Prospective study of Andrographolide and Favipiravir versus Favipiravir Monotherapy to prevent severe pulmonary involvement in patients with COVID-19

Phase 2

• Conditions: Mild to moderate severity of COVID-19 infection.; Andrographolide; Andrographis paniculate; Favipiravir; Coronavirus-2019; SARS-CoV-2

• Registration Number: TCTR20210906002
• Lead Sponsor: Ratchadapisek Somphot Fund, Chulalongkorn University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-06
• Study Completion: 2022-02-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. SARS-CoV-2 RT-PCR positive
2. Mild severity of COVID-19 infection
3. Moderate severity of COVID-19 infection

Exclusion Criteria

1. Required High flow nasal cannula (HFNC) support
2. Required NIV FiO2 >0.6
3. Allergu to Andrographolide or Favipiravir
4. AST or ALT > 5ULN at baseline
5. ESRD, cirrhosis, Chronic lung disease, COPD

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients developing Severe pneumonia 6 months Number of patients developing severe pneumonia defined as required High flow nasal cannula (HFNC) support or required NIV

Secondary Outcome Measures

Name	Time	Method
Compare proinflammatory cytokine 6 months Laboratory test for proinflammatory cytokine such as CRP, IL-6 at day 7, 14 ,Hepatotoxicity and other adverse events 6 months Laboratory test for liver function test at day 7, 14