Efficacy and safety of Andrographis paniculata extract in patients with mild COVID-19: A randomized controlled trial

Objective: To assess the efficacy and safety of Andrographis paniculata extract (APE) in adults with mild COVID-19. Methods: The alcoholic extract of the aerial part of A. paniculata was used. In this randomized, double-blinded, placebo-controlled trial, adults with laboratory-confirmed COVID-19, and mild symptoms were randomized 1:1 to receive APE (60 mg andrographolide, t.i.d, for 5 days) versus placebo, plus standard supportive care. Blood tests for CRP, liver and renal assessment were performed on Days 1, 3, and 5. The outcomes were occurrence of pneumonia detected by chest X-ray, nasopharyngeal SARS-CoV-2 detection by rRT-PCR, changes of CRP levels, and adverse drug reactions. Results: Patients were randomized to receive APE (n=29) or placebo (n=28). Pneumonia occurrence during illness was 0/29 (0%) versus 3/28 (10.7%), (p=0.039); and patients with nasopharyngeal SARS-CoV-2 detection on Day 5 were 10/29 (34.5%) versus 16/28 (57.1%), (p=0.086), for those who received APE and placebo, respectively. All three patients with pneumonia had substantially rising serum CRP; and high CRP levels on Day 5. None had evidence of liver or renal impairment. Conclusion: This AP-extract treatment regimen was potentially effective and safe in adults with mild COVID-19. The rising of CRP suggested disease progression. Further studies are needed.