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

Phase 2

Completed

• Conditions: Mild to moderate COVID-19; andrographolides, COVID-19, SARS-CoV-2, andrographis panniculata, favipiravir

• Registration Number: TCTR20210609001
• Lead Sponsor: Chulabhorn Royal Academy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-09
• Study Completion: 2021-09-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 146

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified