Use of Neutralizing Monoclonal Antibodies and Its Outcome Measures in COVID-19 Patients

Moniruddin Chowdhury^1,2, Syeda Humayra², Taha Sulayman³, Keichiro Mihara⁴, P.K. Rajesh¹

The use of monoclonal antibodies in Covid-19.

Abstract

Neutralizing monoclonal antibodies (mAbs) can stimulate protective immunity. Hence their rapid identification and characterization are incorporated into clinical practice to provide effective treatment and prophylaxis during the COVID-19 pandemic. Previously, mAbs have been effectively used in several other viral infections, including Ebola, influenza, HIV, RSV, Zika virus, and MERS-CoV. Currently, the utilization of mAbs appears to have favorable clinical outcomes in patients with mild-moderate SARS-CoV-2 infection, particularly individuals at high risk of hospitalization and progression to severe COVID-19. However, most of the interim results on anti-SARS-CoV-2 mAbs are based on ongoing clinical trial data; thereby, several questions revolve around this novel therapy, including its long-term implication, application, and feasibility. Although, the use of neutralizing mAbs may assist in alleviating the critical burden on healthcare settings and minimizing hospital stay due to severe progression of the COVID-19 symptoms especially among those with poor immune responses to vaccination, elderly, and/or vaccine-refractory individuals. Nonetheless, there is a broader need to explore these novel therapies for their effective use in clinical practice and to improve patient-related outcomes. 

Keywords: Monoclonal antibodies, mAb, anti-SARS-CoV-2, COVID-19, prophylaxis, outcome

References

Abani, O., Abbas, A., Abbas, F., Abbas, M., Abbasi, S., Abbass, H., ... & Ali, M. (2021). Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. The Lancet, 397(10285), 1637-1645.

Bariola, J. R., McCreary, E. K., Wadas, R. J., Kip, K. E., Marroquin, O. C., Minnier, T., ... & Snyder, G. M. (2021, July). Impact of bamlanivimab monoclonal antibody treatment on hospitalization and mortality among nonhospitalized adults with severe acute respiratory syndrome coronavirus 2 infection. In Open forum infectious diseases (Vol. 8, No. 7, p. ofab254). US: Oxford University Press.

Case, J. B., Winkler, E. S., Errico, J. M., & Diamond, M. S. (2021). On the road to ending the COVID-19 pandemic: Are we there yet?. Virology, 557, 70-85.

Chen, P., Nirula, A., Heller, B., Gottlieb, R. L., Boscia, J., Morris, J., ... & Skovronsky, D. M. (2021). SARS-CoV-2 neutralizing antibody LY-CoV555 in outpatients with Covid-19. New England Journal of Medicine, 384(3), 229-237.

Corti, D., Purcell, L. A., Snell, G., & Veesler, D. (2021). Tackling COVID-19 with neutralizing monoclonal antibodies. Cell, 184(12), 3086-3108.

Deb, P., Molla, M. M. A., & Saif-Ur-Rahman, K. M. (2021). An update to monoclonal antibody as therapeutic option against COVID-19. Biosafety and Health, 3(2), 87-91.

Díaz, Y., Ramos-Suzarte, M., Martín, Y., Calderón, N. A., Santiago, W., Viñet, O., ... & Hidalgo, C. J. (2020). Use of a humanized anti-CD6 monoclonal antibody (itolizumab) in elderly patients with moderate COVID-19. Gerontology, 66(6), 553-561.

European Medicines Agency (EMA). (2021). EMA starts rolling review of sotrovimab (VIR-7831) for COVID-19. [Cited 2021 May 30] Available from: https://www.ema.europa.eu/en/news/ema-starts-rolling-review-sotrovimab-vir-7831-covid-19.

FDA. (2021). Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19. [Cited 2021 May 29]. Available from: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibodies-treatment-covid-19.

Gottlieb, R. L., Nirula, A., Chen, P., Boscia, J., Heller, B., Morris, J., ... & Skovronsky, D. M. (2021). 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, 325(7), 632-644.

Gupta, S., & Leaf, D. E. (2021). Tocilizumab in COVID-19: some clarity amid controversy. The Lancet, 397(10285), 1599-1601.

Gupta, A., Gonzalez-Rojas, Y., Juarez, E., Crespo Casal, M., Moya, J., Falci, D. R., ... & Shapiro, A. E. (2021). Early treatment for Covid-19 with SARS-CoV-2 neutralizing antibody sotrovimab. New England Journal of Medicine, 385(21), 1941-1950.

Jaworski, J. P. (2021). Neutralizing monoclonal antibodies for COVID-19 treatment and prevention. biomedical journal, 44(1), 7-17.

Lloyd, E. C., Gandhi, T. N., & Petty, L. A. (2021). Monoclonal antibodies for COVID-19. JAMA, 325(10), 1015-1015.

Lundgren, J. D., Grund, B., Barkauskas, C. E., Holland, T. L., Gottlieb, R. L., … & Neaton. J. D. (2021). A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19. New England Journal of Medicine, 384(10), 905-914.

Marovich, M., Mascola, J. R., & Cohen, M. S. (2020). Monoclonal antibodies for prevention and treatment of COVID-19. Jama, 324(2), 131-132.

Monoclonal Antibodies. (2021). Covid-19 Real-time learning network. [Cited 2021 May 28]. Available from: https://www.idsociety.org/covid-19-real-time-learning-network/therapeutics-and-interventions/monoclonal-antibodies/.

Nature. (2021). COVID antibody treatments show promise for preventing severe disease. [Cited 2021 May 30]. Available from: https://www.nature.com/articles/d41586-021-00650-7.

NIH.( 2021). Anti-SARS-CoV-2 Monoclonal Antibodies COVID-19 Treatment Guidelines. [Cited 2021 May 29. Available from: https://www.covid19treatmentguidelines.nih.gov/anti-sars-cov-2-antibody-products/anti-sars-cov-2-monoclonal-antibodies/.

Ning, L., Abagna, H. B., Jiang, Q., Liu, S., & Huang, J. (2021). Development and application of therapeutic antibodies against COVID-19. International Journal of Biological Sciences, 17(6), 1486.

Pharmaceutical Techonology. (2021). FDA grants EUA to GSK and Vir’s sotrovimab for Covid-19. [Cited 2021 May 30]. Available from: https://www.pharmaceutical-technology.com/news/gsk-vir-sotrovimab-eua/.

Razonable, R. R., & Chen, P. (2022). Neutralizing Antibodies in the Prevention and Treatment of COVID-19. Frontiers in Immunology, 2796.

Reichert J. (2021). Anti-IL-6R levilimab registered as COVID-19 treatment in Russia. [Interent]. The Antibody Society. [Cited 2021 Jun 27]. Available from: https://www.antibodysociety.org/approvals/anti-il-6r-levilimab-registered-as-covid-19-treatment-in-russia/

Rosas, I. O., Bräu, N., Waters, M., Go, R. C., Hunter, B. D., Bhagani, S., ... & Malhotra, A. (2021). Tocilizumab in hospitalized patients with severe Covid-19 pneumonia. New England Journal of Medicine, 384(16), 1503-1516.

Ryu, D. K., Song, R., Kim, M., Kim, Y. I., Kim, C., Kim, J. I., ... & Lee, S. Y. (2021). Therapeutic effect of CT-P59 against SARS-CoV-2 South African variant. Biochemical and biophysical research communications, 566, 135-140.

Scourfield, D. O., Reed, S. G., Quastel, M., Alderson, J., Bart, V. M., Teijeira Crespo, A., ... & Burnell, S. E. (2021). The role and uses of antibodies in COVID-19 infections: A living review. Oxford Open Immunology, 2(1), iqab003.

Taylor, P. C., Adams, A. C., Hufford, M. M., De La Torre, I., Winthrop, K., & Gottlieb, R. L. (2021). Neutralizing monoclonal antibodies for treatment of COVID-19. Nature Reviews Immunology, 21(6), 382-393.

The Antibody Society. (2021). COVID-19 Archives. [Cited 2021 May 30]. Available from: https://www.antibodysociety.org/covid-19/.

UPMC. (2021). COVID-19 Monoclonal Antibodies Reduce Risk of Hospitalization, Death. [Cited 2021 May 29]. Available from: https://www.upmc.com/media/news/051721-bariola-mab-ofid.

Valdez-Cruz, N. A., Garcia-Hernandez, E., Espitia, C., Cobos-Marín, L., Altamirano, C., Bando-Campos, C. G., ... & Trujillo-Roldan, M. A. (2021). Integrative overview of antibodies against SARS-CoV-2 and their possible applications in COVID-19 prophylaxis and treatment. Microbial cell factories, 20(1), 1-32.

Zhou, Y., & Wei, H. (2020). Tocilizumab is recommended for the treatment of severe COVID-19. EBioMedicine, 61.