A prospective, open label, randomized-controlled study to evaluate the efficacy and safety of MyVir tablets in mildly symptomatic COVID-19 patients
DOI:
https://doi.org/10.18203/2319-2003.ijbcp20212926Keywords:
COVID-19, Complications, Antiviral, Immune booster, MyVirAbstract
Background: Coronavirus can cause pneumonia, respiratory failure and death. The emergence of novel coronavirus has posed a challenging situation that warrants urgent global attention. Currently there was no effective therapy available for COVID-19 and hence antiviral and immune modulators are most sought after medicines to manage complications of COVID-19.
Methods: In this study involving mild COVID-19 we randomized 42 patients to receive a MyVir tablets twice daily along with standard of care (SOC) or SOC alone in 1:1 ratio for 14 days. We evaluated the benefits of MyVir tablets by assessing clinical outcomes and improvement in immune markers (LDH, CRP, D-dimer, TLC).
Results: At the end of the study the immune markers in MyVir group improved significantly compared to control group. In patients who received MyVir, CRP decreased from 3.3 mg/l to 1.7 mg/l (p=0.0171). D-dimer decreased from 0.589 on day 0 to 0.368 on day 14 (p=0.03) and LDH decreased from 224 U/l on day 0 to 158 U/l on day 14 in test group (p=0.05). TLC showed favorable improvement in study group compared to control group. Early recovery from COVID-19 symptoms was observed in patients on MyVir treated group. Patients treated with MyVir tablets reduced the duration of hospitalization when given along with standard of care.
Conclusions: MyVir accelerated recovery of COVID-19 patients by early improvement in clinical symptoms and immune markers in this study and results clearly indicates that MyVir tablets has antiviral, immune booster activity. Hence this study provides evidence that MyVir has definitive role in the management of mild COVID-19 patients along with standard of care (funded by Mi Lab Life Sciences(P) Ltd. CTRI no. CTRI/2020/05/024967).
Metrics
References
WHO. Fact sheet: WHO Coronavirus (COVID-19) Dashboard Overview, 2021. Available at: https://covid19.who.int/. Accessed on 23 May 2021.
WHO. Fact sheet: Global India, 2021. Available at: https://covid19.who.int/region/searo/country/in. Accessed on 23 May 2021.
Tang N, Li D, Wang X, Sun Z. Abnormal coagulation parameters are associated with poor prognosis in patients with novel coronavirus pneumonia. J Thromb Haemost. 2020;18(4):844-7.
Levi M, Poll T. Coagulation and sepsis. Thromb Res. 2017;149:38-44.
Churiyah Pongturulan OB, Roofani E, Tarwadi. Antiviral and immunostimulant activities of Andrographis paniculata. Hayati J Biosci. 2015;22(2):67-72.
Chowdhury P. In silico investigation of phytoconstituents from Indian medicinal herb Tinospora cordifolia (giloy) against SARS-CoV-2 (COVID-19) by molecular dynamics approach. J Biomol Struct Dyn. 2020:1-18.
Moghadamtousi SZ, Kadir HA, Hassandarvish P, Tajik H, Abubakar S, Zandi K. A Review on Antibacterial, Antiviral, and Antifungal Activity of Curcumin. Biomed Res Int. 2014;2014:186864.
Alzohairy MA. Therapeutics role of Azadirachta indica (neem) and their active constituents in diseases prevention and treatment. Evid Based Complement Alternat Med. 2016;2016:7382506.
Cohen MM. Tulsi-Ocimum sanctum: a herb for all reasons. J Ayurveda Integr Med. 2014;5(4):251-9.
Kaushik S, Jangra G, Kundu V, Yadav JP, Kaushik S. Anti-viral activity of Zingiber officinale (ginger) ingredients against the chikungunya virus. Virusdisease. 2020;31(3):270-6.
Kamala A, Middha SK, Karigar CS. Plants in traditional medicine with special reference to Cyperus rotundus L.: a review. 3 Biotech. 2018;8(7):309.
Rouf R, Uddin SJ, Sarker DK, Islam MT, Ali ES, Shilpi JA, et al. Antiviral potential of garlic (Allium sativum) and its organosulfur compounds: a systematic update of pre-clinical and clinical data. Trends Food Sci Technol. 2020;104:219-34.
Weber ND, Andersen DO, North JA, Murray BK, Lawson LD, Hughes BG. In vitro virucidal effects of Allium sativum (garlic) extract and compounds. Planta Med. 1992;58(5):417-23.
Senthilvel P, Lavanya P, Kumar KM, Swetha R, Anitha P, Bag S, et al. Flavonoid from Carica papaya inhibits NS2B-NS3 protease and prevents Dengue 2 viral assembly. Bioinformation. 2013;9(18):889-95.
Sharma N, Mishra KP, Chanda S, Bhardwaj V, Tanwar H, Ganju L, et al. Evaluation of anti-dengue activity of Carica papaya aqueous leaf extract and its role in platelet augmentation. Arch Virol. 2019;164(4):1095-110.
Xiao AT, Tong YX, Gao C, Zhu L, Zhang YJ, Zhang S. Dynamic profile of RT-PCR findings from 301 COVID-19 patients in Wuhan, China: a descriptive study. J Clin Virol. 2020;127:104346.
Chai X, Hu L, Zhang Y, Han W, Lu Z, Ke A, et al. Specific ACE2 expression in cholangiocytes may cause liver damage after 2019-nCoV infection. BioRxiv. 2020.
Pan L, Mu M, Yang P, Sun Y, Wang R, Yan J, et al. Clinical characteristics of COVID-19 patients with digestive symptoms in Hubei, China: a descriptive, cross-sectional, multicenter study. Am J Gastroenterol. 2020;115(5):766-73.
Henry BM, Oliveira MHSD, Benoit S, Plebani M Lippi G. Hematologic, biochemical and immune biomarker abnormalities associated with severe illness and mortality in coronavirus disease 2019 (COVID-19): a meta-analysis. Clinic Chem Lab Med (CCLM). 2020;58(7).
Shi J, Li Y, Zhou X, Zhang Q, Ye X, Wu Z, et al. Lactate dehydrogenase and susceptibility to deterioration of mild COVID-19 patients: a multicenter nested case-control study. BMC Med. 2020;18:168.
Tan W, Zhao X, Ma X, Wang W, Niu P, Xu W, et al. A novel coronavirus genome identified in a cluster of pneumonia cases-Wuhan, China 2019-2020. China CDC Weekly. 2020;2(4):61-2.
Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020;395(10223):497-506.
Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, et al. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020;395(10223):507-513.
Qin C, Zhou L, Hu Z, Zhang S, Yang S, Tao Y, et al. Dysregulation of immune response in patients with coronavirus 2019 (COVID-19) in Wuhan, China. Clin Infect Dis. 2020;71(15):762-8.
Khan S, Ali A, Shie H, Siddique R, Shabana, Nabif G, et al. COVID-19: clinical aspects and therapeutics responses. Saudi Pharmaceut J. 2020;28(8):1004-8.
Ge H, Wang X, Yuan X, Xiao G, Wang C, Deng T, et al. The epidemiology and clinical information about COVID-19. Eur J Clin Microbiol Infect Dis. 2020:1-9.
Lippi G, Mattiuzzi C, Bovo C, Plebani M. Current laboratory diagnostics of coronavirus disease 2019 (COVID-19). Acta Biomed. 2020;91(2):137-45.
Mishra Y, Pathak BK, Mohakuda SS, Sen S, Singh R, Singh AR. Relation of D-dimer levels of COVID-19 patients with diabetes mellitus. Diabetes Metab Syndr. 2020;14(6):1927-30.
Rostami M, Mansouritorghabeh H. D-dimer level in COVID-19 infection: a systematic review. Expert Rev Hematol. 2020:1-11.
Vidali S, Morosetti D, Cossu E, Luisi MLE, Pancani S, Semeraro V, et al. D-dimer as an indicator of prognosis in SARS-CoV-2 infection: a systematic review. ERJ Open Res. 2020;6(2):00260-2020.
Yu H, Qin C, Chen M, Wang W, Tian D. D-dimer level is associated with the severity of COVID-19. Thromb Res. 2020;195:219-25.
Heneka MT, Golenbock D, Latz E, Morgan D, Brown R. Immediate and long-term consequences of COVID-19 infections for the development of neurological disease. Alzheimers Res Ther. 2020;12(1):69.
Dasgupta A, Kalhan A, Kalra S. Long term complications and rehabilitation of COVID-19 patients. J Pak Med Assoc. 2020;70(5):131-5.
Jiang DH, McCoy RG. Planning for the post-COVID syndrome: how payers can mitigate long-term complications of the pandemic. J Gen Intern Med. 2020;35(10):3036-9.
Lee JK, Kwak BO, Choi JH, Choi EH, Kim JH, Kim DH. Financial burden of hospitalization of children with coronavirus disease 2019 under the national health insurance service in Korea. J Korean Med Sci. 2020;35(24):224.