A multi-centric, open-labeled, prospective, comparative study to evaluate the efficacy and safety of Tinefcon and standard of care versus standard of care alone in patients of moderate COVID-19

COVID-19 disease features range from minor upper respiratory tract infections, mild (fever myalgia) to severe symptoms like the cytokine storm syndrome/cytokine release syndrome or even death. Patients with known corona virus infection have raised IL-6, IL-10, IL-12, IL-14, TNFα and INFg levels, 4-10 days after onset of disease (Huang C et al, 2020; Ren L et al, 2020.)

Clinical data from China showed that approximately 17.7% - 32% of patients required intensive care with evidence suggesting that cytokine release syndrome (CRS) plays a major role in the COVID-19 progression (Liu et al, 2020).

 Due to the lack of a specific treatment or vaccine against the SARS-CoV-2 infection, several agents are in clinical evaluation for the same, including agents targeting IL-6 and anti-viral agents. Recombinant monoclonal antibodies like Tocilizumab and Sarilumab and anti-viral agents like remdesivir have shown promising results in COVID-19 infection and are being evaluated further.

Sphaeranthus indicus is a freely available, weed-like plant growing across India in the hillocks and stony areas along river banks. It is also known as Gorakhmundi, Mundi or Munditika. It has been demonstrated to have immune-modulatory and anti-inflammatory properties. Extract of S. indicus fruiting and flowering heads [standardized for 7- hydroxy frullanolide (7-HF) contained not less than 5% w/w-Tinefcon] has been tested ‘in vitro’ and ‘in vivo’ for inhibitory effect on cytokine (TNF - a, IL – 1b, IL-6, IL-8, IL-12/23) release  with positive results. It has been extensively studied in animal models for efficacy; has undergone toxicity studies and clinical studies with patients of rheumatoid arthritis and psoriasis. Tinefcon has been found to show efficacy in the pre-clinical species studies and did not show any major toxicological effect in the toxicity studies conducted. There was reasonable safety and tolerability with efficacy demonstrated in the clinical studies up to a dose of 2.8 g/day of Tinefcon. Currently, it has been approved in several countries including India for marketing and is widely used.

 Given the action of Tinefcon on inhibition of LPS-induced release of TNF-α, IL-1β, IL-6 and IL-8 in human peripheral blood mono-nuclear cells (hPBMCs) in vitro and LPS-induced TNF-α release in BALB/c mice when given orally, it is anticipated to show benefits in symptomatic patients with the SARS-CoV-2 infection and halt the progression of the disease towards the cytokine release syndrome or worsening disease.

 With anticipated suppression of the acute inflammatory response in terms of cytokine release, Tinefcon will be effective in reducing the clinical signs and symptoms and should be evaluated in hospitalized, non-critically ill patients who are SARS-CoV-2 positive.