Updated mini-review of the chemistry, pharmacology and validated assays for U.S. FDA approved COVID-19 therapeutic agents

Miranda F. Kamal, Mohamed S. Nasr, Yousef S. Elshamy, Nehal W. El Sayed, Sara M. Mohyeldin


The fish market in Wuhan, China was the epicenter of Covid-19 pandemic, brought about by SARS-Co-V-2.  The latter has radiated worldwide, resulting in significant economic and social disruption “Covid Crisis”.  Although numerous drugs have been indicated for treating the viral infection and/or its symptoms, U.S. FDA has granted approvals for only three therapeutic agents; Remdesivir, Baricitinib and Monoclonal Antibodies (Bamlanivimab/Etesevimab, Casirivimab/Imdevimab).  This review assigns the approved drug entities with respect to their chemical and pharmacological aspects as well as their reported analyses in marketed formulations and biological matrices.  Furthermore, it offers a comparative study between the cited analytical methodologies for each drug separately.  A comprehensive, detailed, yet an instant message of Coronavirus authorized cure is delivered throughout the presented review.


Covid-19; Remdesivir; Baricitinib; Monoclonal antibodies

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Rabi, F.A., M.S. Al Zoubi, G.A. Kasasbeh, et al." SARS-CoV-2 and coronavirus disease 2019: What we know so far." Pathogens,vol. 9,issue 3,pp.,2020.

Lai, C.C., T.P. Shih, W.C. Ko, et al." Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and coronavirus disease-2019 (COVID-19): The epidemic and the challenges." Int J Antimicrob Agents,vol. 55,issue 3,pp. 105924,2020.

WHO Director-General’s remarks at the media briefing on 2019-nCoV on 11 February 2020.

Sohrabi, C., Z. Alsafi, N. O'Neill, et al." World Health Organization declares global emergency: A review of the 2019 novel coronavirus (COVID-19)." International journal of surgery,vol. 76,issue,pp. 71-76,2020.

Weiskopf, D., K.S. Schmitz, M.P. Raadsen, et al." Phenotype of SARS-CoV-2-specific T-cells in COVID-19 patients with acute respiratory distress syndrome." medRxivZx ,2020.

Li, H., L. Liu, D. Zhang, et al." SARS-CoV-2 and viral sepsis: observations and hypotheses." Lancet,vol. 395,issue 10235,pp. 1517-1520,2020.

Sanders, J.M., M.L. Monogue, T.Z. Jodlowski, et al." Pharmacologic Treatments for Coronavirus Disease 2019 (COVID-19): A Review." JAMA,vol. 323,issue 18,pp. 1824-1836,2020.

Astuti, I. and Ysrafil." Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2): An overview of viral structure and host response." Diabetes Metab Syndr,vol. 14,issue 4,pp. 407-412,2020.

Zhang, H., J.M. Penninger, Y. Li, et al." Angiotensin-converting enzyme 2 (ACE2) as a SARS-CoV-2 receptor: molecular mechanisms and potential therapeutic target." Intensive Care Med,vol. 46,issue 4,pp. 586-590,2020.

Liu, C., Q. Zhou, Y. Li, et al." Research and Development on Therapeutic Agents and Vaccines for COVID-19 and Related Human Coronavirus Diseases." ACS Central Science,vol. 6,issue 3,pp. 315-331,2020.

Shi, Y., X. Zhang, K. Mu, et al." D3Targets-2019-nCoV: a webserver for predicting drug targets and for multi-target and multi-site based virtual screening against COVID-19." Acta Pharmaceutica Sinica B,vol. 10,issue 7,pp. 1239-1248,2020.

Alhazzani, W., M.H. Møller, Y.M. Arabi, et al." Surviving Sepsis Campaign: guidelines on the management of critically ill adults with Coronavirus Disease 2019 (COVID-19)." Intensive Care Med,vol. 46,issue 5,pp. 854-887,2020.

Hamid, S., M.Y. Mir, and G.K. Rohela." Novel coronavirus disease (COVID-19): a pandemic (epidemiology, pathogenesis and potential therapeutics)." New microbes and new infections,vol. 35,2020.

Lythgoe, M.P. and P. Middleton." Ongoing Clinical Trials for the Management of the COVID-19 Pandemic." Trends Pharmacol Sci,vol. 41,issue 6,pp. 363-382,2020.

Eastman, R.T., J.S. Roth, K.R. Brimacombe, et al." Remdesivir: A Review of Its discovery and development leading to emergency use authorization for treatment of COVID-19." ACS Central Science,vol. 6,issue 5,pp. 672-683,2020.

DrugBank. Remdesivir. https://www.drugbank.ca/drugs/DB14761 (accessed April 26, 2020).

Jorgensen, S.C.J., R. Kebriaei, and L.D. Dresser." Remdesivir: Review of Pharmacology, Pre-clinical Data, and Emerging Clinical Experience for COVID-19." Pharmacotherapy,vol. 40,issue 7,pp. 659-671,2020.

Amirian, E.S. and J.K. Levy." Current knowledge about the antivirals remdesivir (GS-5734) and GS-441524 as therapeutic options for coronaviruses." One Health,vol. 9,p. 100128,2020.

Warren, T.K., R. Jordan, M.K. Lo, et al." Therapeutic efficacy of the small molecule GS-5734 against Ebola virus in rhesus monkeys." Nature,vol. 531,issue 7594,pp. 381-385,2016.

Alvarez, J.C., P. Moine, I. Etting, et al." Quantification of plasma remdesivir and its metabolite GS-441524 using liquid chromatography coupled to tandem mass spectrometry. Application to a Covid-19 treated patient." Clin Chem Lab Med,vol. 58,issue 9,pp. 1461-1468,2020.

Humeniuk, R., A. Mathias, H. Cao, et al." Safety, tolerability, and pharmacokinetics of remdesivir, An antiviral for treatment of COVID-19, in healthy subjects." Clinical and Translational Science,vol. 13,issue 5,pp. 896-906,2020.

Pasupuleti, R.R., P.-C. Tsai, V.K. Ponnusamy, et al." Rapid determination of remdesivir (SARS-CoV-2 drug) in human plasma for therapeutic drug monitoring in COVID-19-Patients." Process Biochemistry,vol. 102,pp. 150-156,2021.

Avataneo, V., A. de Nicolò, J. Cusato, et al." Development and validation of a UHPLC-MS/MS method for quantification of the prodrug remdesivir and its metabolite GS-441524: a tool for clinical pharmacokinetics of SARS-CoV-2/COVID-19 and Ebola virus disease." J Antimicrob Chemother,vol. 75,issue 7,pp. 1772-1777,2020.

Tempestilli, M., P. Caputi, V. Avataneo, et al." Pharmacokinetics of remdesivir and GS-441524 in two critically ill patients who recovered from COVID-19." J Antimicrob Chemother,vol. 75,issue 10,pp. 2977-2980,2020.

Taylor, P.C., E.C. Keystone, D. van der Heijde, et al." Baricitinib versus placebo or adalimumab in rheumatoid arthritis." New England Journal of Medicine,vol. 376,issue 7,pp. 652-662,2017.

DrugBank. Baricitinib. https://go.drugbank.com/drugs/DB11817 (accessed April 30, 2020).

Jorgensen, S.C., C.L. Tse, L. Burry, et al." Baricitinib: a review of pharmacology, safety, and emerging clinical experience in COVID‐19." Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy,vol. 40,issue 8,pp. 843-856,2020.

Kalil, A.C., T.F. Patterson, A.K. Mehta, et al." Baricitinib plus remdesivir for hospitalized adults with COVID-19." New England Journal of Medicine,vol. 384,issue 9,pp. 795-807,2020.

Zhang, X., Y. Zhang, W. Qiao, et al." Baricitinib, a drug with potential effect to prevent SARS-COV-2 from entering target cells and control cytokine storm induced by COVID-19." Int Immunopharmacol,vol. 86,p. 106749,2020.

Luo, W., Y.-X. Li, L.-J. Jiang, et al." Targeting JAK-STAT signaling to control cytokine release syndrome in COVID-19." Trends in pharmacological sciences,2020.

Hoang, T.N., M. Pino, A.K. Boddapati, et al." Baricitinib treatment resolves lower-airway macrophage inflammation and neutrophil recruitment in SARS-CoV-2-infected rhesus macaques." Cell,vol. 184,issue 2,pp. 460-475 e421,2021.

Veeraraghavan, S., S.R. Thappali, S. Viswanadha, et al." Simultaneous Quantification of Baricitinib and Methotrexate in Rat Plasma by LC-MS/MS: Application to a Pharmacokinetic Study." Sci Pharm,vol. 84,issue 2,pp. 347-359,2016.

Ezzeldin, E., M. Iqbal, Y.A. Asiri, et al." A Hydrophilic interaction liquid chromatography-tandem mass spectrometry quantitative method for determination of baricitinib in plasma, and Its application in a pharmacokinetic study in rats." Molecules (Basel, Switzerland),vol. 25,issue 7,p. 1600,2020.

Gandhi, S.V. and B.G. Kapoor." Development and validation of UV spectroscopic method for estimation of baricitinib." Journal of Drug Delivery and Therapeutics,vol. 9,issue 4-s,pp. 488-491,2019.

Mohan, S., N. Srinivasarao, and K. Lakshmi." Development and validation of a stability indicating related substances of baricitinib by RP-HPLC and its degradation." Int. J. Manag. Hum,vol. 4,pp. 4-9,2019.

Breedveld, F.C." Therapeutic monoclonal antibodies." Lancet,vol. 355,issue 9205,pp. 735-740,2000.

Taylor, P.C., A.C. Adams, M.M. Hufford, et al." Neutralizing monoclonal antibodies for treatment of COVID-19." Nature Reviews Immunology,2021.

Gottlieb, R.L., A. Nirula, P. Chen, et al." Effect of bamlanivimab as monotherapy or in combination With etesevimab on viral load in patients with mild to moderate COVID-19: A randomized clinical trial." JAMA,vol. 325,issue 7,pp. 632-644,2021.

Webb, B.J., W. Buckel, T. Vento, et al." Real-world effectiveness and tolerability of monoclonal antibodies for ambulatory patients with early COVID-19." medRxiv,2021.

DOI: http://dx.doi.org/10.21622/ampdr.2022.02.1.001


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Copyright (c) 2022 Miranda F. Kamal, Mohamed S. Nasr, Yousef S. Elshamy, Sara M. Mohyeldin, Nehal w. El Sayed

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Advances in Medical, Pharmaceutical and Dental Research
E-ISSN: 2812-4898
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