Volume : 09, Issue : 05, May – 2022

Title:

57.OVERVIEW OF CLINICAL RESEARCH AND ITS APPLICATIONS IN DRUG DISCOVERY AND MANAGEMENT OF COVID-19 IN INDIA

Authors :

Ganesh Pawar*, Sanket More, Krupesh Patil, Sunanda Malode

Abstract :

COVID-19 is a disease caused by SARS-CoV-2 that can trigger what scientists call a respiratory tract infection. It can affect your upper respiratory tract (sinuses, nose, and throat) or lower respiratory tract ( lungs and windpipe). The clinical demonstration of SARS-CoV-2-infected patients ranged from mild non-specific symptoms to severe pneumonia with organ function destruction. In December 2019, adults in Wuhan, capital city of Hubei province and a major transportation hub of China started presenting to local hospitals with severe pneumonia of unknown cause. Research on COVID-19 from Alternative and Complementary Medicines are being carried out in many countries. In Ayurveda, the majority of the trials are related to ayurvedic drugs or drug combinations. The recommended formulations, some have undergone scientific investigations, such as AYUSH, Arsenica Album, Chyawanprash, Kabasur Kudineer, Guduchi, Ghanavati, Nilavembu Kudineer, for their possible preventive or therapeutic impact. One of the potential treatment strategies is the discovery of drugs by targeting essential proteins in viral life cycle. Main Protease become an attractive drug target, since it plays a pivotal role in mediating viral transcription and replication. According to the data published by FDA’s Coronavirus Treatment Acceleration Program (CTAP), as on 31 December 2020 there were 595+ drug development programs in planning stages, 400+ trials reviewed by FDA, 8 treatments currently authorised for emergency use and 1 treatment approved for COVID 19.
KEYWORDS: COVID-19, SARS-CoV-2, Clinical research, AYUSH, Drug discovery process

Cite This Article:

Please cite this article in press Ganesh Pawar et al, Overview Of Clinical Research And Its Applications In Drug Discovery And Management Of Covid-19 In India., Indo Am. J. P. Sci, 2022; 09(5).,

Number of Downloads : 10

References:

1. Wang Chen, Horby Peter W, Hayden Frederick G, Gao George F. A novel coronavirus outbreak of global health concern. The Lancet. 2020;395(10223):470–473.
2. Coronavirus Outbreak. Available at: https://www.worldometers.info/coronavirus/. Accessed 23 Feb 2020.
3. Wu, Yi-Chi, Ching-Sung, Chan, Yu-Jiun. The outbreak of COVID-19: An overview. Journal of the Chinese Medical Association: 2020 March; 83(3): 217-220.
4. Singhal Tanu. A Review of Coronavirus Disease-2019 (COVID-19) Indian J Pediatr.2020: 87(4): 281-286.
5. World Health Organization. GCM teleconference-Note for the Records. 10 January 2020. Subject: Pneumonia in Wuhan, China. Available from: https: www.who.int/blueprint/10-01-2020-nfr-gcm.pdf?ua=1
6. World health Organization. Teleconference of the R&D Blueprint GCM. 20 January 2020. Pneumonia of unknown etiology in Wuhan China. Available from: https://www.who.int/blueprint/priority-diseases/key-action/20-01-2020-nfr-gcm.pdf?ua=1
7. Chaplin S. Covid-19: a brief history and treatments in development. Wiley 2020 May; 31(5): 23-28.
8. Andrews, MA. Areekal, Binu Rajesh, KR Krishnan, Jijith Suryakala, R Krishnan, Biju Murali, CP Santosh, PV (May 2020). First confirmed case of COVID-19 infection in India: A case report. Indian J of Medical Research. 2021 June; 151(5): 490-92.
9. Narasimhan, T. E. (30 January 2020). “India’s first coronavirus case: Kerala student in Wuhan tested positive”. Business Standard India. Archived from the original on 11 March 2020. Retrieved 7 March 2020.
10. “India’s first coronavirus patient discharged after being cured”. Hindustan Times. 20 February 2020. Retrieved 24 July 2021.
11. Xinhua. China’s CDC detects a large number of new coronaviruses in the South China seafood market in Wuhan. Available at: https:// www.xinhuanet.com/2020-01/27/c_1125504355.htm. Accessed 20 Feb 2020.
12. Huang C, Wang Y, Li X, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020;395: 497–506.
13. Rothe C, Schunk M, Sothmann P, et al. Transmission of 2019- nCoV infection from an asymptomatic contact in Germany. N Engl J Med. 2020. https://doi.org/10.1056/NEJMc2001468.
14. Li Q, Guan X, Wu P, et al. Early transmission dynamics in Wuhan, China, of novel coronavirus-infected pneumonia. N Engl J Med. 2020. https://doi.org/10.1056/NEJMoa2001316.
15. World Health Organization. Situation reports. Available at: https:// www.who.int/emergencies/diseases/novel-coronavirus-2019/ situation-reports/. Accessed 22 Feb 2020.
16. Cheng ZJ, Shan J. 2019 novel coronavirus: where we are and what we know. Infection. 2020:1–9. https://doi.org/10.1007/s15010-020- 01401-y.
17. Coronavirus Outbreak. Available at: https://www.worldometers. info/coronavirus/. Accessed 23 Feb 2020.
18. Q. Li, X. Guan, P. Wu, X. Wang, L. Zhou, Y. Tong, et al., Early transmission dynamics in Wuhan, China, of novel coronavirus-infected pneumonia, N. Engl. J. Med. (2020).
19. W. Wang, J. Tang, F. Wei, Updated understanding of the outbreak of 2019 novel coronavirus (2019-nCoV) in Wuhan, China, J. Med. Virol. 92 (4) (2020) 441–447.
20. L.L. Ren, Y.M. Wang, Z.Q. Wu, Z.C. Xiang, L. Guo, T. Xu, et al., Identification of a novel coronavirus causing severe pneumonia in human: a descriptive study, Chinese Med J (2020).
21. C. Huang, Y. Wang, X. Li, L. Ren, J. Zhao, Y. Hu, et al., Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China, Lancet 395 (10223) (2020) 497–506.
22. W.G. Carlos, C.S. Dela Cruz, B. Cao, S. Pasnick, S. Jamil, Novel Wuhan (2019-nCoV) coronavirus, Am. J. Respir. Crit. Care Med. 201 (4) (2020) 7–8.
23. J. Lei, J. Li, X. Li, X. Qi, CT imaging of the 2019 novel coronavirus (2019-nCoV) pneumonia, Radiology (2020) 200236.
24. A. Assiri, J.A. Al-Tawfiq, A.A. Al-Rabeeah, F.A. Al-Rabiah, S. Al-Hajjar, A. AlBarrak, et al., Epidemiological, demographic, and clinical characteristics of 47 cases of Middle East respiratory syndrome coronavirus disease from Saudi Arabia: a descriptive study, Lancet Infect. Dis. 13 (2013) 752–761.
25. N. Lee, D. Hui, A. Wu, P. Chan, P. Cameron, G.M. Joynt, et al., A major outbreak of severe acute respiratory syndrome in Hong Kong, N. Engl. J. Med. 348 (2003) 1986–1994.
26. L.T. Phan, T.V. Nguyen, Q.C. Luong, T.V. Nguyen, H.T. Nguyen, H.Q. Le, et al., Importation and human-to-human transmission of a novel coronavirus in Vietnam, N. Engl. J. Med. (2020).
27. Rothan HA, Byrareddy SN. The Epidemiology and Pathogenesis of Coronavirus disease (COVID-19) outbreak. J of Autoimmunity 2020 May; 109:102433.
28. 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. The Lancet. 2020 Feb 15;395(10223):497- 506.
29. 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. The Lancet. 2020 Feb 15;395(10223):507-13.
30. Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, et al. Clinical characteristics of 138 hospitalized patients with 2019 novel coronavirus–infected pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-9.
31. Updated Clinical Management Protocol for COVID-19, dated 22-04-2021. https://www.icmr.gov.in/pdf/covid/techdoc/COVID19_Management_Algorithm_22042021_ v1.pdf.
32. Ge H, Wang X, Yuan X, Xiao G, Wang C, Deng T, et al. The epidemiology and clinical information about COVID-19. European Journal of Clinical Microbiology & Infectious Diseases. 2020 Jun;39(6):1011-9.
33. Huang C, Wang Y, Li X, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet 2020; 395(10223): 497-506.
34. Wang D, Hu B, Hu C, et al. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus–Infected Pneumonia in Wuhan, China. JAMA 2020; 323(11): 1061-9.
35. Young BE, Ong SWX, Kalimuddin S, et al. Epidemiologic Features and Clinical Course of Patients Infected With SARS-CoV-2 in Singapore. JAMA Published online March 3, 2020.
36. Guan WJ, Ni ZY, Hu Y, et al. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med 2020; February 28 (Epub ahead of print).
37. Covid-19 National Emergency Response Center E, Case Management Team KCfDC, Prevention. Early Epidemiological and Clinical Characteristics of 28 Cases of Coronavirus Disease in South Korea. Osong Public Health Res Perspect 2020; 11(1): 8-14.
38. Arentz M, Yim E, Klaff L, et al. Characteristics and Outcomes of 21 Critically Ill Patients With COVID-19 in Washington State. JAMA Published online March 19, 2020.
39. Wu C, Chen X, Cai Y, et al. Risk Factors Associated with Acute Respiratory Distress Syndrome and Death in Patients with Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med Published online March 13, 2020.
40. Buckner, F. S. et al. Clinical features and outcomes of 105 hospitalized patients with COVID-19 in Seattle, Washington. Clin. Infect. Dis. https://doi.org/10.1093/cid/ciaa632 (2020).
41. Xu XW, Wu XX, Jiang XG, Xu KJ, Ying LJ, Ma CL, et al. Clinical findings in a group of patients infected with the 2019 novel coronavirus (SARS-Cov-2) outside of Wuhan, China: retrospective case series. BMJ. 2020 Feb 19;368.
42. Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, et al. Clinical characteristics of 2019 novel coronavirus infection in China. MedRxiv. 2020 Jan 1.
43. 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. The Lancet. 2020 Feb 15;395(10223):497- 506.
44. 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. The Lancet. 2020 Feb 15;395(10223):507-13.
45. Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, et al. Clinical characteristics of 138 hospitalized patients with 2019 novel coronavirus–infected pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-9.
46. Lauer SA, Grantz KH, Bi Q, Jones FK, Zheng Q, Meredith HR, et al. The incubation period of coronavirus disease 2019 (COVID-19) from publicly reported confirmed cases: estimation and application. Annals of Internal Medicine. 2020 May 5;172(9):577-82.
47. Al-Omari A, Rabaan AA, Salih S, Al-Tawfiq JA, Memish ZA. MERS coronavirus outbreak: Implications for emerging viral infections. Diagnostic Microbiology and Infectious Disease. 2019 Mar 1;93(3):265-85.
48. Zhang JJ, Dong X, Cao YY, Yuan YD, Yang YB, Yan YQ, et al. Clinical characteristics of 140 patients infected with SARS‐CoV‐2 in Wuhan, China. Allergy. 2020 Jul;75(7):1730-41.
49. Chung M, Bernheim A, Mei X, Zhang N, Huang M, Zeng X, et al. CT imaging features of 2019 novel coronavirus (2019-nCoV). Radiology. 2020 Apr;295(1):202-7.
50. Shi H, Han X, Jiang N, Cao Y, Alwalid O, Gu J, et al. Radiological findings from 81 patients with COVID-19 pneumonia in Wuhan, China: a descriptive study. The Lancet Infectious Diseases. 2020 Apr 1;20(4):425-34.
51. Covid 19 treatment guidelines by NIH. Available at https://www.covid19treatmentguidelines.nih.gov/
52. Clinical Management Protocol_COVID-19. Jun 2020. Ministry of Health & Family Welfare. Directorate General of Health Services. Available at https://www.mohfw.gov.in/pdf/ClinicalManagementProtocolforCOVID19dated27062020.pd f.
53. Ng JY: Global research trends at the intersection of coronavirus disease 2019 (COVID-19) and traditional, integrative, and complementary and alternative medicine: a bibliometric analysis. BMC Complement Med Ther. 2020;20(1):353.
54. Ang L, Lee HW, Choi JY, et al.: Herbal medicine and pattern identification for treating COVID-19: a rapid review of guidelines. Integr. Med. Res. 2020;9(2):100407.
55. Helfgott Research Institute: Traditional, Complementary and Integrative Health and Medicine COVID-19 Support Registry. (Accessed April 28, 2021).
56. Interdisciplinary AYUSH Research & Development Task Force: Ministry of AYUSH, Government of India. (Accessed 16 April 2021).
57. Adhikari PP, Paul SB: History of Indian traditional medicine: a medical inheritance. Asian J. Pharm. Clin. Res. 2018;11(1):421. 10.22159/ajpcr. 2018.v11i1.21893.
58. Ministry of AYUSH: Ayurveda’s immunity boosting measures for self-care during COVID 19 crisis. (Accessed on 1st April 2021).
59. Ahmad S, Zahiruddin S, Parveen B, et al.: Indian Medicinal Plants and Formulations and Their Potential Against COVID-19–Preclinical and Clinical Research. Front. Pharmacol. 2021; 11:578970.
60. Bhapkar V, Sawant T, Bhalerao S: A critical Analysis of CTRI registered AYUSH studies for COVID- 19. J Ayurveda Integr Med. 2020. 10.1016.
61. Wanjarkhedkar P, Sarade G, Purandare B, et al.: A prospective clinical study of an Ayurveda regimen in COVID 19 patients. J Ayurveda Integr Med. 2020.
62. Chitra SM, Mallika P, Anbu N, et al.: An open clinical evaluation of selected siddha regimen in expediting the management of COVID-19 ea randomized controlled study. J Ayurveda Integr Med. 10.1016/j.jaim.2021.01.002.
63. Devpura G, Tomar BS, Nathiya D, et al.: Randomized placebo-controlled pilot clinical trial on the efficacy of ayurvedic treatment regime on COVID-19 positive patients. Phytomedicine. 2021; 84:153494.
64. Thakar A, Panara K, Patel F, et al.: Add-on Ayurveda Treatment for Early Stage COVID-19: A Single Centre Retrospective Cohort Study from Gujarat, India. J. Evid. Based Integr. Med. 2021;26: 2515690X211020685.
65. Thakar A, Panara K, et al.: Impact of AYUSH interventions on COVID-19: a protocol for a living systematic review and meta-analysis. F1000Res. 2021; 10:674.
66. WHO Director-General’s opening remarks at the media briefing on COVID-19 – 11 March 2020- https://www.who.int/director-general/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-1911-march-2020.
67. https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap accessed 18/01/2021.
68. Warren, T. et al. Nucleotide Prodrug GS-5734 Is a Broad-Spectrum Filovirus Inhibitor That Provides Complete Therapeutic Protection Against the Development of Ebola Virus Disease (EVD) in Infected Non-human Primates. Open Forum Infectious Diseases 2015, 2.
69. Eastman RT, Roth JS. Brimacombe KR, Simeonov A, Shen M, Patnaik S, Hall MD Remdesivir: A Review of its discovery and development leading to emergency use authorization for treatment of COVID-19. ACH Cent. Sci.2020, 6,5,672-683.
70. Bodeker G, Kronenberg F. A public health agenda for traditional, complementary, and alternative medicine. Am J Public Health. 2002;92(10):1582–1591.
71. Balasubramani SP, Venkatasubramanian P, Kukkupuni SK, Patwardhan B. Plant-based Rasayana drugs from Ayurveda. Chin J Integr Med. 2011;17(2):88–94.
72. Agarwal R, Diwanay S, Patki P, Patwardhan B. Studies on immunomodulatory activity of Withania somnifera (Ashwagandha) extracts in experimental immune inflammation. J Ethnopharmacol. 1999; 67:27–35.