Mild to moderate COVID-19 andrographolides, COVID-19, SARS-CoV-2, andrographis panniculata, favipiravir
Conditions
Interventions
Andrographolides capsule with active ingredient (AP1 more than 20 mg/ capsule) is administered 180 mg per day for 5 days combined with the standard treatment favipiravir is 3600 mg on the first day a
Active Comparator Drug,Placebo Comparator Drug
Andrographolides combined with Favipiravir ,A placebo combined with Favipiravir
Sponsors
Chulabhorn Royal Academy
Eligibility
Sex/Gender
All
Age
20 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age equal or more than 20 years 2. Symptomatic equal or less than 4 days after onset of a symptom: At least one of the following symptom; fever, cough, runny nose, sore throat, dyspnea, chest discomfort, diarrhea, anosmia, ageusia 3. Absence of pneumonia from chest X-ray or presence of 1-2 focal infiltration confined in unilateral of lung or overall CT severity score < 7 (mild pneumonia) 4. WHO clinical progression scale < 2, CURB65<2 5.CRP<15 mg/L 6. Thai language communicable 7. Accept to follow up according to protocol 8. SARS-CoV-2 PCR from Nasopharyngeal specimen is positive at least 2 gene and initial Ct value less than 35 9. Accept the informed consent
Exclusion criteria
Exclusion criteria: 1. Pregnancy or breastfeeding 2. Severe illness: including pneumonia with the following condition 2.1 Respiratory rate more than 24 per minute 2.2 Oxygen saturation less than 96% 2.3 Need for oxygen therapy 2.4 Respiratory failure, multiorgan failure, shock 2.5 Chest X-ray showed bilateral infiltration or more than 3 focal infiltrations in unilateral lung or chest CT showed multifocal consolidation, crazy paving pattern, or overall CT severity score > 7 3. Intake anti-SARS-CoV-2 therapy 4. History of andrographolide allergy 5. Recieve drug or herb which have andrographolide extract in the composition 6. severe nausea, vomiting, diarrhea, bleeding tendency, and other severe symptoms 7. Evidence of bacteria infection including Streptococcal pharyngitis, high graded fever with chill 8. History of rheumatic heart disease or post-streptococcal glomerulonephritis 9. Chronic kidney disease (CKD) or chronic liver disease 10.On clopidogrel, warfarin, aspirin more than 81 mg/ day 11. Received antibiotic, anti-inflammatory agent, steroid, NSAIDS, Herb within 48 hours after symptom onset 12.Received immunosuppressive drugs or chemotherapy 13. Complete coronavirus vaccination more than 2 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical stable or improvement of symptom 4th day visual analog scale score stable or improve | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical improvement 5th day visual analog scale score improve at least 15% more than placebo,Clinical improvement 14th day visual analog scale score improve at least 35% more than placebo,Duration from start treatment until symptom improvement within 14 day Day of improvement,Clinical stable or improvement 5th day SpO2 more than 95% or stable of pneumonia or WHO clinical progression scale equal or less than 3 or COVID-19 severity index equal or less than 8 , no deterioration of at least 2 symptoms,Compare clinical deterioration in pnuemonia and mild illness day 5, 14 Clinical improve, stable, deterioration,Rate of oxygen therapy, mechanical ventilation, ICU admission, survival rate at any time Number of patients with oxygen therapy, mechanical ventilation, ICU admission, survival,Biomarker level in andrographolides group compared with placebo group change in D5, D14 Mean, statistical difference,Resolotion or progression of radioimaging D5, D14 changingin CT severity score or improvement or resolution ,Cytokines change D5, 14 compared cytokines level in andrographolides and plcebo,Virologic response D5, D14 Change in Ct value, viral load and viral culture,Immunologic response to infection D5, D14, D28 nucleocapsid antibody, RBD spike antibody, neutralizing antibody,Advere events or side effect D5, D14 Number and grade of adverse events | — |
Countries
Thailand
Contacts
Public ContactTaweegrit Siripongboonsitti
Chulabhorn Hospital, HRH Princess Chulabhorn College of Medical Science, Chulabhorn Royal Academy
Outcome results
None listed