Monoclonal antibodies in COVID-19 management: a scoping review
DOI:
https://doi.org/10.18203/2319-2003.ijbcp20213645Keywords:
COVID-19, Bamlanivimab, Etesevimab, Casirivimab, Imdevimab, mAbsAbstract
Coronavirus disease 2019 (COVID-19) was declared as pandemic on March 11th 2020 by the world health organization (WHO). Vaccination is for preventing COVID-19 morbidity but when people are infected, treatment is required and even after one and half years the effective cure is yet to be discovered. In this context monoclonal antibodies (mAbs) are promising innovative therapeutic agents in controlling COVID-19 infection. Researchers have found more than 50 mAbs against COVID-19 and they are at different stages of development. Scientists are pacing the research on mAbs. mAbs are innovative therapeutic agents in this context a scoping narrative review was done. At present we have evidences from numerous randomized controlled trials (RCT) on mAbs in effective control of respiratory and coagulation related complications due to COVID-19 infection. Many have got emergency use approval and few of which were withdrawn due to absence of enough evidences or adverse reactions. Examples are bamlanivimab, etesevimab, casirivimab and imdevimab. Other than these many investigational (mAbs) are under scrutiny. With the current evidences the article will give an insight to new and repurposed mAbs which are still under investigation in the management of COVID-19 infections.
Metrics
References
Cherumanalil JM, Thayyil J. Pharmacological treatments of COVID-19-A Review. Asian J Pharm Clin Res. 2020;13(10):16-22.
WHO Coronavirus (COVID-19) Dashboard. Available at: https://covid19.who.int. Accessed on 1 March 2020.
Jahanshahlu L, Rezaei N. Monoclonal antibody as a potential anti-COVID-19. Biomedicine pharmacotherapy. 2020;129:110337.
Therapeutic Management. COVID-19 Treatment Guidelines. Available at: https://www.covid19 treatmentguidelines.nih.gov/management/therapeutic-management/. Accessed on 1 March 2020.
Cao X. COVID-19: immunopathology and its implications for therapy. Nat Rev Immunol. 2020 Apr 9;1–2.
Van Eijk LE, Binkhorst M, Bourgonje AR, Offringa AK, Mulder DJ, Bos EM et al. COVID-19: immunopathology, pathophysiological mechanisms, and treatment options. J Pathol. 2021;254(4):307-31.
Binkhorst M. Offringa AK, Hoeven VJG. COVID-19: Comprehensive Synopsis of Suggested Pathophysiological Mechanisms and Repurposed Drugs. Preprints 2020;2020070108.
Conti P, Pregliasco FE, Calvisi V, Caraffa Al, Gallenga CE, Kritas SK et al. Monoclonal antibody therapy in COVID-19. J Biol Regul Homeost Agents. 2021;35(2):423-7.
Shanmugaraj B, Siriwattananon K, Wangkanont K, Phoolcharoen W. Perspectives on monoclonal antibody therapy as potential therapeutic intervention for Coronavirus disease-19 (COVID-19). Asian Pac J Allergy Immunol. 2020;38(1):10-8.
Dougan M, Nirula A, Azizad M, Mocherla B, Gottlieb RL, Chen P et al. BLAZE-1 Investigators. Bamlanivimab plus Etesevimab in Mild or Moderate COVID-19. N Engl J Med. 2021;NEJMoa2102685.
Bamlanivimab (LY-Cov555) for the Treatment of COVID-19, USA. Available at: https://www. clinicaltrialsarena.com/projects/bamlanivimab-ly-cov555-for-the-treatment-of-covid-19/. Accessed on 1 March 2020.
Emergency use authorisation FDA. Feb 25, 2021. Available at: https://www.fda.gov/media/145801/. Accessed on 1 March 2020.
Gottlieb RL, Nirula A, Chen P, Boscia J, Heller B, Morris J 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. 2021;325(7):632.
PHE. Available at: https://www.phe.gov/ emergency/events/COVID19/investigation-MCM/ Bamlanivimab-etesevimab/Pages/bamlanivimab-etesevimab-distribution-pause.aspx/. Accessed on 1 March 2020.
REGEN-COV (Casirivimab with Imdevimab) to treat COVID-19, USA. Available at: https://www.clinical trialsarena.com/projects/regen-cov-casirivimab-imdevimab/. Accessed on 1 March 2020.
O’Brien MP, Forleo-Neto E, Musser BJ, Isa F, Chan KC, Sarkar N et al. The COVID-19 phase 3 prevention trial team. Subcutaneous REGEN-COV Antibody Combination to Prevent COVID-19: August 4, 2021. N Engl J Med. 2021;384:238-51.
Weinreich DM, Sivapalasingam S, Norton T, Ali S, Gao H, Bhore R et al. The Trial Investigators. REGN-COV2, a Neutralizing Antibody Cocktail, in Outpatients with COVID-19: 2019;Moa2035002.
Sotrovimab. Emergency Use Authorization (EUA) Information for HCPs. Available at: https://www.sotrovimab.com/. Accessed on 1 March 2020.
Sotrovimab Clinical, Safety and Variant Info. EUA Info for HCPs. Available at: https://www.sotrov-imab.com/hcp/clinical-safety-variant-info/. Accessed on 1 March 2020.
Gupta A, Gonzalez-Rojas Y, Juarez E, Casal MC, Moya J, Falci DR et al. Early COVID-19 Treatment With SARS-CoV-2 Neutralizing Antibody Sotrovimab. medRxiv. 2021.
Daily Med-SOTROVIMAB injection, solution, concentrate. Available at: https://dailymed.nlm. nih.gov/dailymed/lookup.cfm?setid=aa5cca2e-4351-4f81-b0e5-3303ac0b2474&version=1/. Accessed on 1 March 2020.
Huizinga TWJ, Fleischmann RM, Jasson M, Radin AR, Van Adelsberg J, Fiore S et al. Sarilumab, a fully human monoclonal antibody against IL-6Rα in patients with rheumatoid arthritis and an inadequate response to methotrexate: efficacy and safety results from the randomised SARIL-RA-MOBILITY Part A trial. Ann Rheum Dis. 2014;73(9):1626-34.
Generic Name: Sarilumab; Drug Bank Accession Number: DB11767. Available at: https://go.drug bank.com/drugs/DB11767/. Accessed on 10 March 2020.
Lescure F-X, Honda H, Fowler RA, Lazar JS, Shi G, Wung P et al. Sarilumab in patients admitted to hospital with severe or critical COVID-19: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med. 2021;9(5):522-32.
Sanofi: Press Releases, Tuesday, September 1, 2020. Available at: https://www.sanofi.com/en/media-room/press-releases/2020/2020-09-01-07-00-00/. Accessed on 10 March 2020.
GlaxoSmithKline. A Randomized, Double-blind, Placebo-controlled, Study Evaluating the Efficacy and Safety of Otilimab IV in Patients with Severe Pulmonary COVID-19 Related Disease. clinicaltrials.gov; 2021 Apr. Report No.: NCT04376684. Available at: https://clinicaltrials.gov/ct2/show/NCT04376684/. Accessed on 11 March 2020.
GSK announces results evaluating its investigational monoclonal antibody, otilimab, for the treatment of hospitalised adult patients with COVID-19. GSK. Available at: https://www.gsk.com/en-gb/media/ press-releases/gsk-announces-otilimab-data-for-treatment-of-covid-19/. Accessed on 11 March 2020.
First patient in OSCAR trial receives GSK’s otilimab in UK. Available at: https://www.clinicaltrial sarena.com/news/gsk-oscar-trial-uk/. Accessed on 11 March 2020.
Lenzilumab. Available at: https://en.wikipedia.org /w/index.php?title=Lenzilumab&oldid=1033018584"oldid=1033018584/. Accessed on 1 March 2020.
Temesgen Z, Burger CD, Baker J, Polk C, Libertin C, Kelley C, et al. Lenzilumab efficacy and safety in newly hospitalized COVID-19 subjects: results from the live-air phase 3 randomized double-blind placebo-controlled trial. medRxiv. 2021.
Pharmaceutical Review. Available at: https://www.europeanpharmaceuticalreview.com/news/149326/lenzilumab-significantly-improves-survival-in-hospitalised-covid-19-patients/. Accessed on 11 March 2020.
Lenzilumab efficacy and safety in newly hospitalized COVID-19 subjects: results from the live-air phase 3 randomized double-blind placebo-controlled trial. Medrxiv prepr serv health sci. 2021.
Johns Hopkins University. Crizanlizumab for Treating COVID-19 Vasculopathy. 2021.
Ataga KI, Kutlar A, Kanter J, Liles D, Cancado R, Friedrisch J et al. Crizanlizumab for the Prevention of Pain Crises in Sickle Cell Disease. N Engl J Med. 2017;376(5):429-39.
Stern RM, Connell NT. Ravulizumab: a novel C5 inhibitor for the treatment of paroxysmal nocturnal hemoglobinuria. Ther Adv Hematol. 2019;10:2040620719874728.
Long-Term Efficacy and Safety of the Long-Acting Complement C5 Inhibitor Ravulizumab for the Treatment of Atypical Hemolytic Uremic Syndrome in Adults. Kidney Int Rep. 2021;6(6):1603-13.
Leronlimab in Critically Ill Patients with Coronavirus Disease 2019 (COVID-19) With Need for Mechanical Ventilation or Extracorporeal Membrane Oxygenation: Clinical Trials.gov identifier. 2020;NCT04901689.
Yang B, Fulcher JA, Ahn J, Berro M, Goodman-Meza D, Dhody K et al. Clinical Characteristics and Outcomes of COVID-19 Patients Receiving Compassionate Use Leronlimab. Clin Infect Dis. 2020:ciaa1583.