A daily intake of a new dietary supplement (Nasafytol) containing an oral combination of Quercetin (65 mg), Curcumin (42 mg) and Vitamin D3 (2.2 µg) for 14 days by early-stage mild to moderately symptomatic COVID-19 outpatients, resulted in more rapid clearance of the SARS-CoV-2 viral infection, more rapid resolution of COVID-19 associated acute symptoms and more rapid improvement in the inflammatory marker CRP levels; leading to speedier recovery of the patients.
BRUSSELS, Oct. 5, 2022 /PRNewswire/ -- The study which was recently published in the leading journal in its field, Frontiers in Pharmacology, was a randomized controlled clinical trial conducted at the Department of Medicine, King Edward Medical University, Lahore, PK under the supervision of Dr. Amjad Khan, DPhil, M.Sc (Oxford), a Co-lead investigator of the study, and a Visiting Academic Researcher at the INEOS Oxford Institute for Antimicrobial Research, and Nuffield Division of Clinical and Laboratory Sciences, Radcliffe Department of Medicine, University of Oxford, UK. The clinical trial compared the treatment effect of Nasafytol as add-on to the standard of care (SOC) vs SOC alone (control group) in the early-stage mild to moderately symptomatic RT-PCR confirmed COVID-19 outpatients. The standard of care included paracetamol and/or antibiotic azithromycin. Patients in the Nasafytol group received two capsules twice a day for 14 days. Patients in both groups received the same SOC.
A total of 50 randomized patients (25 in each treatment group) completed the study. Patients who received the Nasafytol adjuvant therapy showed expedited negativization of the nasopharyngeal swab SARS-CoV-2 RT-PCR test at day 7, i.e; 15 (60.0%) vs 5 (20.0%) of the control group, p = 0.009. COVID-19 associated acute symptoms were more rapidly resolved in the Nasafytol group at day 7, i.e; 15 (60.0%) vs 10 (40.0%) of the control group. Patients in the Nasafytol group showed a significant greater fall in the serum CRP levels at day 7, i.e; from medium34.0 to 11 mg/dL as compared to the control group, i.e; from 36.0 to 22.0 mg/dL, p = 0.006. The Nasafytol adjuvant therapy was safe and well-tolerated by all 25 patients and no treatment emergent effects, complications, side-effects, or serious adverse events were reported.
Quercetin, and Curcumin, the two extensively studied natural polyphenols, reportedly possess broad-spectrum anti-viral, anti-inflammatory, immunomodulatory, and antioxidant pharmacological effects, and vitamin D3 is also a well-known immunomodulatory agent. The inhibition of the SARS-CoV-2 viral replication and simultaneously modulation of the host hyper-inflammatory response in the early stage of COVID-19 infection is considered as crucial for the speedy recovery and prevention of progression to severe illness. Quercetin and Curcumin have previously shown inhibition of coronaviruses in in vitro assays, and more recently have shown inhibitory activities against SARS-COV-2. "The combination of Quercetin, Curcumin, and Vitamin D3 is a scientifically-backed safe adjuvant to treat COVID-19 in the early-stage; and the results shown by Nasafytol are very encouraging and likely due to effective synergistic immunomodulatory, antioxidant, anti-inflammatory and antiviral mechanisms of Quercetin, Curcumin and Vitamin D3", said Dr. Amjad Khan.
The use of immunomodulatory/anti-inflammatory therapies in clinically vulnerable COVID-19 patients such as those with underlying health conditions or immunocompromised patients, may also cause immune-suppression, which can increase the risk of development of secondary bacterial or fungal infection and hence progression to severe illness. On the contrary, Quercetin, Curcumin and Vitamin D3 naturally have no immune-suppression effect. Quercetin, and Curcumin are safe agents and have received the FDA GRASS (Generally Recognised As Safe) status for human use in dietary products. In combination with routine care, the adjuvant use of Nasafytol may help in the speedier recovery of early-stage mild-to-moderately symptomatic COVID-19 infection, facilitated by early clearance of the SARS-CoV-2 viral infection and modulation of the immune response.
The study full article is available online at: doi: 10.3389/fphar.2022.898062
Trial clinicaltrials.gov identification number: NCT05130671.
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