Abstract: OPEN ACCESS Freely available online Journal of Clinical Trials Research Article A Randomized, Comparative Clinical Study to Evaluate the Activity of Curvic TM Formulation for Management of SARS-COV-2 Infection (COVID-19) Yogesh Arun Dound1*, Sagar Mandlik5, Shrikant Suryavanshi2, Rajesh Sehgal3, Ajay Naik4 Department of Research & Development, Shreepad Shree Vallabh SSV Phytopharmaceuticals, C OO, Particle L ife Sciences Pvt. L td, Mumbai, 2 Maharashtra, India; Consulting Physician,Nashik, Maharashtra, India; 3 Department of Research & Development, Pharma Instinct, Noida, 5 Uttar Pradesh, India; 4 Administration, Rukmini Enterprises, Mumbai, Maharashtra, India; Chest Physician, Radiant Plus Hospital, Nashik, Maharashtra, India 1 ABSTRACT COVID-19 outbreak has put forward a huge challenge in front of researchers across the globe. Non availability of any vaccine or drug has worsened the situation and it has become a worst pandemic of modern times. Keeping scientific rationale and results of in silico studies, Researchers at Shreepad Shree Vallabh SSV Phytopharmaceuticals (SSV) have developed formulation containing natural ingredients viz Curcumin, Vitamin C, Vitamin K2-7, Selenomethionine and Zinc. Objective: To evaluate role of Curvic TM in the management of COVID-19 and its tolerability in comparison with standard treatment available from Ministry of Health and Family Welfare (MOHFW). Study design and methodology: In a randomized, two arm, comparative study, COVID-19 positive patients (n=200) were enrolled during the month of August and September 2020 from Radiant Plus Hospital, Nashik, Maharashtra, India. The enrolled patients were administered either Curvic TM 500 mg tablets twice daily or given standard treatment protocol designed by MOHFW for 10 days. The patients were evaluated for decrease in oral temperature; SpO2 and VAS score for cough and respiratory distress. The underlying mechanism was assessed by evaluating markers such as Interleukin-6, Homocysteine, D-dimer, Ferritin and C Reactive Protein. Results: In the Curvic TM group, within two days, temperature reduced considerably to afebrile level in all the subjects and remained afebrile till end of study. While in the standard treatment group, temperature reduced to afebrile stage in all the subjects by 4 days and there after remained afebrile till end of study. The elevated levels of serum Interleukin-6, Homocysteine, Di-dimer, Ferritin and C-Reactive Protein at baseline dropped considerably within normal limits within 10 days in the Curvic TM group in comparison to standard treatment group. Conclusion: Curvic TM has shown for the first time to be useful in management of COVID-19 positive patients along with improvement in the immunity, within 48 hours of starting treatment. Curvic TM was well tolerated without any side effects in any of the patients treated. Keywords: Curcumin; COVID-19; IL-6; Homocysteine; SARS-CoV