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.
ABSTRACT
COVID-19 patients have a higher risk of developing inflammatory responses associated with serious and even fatal respiratory diseases. The role of oxidative stress in exacerbating manifestations in COVID-19 pathogenesis is under-reported.This study aimed touseserum levels of superoxide dismutase (SOD3) and glutathione-S-transferase (GSTp1) by ELISA, zinc (ErbaChem5), ferritin and free iron (VitrosChemistry, Ortho Clinical Diagnosis, Raritan, NJ, USA) at the first encounter of randomly selected RT-PCR-positive COVID-19 patients, for assessing disease severity. The parameters which helped in identifying the severity, leading to poor prognosis, were neutrophil:lymphocyte higher than 4, high CRP, low SOD3 values and high GSTp1 values, and diabetes mellitus as a co-morbidity. Higher zinc levels correlated with high GSTp1 and low SOD3, indicating the protective effect of zinc on ROS. The increased high GSTp1 shows an anticipated protective biochemical response, to mitigate the low SOD3 values due to ROS consumption. Decreased SOD3 levels indicate a state of high oxidative stress at cellular levels, and an anticipated increase in GSTp1 levels points to the pathophysiological bases of increasing severity with age, sex, and co-morbidities, such asdiabetes. High levels of initial GSTp1 and zinc levels possibly offer protection to redox reactions at the cellular level in severe COVID-19 infection, preventing deterioration.
ABSTRACT
Background: Covid-19 curve can be flattened by adopting mass screening protocols with aggressive testing and isolating infected populations. The current approach largely depends on RT-PCR/rapid antigen tests that require expert personnel resulting in higher costs and reduced testing frequency. Loss of smell is reported as a major symptom of Covid-19, however, a precise olfactory testing tool to identify Covid-19 patient is still lacking. Methods: To quantitatively check for the loss of smell, we developed an odor strip, COVID-Anosmia checker, spotted with gradients of coffee and lemon grass oil. We validated its efficiency in healthy and COVID-19 positive subjects. A trial screening to identify SARS-CoV-2 infected persons was also carried out to check the sensitivity and specificity of our screening tool. Results: It was observed that COVID positive participants were hyposmic instead of being anosmic when they were subjected to smelling higher odor concentration. Our tool identified 97% of symptomatic and 94% of asymptomatic COVID-19 positive subjects after excluding most confounding factors like concurrent chronic sinusitis. Further, it was possible to reliably predict COVID-19 infection by calculating a loss of smell score with 100% specificity. We coupled this tool with a mobile application, which takes the input response from the user, and can readily categorize the user in the appropriate risk groups. Conclusion: Loss of smell can be used as a reliable marker for screening for Covid-19. Our tool can rapidly quantitate anosmia, hyposmia, parosmia, and can be used as a first-line screening tool to trace out Covid-19 infection effectively.