breath, without the presence of pneumonia and having received standard treatment. 3. Patients who have received a confirmed SARS-CoV-2 infection test within 72 hours after the onset of symptoms. 4. Willingness to participate in this research.
Exclusion criteria
Exclusion criteria: 1. Abnormal findings in chest X-ray. 2. Patients who exhibit symptoms consistent with pneumonia and have a blood oxygen saturation (SpO2) level below 95 percent. 3. Patients who have received antiviral medications, including Molnupiravir, Favipiravir, Remdesivir, Lopinavir, Ritonavir, Interferon, Chloroquine, or Hydroxychloroquine. 4. History of allergy to A. paniculata or andrographolide. 5. Pregnant or breastfeeding women, or those planning to have children. 6. Patients who have participated in other research projects for the treatment of COVID-19. 7. Patients who have administered herbal remedies or products containing A. paniculata extract or andrographolide within 5 days before the research enrollment. 8. Patients who smoke more than 10 cigarettes/day. 9. Patients with hypertension (blood pressure greater than 140/90 mmHg) who are receiving antihypertensive medication. 10. History of hepatic disease, heart disease or rheumatic heart disease or kidney disease caused by a previous Streptococcus group A infection. 11. Use of blood anti-coagulant medications (clopidogrel, warfarin, aspirin). 12. Patients at risk of experiencing severe disease progression, including: a. Chronic Obstructive Pulmonary Disease (COPD), including other chronic lung diseases such as advanced-stage tuberculosis, bacterial pneumonia, or asthma. b. Chronic Kidney Disease, acute kidney injury, or end-stage renal disease. c. Heart and blood vessel diseases, including congenital heart diseases. d. Cerebrovascular diseases. e. Uncontrolled diabetes. f. Obesity (BMI more than 35 kg/m2). g. Cirrhosis or hepatitis. h. Immunocompromised conditions, including patients with HIV infection. i. Lymphocyte count less than 1,000 cells/uL. 13. The project's medical team assesses that the patient is at risk or not suitable to participate in the research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters 0, 0.5, 0.75, 1, 1.5, 2, and 4 hours. Non compartmental analysis will be applied to determine pharmacokinetic parameters and performed by PK solutions software (version 2.0),Pharmacodynamics every 24 h (day1, 2, 3, 4 and 5) viral load,Pharmacodynamics every 24 h (day1, 2, 3, 4 and 5) CT value (RTPCR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory safety profiles day 1 (predose) and day 5 liver functions: AST and ALT; renal functions: BUN, Creatine, eGFR; lipid profiles; blood glucose and CBC | — |
Countries
Thailand
Contacts
Public ContactPhanit Songvut
Chulabhorn Research Institute
Outcome results
None listed