TCTR20210609001CompletedPhase 2
Efficacy of Andrographis paniculata extract Combined with Favipiravir Treatment to Prevent Disease Progression in mild to moderate COVID-19 Patients: A Double-blind, Randomized, Placebo-Controlled Study
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Chulabhorn Royal Academy
- Enrollment
- 146
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 20 Years to N/A (No limit) (—)
- Sex
- All
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
- •1. Pregnancy or breastfeeding
- •2. Severe illness: including pneumonia with the following condition
- •2.1Respiratory rate more than 24 per minute
- •2.2Oxygen saturation less than 96%
- •2.3Need for oxygen therapy
- •2.4Respiratory failure, multiorgan failure, shock
- •2.5Chest 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
Investigators
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