DOI: 10.6084/m9.figshare.19761541
title: 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

description: <strong>Objective</strong>: Coronavirus, hence named because of the crown-like spikes on the viral envelope, is a member of Coronaviridae family and Order Nidovirales. SARS-CoV-2 is the seventh 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 virulence 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. 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. <strong>Methods</strong>: A total of 123 eligible subjects as per inclusion criteria were randomized within the study. However, three subjects 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 recruited and 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 for RT-PCR negative was evaluated after treatment with ZingiVir-H or Placebo for a minimum of ten days. The liver and kidney function tests were regularly assessed to ensure the safety profile of ZingiVir-H. <strong>Results</strong>: 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 all the patients treated with ZingiVir-H demonstrated significant distribution in clinical status from ordinal scale 5 to 6 and 7 within five to seven days when compared to that of placebo. Upon analysis of the clinical trial data, it was clear that 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 undesirable effects on liver and kidney function affirmed the safety profile of ZingiVir-H. Moreover, no serious adverse events were reported in ZingiVir-H treated patients. <strong>Conclusion</strong>: Compiling the results, we found that ZingiVir-H is very 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 yet.