Compilation of registered clinical trials for the treatment of COVID-19 infection
Keywords:COVID-19, Clinical trials, Medicines, Novel coronavirus, Coronavirus infection
The Wuhan city, the capital of Hubei province in China became the focal point for origin of virulent disease which later named as COVID-19. This paper aims to analyze the on-going clinical trials for drugs/interventions used for treatment of COVID-19 infection in open domain. The data on ongoing clinical trials on COVID-19 was retrieved from database clinicaltrials.gov. The data extracted includes national clinical trial registry number, title of study, recruitment status, results availability, intervention, outcome measure, sponsorship, study types, study design, start and completion dates, and location. All the extracted data was analyzed. As on 10th August 2020, a total of 2935 trials were registered in different countries. Of which 1115 trials are being conducted in Europe and 640 in United States of America (USA). Majority of COVID-19 clinical trials (95%) were enrolling all age groups including children and older adults. Similarly, majority of trials were including both genders (97%). Among all these clinical trials ongoing on COVID-19, 1645 were interventional, 1266 were observational studies. In interventional study 876 trials used drug intervention. Among all these trials 390 different drug interventions are being tried. Among these hydroxychloroquine, antiretrovirals and angiotensin converting enzyme (ACE) inhibitors were top three drug groups. The conduct of clinical trials in time of pandemic have so many tenacious issues that need to be addressed. It is very important to utilize the resources efficiently such as following a standard protocol then one can easily pool the data of various trials conducted at various places. Given the smaller sample sizes, long completion period, high risk of bias and imprecise information, it will take quite a long time to obtain high quality clinical evidence for the treatment of COVID-19 infection.
Ahmed SS. The Corona Virus Disease 2019 (COVID 19): A Review. J Adv Med Medical Res. 2020;32(4):1-9.
World Health Organization. Available at: www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports. Accessed on: 12 January 2021.
Pascarella G, Strumia A, Piliego C. COVID-19 diagnosis and management: a comprehensive review. J Intern Med. 2020;288(2):192-206.
Zhou F, Yu T, Du R, Fan G, Liu Y, Xiang J, et al. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. The Lancet. 2020;395(10229):1054-62.
Worldometer. Reported Cases and Deaths by Country, Territory, or Conveyance. Available at: https://www.worldometers.info/coronavirus/?utm_campaign=homeAdvegas1. Accessed on: 01 January 2021.
Conti P, Gallenga CE, Tete G, Caraffa A, Ronconi G, Younges A, et al. How to reduce likelihood of coronavirus-19 (CoV-19 or SARS-CoV-2) infection and lung inflammation medicated by IL-1. J Biol Regul Homeost Agents. 2020;34(2):333-8.
Li G, de Clercq E. Therapeutic options for the 2019 novel coronavirus (2019-CoV). Nat Rev Drug Discov. 2020;19(3):149-50.
Clinicaltrials.gov. Available at: https://www. clinicaltrials.gov/ct2/results/map?cond=covid-19&map. Accessed on: 10 August 2020.
National Herald: India- the new global epicentre for COVID-19. Available at: https://www.national heraldindia.com/opinion/india-the-new-global-epicentre-for-covid-19 cited on 27/01/2021. Accessed on: 10 August 2020.
Triggle CR, Bansal D, Farag EABA, Ding H, Sultan AA. COVID-19: Learning from Lessons To Guide Treatment and Prevention Interventions. mSphere. 2020;5(3):317-20.
Stockman LJ, Bellamy R, Garner P. SARS: systematic review of treatment effects. PLoS Med. 2006;3(9):343.
Morra ME, Van Thanh L, Kamel MG. Clinical outcomes of current medical approaches for Middle East respiratory syndrome: a systematic review and meta-analysis. Rev Med Virol. 2018;28(3):e1977.
D'Cruz M. The ICMR bulletin on targeted hydroxychloroquine prophylaxis for Covid-19: Need to interpret with caution. Indian J Med Ethics. 2020;2:100-2.
Gao J, Tian Z, Yang X. Breakthrough: chloroquine phosphate has shown apparent efficacy in treatment of COVID-19 associated pneumonia in clinical studies. Biosci Trends. 2020;14(1):72-3.
Gautret P, Lagier JC, Parola P, Hoang VT, Meddeb L, Mailhe M, et al. Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agents. 2020;56(1):105949.
Aleissa MM, Silverman E, Acosta LMP, Nutt CT, Richterman A, Francisco M. New Perspectives on Antimicrobial Agents: Remdesivir Treatment for COVID-19. Antimicrob Agents Chemother. 2020;65(1):e01814-20.
Gurwitz D. Angiotensin receptor blockers as tentative SARS-CoV-2 therapeutics. Drug Dev Res. 2020;81(5):537-40.
Rico-Mesa JS, White A, Anderson AS. Outcomes in Patients with COVID-19 Infection Taking ACEI/ARB. Curr Cardiol Rep. 2020;22(5):31.
Russell CD, Millar JE, Baillie JK. Clinical evidence does not support corticosteroid treatment for 2019-nCoV lung injury. Lancet. 2020;395(10223):473-5.
Ni YN, Chen G, Sun J, Liang BM, Liang ZA. The effect of corticosteroids on mortality of patients with influenza pneumonia: a systematic review and meta-analysis. Crit Care. 2019;23(1):99.
Wu C, Chen X, Cai Y. Risk factors associated with acute respiratory distress syndrome and death in patients with coronavirus disease 2019 pneumonia in Wuhan, China. JAMA Intern Med. 2020;180(7):934-43.
Wang M, Cao R, Zhang L. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res. 2020;30(3):269-71.
Rossignol JF. Nitazoxanide, a new drug candidate for the treatment of Middle East respiratory syndrome coronavirus. J Infect Public Health. 2016;9(3):227-30.
Mehta P, Ciurtin C, Scully M, Levi M, Chambers RC. JAK inhibitors in COVID-19: the need for vigilance regarding increased inherent thrombotic risk. Eur Respir J. 2020;56(3):2001919.
Singh TU, Parida S, Lingaraju MC, Kesavan M, Kumar D, Singh RK. Drug repurposing approach to fight COVID-19. Pharmacol Rep. 2020;72(6):1479-508.
Winkler AM, Koepsell SA. The use of convalescent plasma to treat emerging infectious diseases: focus on Ebola virus disease. Curr Opin Hematol. 2015;22(6):521-6.
Agarwal A, Mukherjee A, Kumar G, Chatterjee P, Bhatnagar T, Malhotra P; PLACID Trial Collaborators. Convalescent plasma in the management of moderate covid-19 in adults in India: open label phase II multicentre randomised controlled trial (PLACID Trial). BMJ. 2020;371:3939.
Li L, Zhang W, Hu Y, Tong X, Zheng S, Yang J, et al. Effect of Convalescent Plasma Therapy on Time to Clinical Improvement in Patients With Severe and Life-threatening COVID-19: A Randomized Clinical Trial. JAMA. 2020;324(5):460-70.
Shi J, Xiao Y, Zhang Y, Geng D, Cong D, Shi KX, Knapp RJ. Challenges of drug development during the COVID-19 pandemic: Key considerations for clinical trial designs. Br J Clin Pharmacol. 2020.
Zhang T, He Y, Xu W. Clinical trials for the treatment of Coronavirus disease 2019 (COVID-19): A rapid response to urgent need. Sci. China Life Sci. 2020;63(5):774-6.