An efficacy and safety report based on randomized controlled single-blinded multi-centre clinical trial of ZingiVir-H, a novel herbo-mineral formulation designed as an add-on therapy in adult patients with mild to moderate COVID-19

Abstract

Objective Coronaviruses, hence named because of the crown-like spikes on the viral envelope, are members of Coronaviridae family and Order Nidovirales. SARS-CoV-2 is the seventh human pathogenic coronavirus identified after HCoV-229E, HCoV-OC43, SARS-CoV (SARS-CoV-1), HCoV-NL63, CoV-HKU1, and MERS-CoV. SARS-Cov-2 is highly similar to SARS-CoV. COVID-19 is the corresponding acute disease caused by SARS-CoV-2 that was initially reported in Wuhan, China towards the end of 2019 and spread to millions of humans globally. Unfortunately, limited studies were available on the efficacy of antiviral drugs to treat COVID-19 at the time of this study. ZingiVir-H is an Ayurvedic formulation for use in early therapy of viral disease. This clinical trial was planned to investigate (1) the efficacy and safety of ZingiVir-H and (2) the efficacy of ZingiVir-H as an add-on therapy to the standard of care in hospitalized adults diagnosed with COVID-19. Methods A total of 123 eligible subjects as per inclusion criteria were randomized within the study. Three subjects later declined to participate in the study and four subjects didn’t meet inclusion criteria, which brought the final evaluable subject count to 116 for the efficacy and safety endpoint analysis. Thus, a total of 116 patients were equally randomised into two groups, namely, ZingiVir-H and Placebo for this clinical trial. The study patients were assigned to receive either ZingiVir-H or Placebo along with the standard of care as per the National Indian COVID-19 treatment protocol. The time interval until a negative RT-PCR obtained, was evaluated during treatment with ZingiVir-H or Placebo for ten days. Liver and kidney function tests were regularly assessed to ensure the safety profile of ZingiVir-H. Results The study found that patients who were administered ZingiVir-H had a median recovery time of 5 days (95% confidence interval (CI) 5–5) when compared to 6 days (95% CI 5–6) in those who received Placebo. Besides, in Ordinal Scale analysis of all the patients treated with ZingiVir-H demonstrated significant redistribution to a better clinical status from ordinal scale 5 to 6 and 7 within five to seven days when compared to that of placebo treatment. The time required for clinical improvement and the number of days needed for hospitalization was significantly less in the ZingiVir-H treated group when compared to placebo. The absence of liver and kidney function changes affirmed the safety profile of ZingiVir-H. No serious adverse events were reported in ZingiVir-H treated patients. Conclusion We found that ZingiVir-H is effective and safe in managing COVID-19 infections and delaying the disease progression from mild to moderate and moderate to severe. To the best of our knowledge, this is the first clinical trial report on the efficacy/safety of a herbo-mineral Ayurvedic drug against COVID-19 as of yet. Trial registration Clinical Trial Registry of India CTRI/2020/04/024883. Registered on 28/04/2020.