A randomised Phase-I safety and tolerability study of two dosing regimens of Quercetin bar inhealthy healthcare workers in a tertiary care hospital

Quercetin is naturally occurring flavonoid found in various fruits, vegetables, tea, coffee and other beverages. It is a very good antioxidant, anti-inflammatory and immunomodulatory agent. It is an ideal molecule because its potential use against severe chronic diseases like ashthma, ARDS, arthritis, diabetis, cardiovascular problems, cancer and  anti-viral etc as been confirmed by systematic research. Quercetin targets several molecular pathways like NFkB, Hif-1alpha, NO, B2AR, PDE pathways and modulate different proteins like lung surfactants, tight junction proteins and maintains several physiological parameters in more or less similar to normal ranges without any toxicity andresistance. Based on the available literature it is expected to have prophylactic and therapeutic efficacy against COVID-19. Therefore, it is proposed that quercetin can be used for prevention of Covid-19 (SARS-CoV 2) infection in healthcare workers who are at risk of exposure and as an adjunct therapy for confirmed mild to moderate and severe of Covid-19.

The present study (Phase-I) is being conducted as a randomized study to assess the safety and tolerability of Quercetin at two dose regimens in Indian population/ health care workers. Quercetin will be supplied as individually packed nutracuetical bar (containing 500 mg of quercetin). Twenty healthy male and female volunteers will be enrolled and randomized in to 2 groups of 10 each. Group 1 will receive one Quercetin bar in the morning, whereas, Group 2 will receive 2 Quercetin bars (morning one and evening one) for 14 days. The subjects will have their scheduled Follow-up visits for recording of study parameters and clinical tests for a total period of 28 days (including 1 week extended follow up after 21 days). Health parameters including physiological and biochemical test will be conducted at 0 day, 14th day and on 21st day.