Media Release

31.07.2021

Neutralizing monoclonal Antibodies (NmAbs) for COVID-19 treatment Experts reveal can help ease hospital bed shortage, according to international studies

monoclonal antibodies


Bangkok, Thailand
– The COVID-19 situation in Thailand continues to escalate, with rising economic and healthcare implications. Thus, the ongoing race for shorter hospitalisation time and earlier patient discharge is crucial for alleviating the healthcare burden and national hospital bed shortage present across the country.  

The antibody cocktail, classified as Neutralizing monoclonal Antibodies (NmAbs), presents an option for the treatment of COVID-19. Approved under an Emergency Use Authorization (EUA) from the Thai Food and Drug Administration (FDA) on July 15, 2021, the antibody cocktail has been proven to reduce hospitalisation time significantly, with references from real-world evidence and clinical trials conducted in the United States.

 

Prof. Manop Pithukpakorn, MD, President, Center of Research Excellence in Precision Medicine, Faculty of Medicine, Siriraj Hospital, provided information regarding the Neutralizing monoclonal Antibodies (NmAbs), particularly the antibody cocktail that, “The antibody cocktail contains two monoclonal antibodies and is administered as a single intravenous infusion. The combination consists of antibodies produced by the VelocImmune® mice which have been genetically modified to have a human immune system, and antibodies identified from humans who have recovered from COVID-19. The antibody cocktail exhibits a key mechanism of action by binding simultaneously and independently to the spike protein receptor of SARS-CoV-2, leading to an inhibition of infection of host cells.”
 

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“The antibody cocktail and vaccines differ. Vaccines are meant for pre-exposure prophylaxis or a preventive measure for people who have not exposed to the virus, while the antibody cocktail is recommended for treating patients with mild to moderate COVID-19 that do not require oxygen supplementation, as well as patients who are at major risk of severe or progressing to severe COVID-19,” Prof. Manop added.
 

Based on Phase III trial assessing the antibody cocktail in ambulatory COVID-19 patients[1], Prof. Sasisopin Kiertiburanakul, MD, Department of Infectious Diseases, Faculty of Medicine, Ramathibodi Hospital revealed that, “The trial was conducted on more than non-hospitalised mild to moderate 4,000 COVID-19 patients who have exhibited symptoms for no more than 7 days. The 1,200 mg doses show significant viral load reductions, minimise the risk of progressing to severe COVID-19 or death by 70%, and shorten the duration of symptoms by four days.[2] Possible signs of infusion-related reactions may include anaphylaxis or hypersensitivity.”

Although in vitro studies from the National Institutes of Health (NIH)[1] suggest that the antibody cocktail is susceptible to emerging SARS-CoV-2 variants, such as Beta, Alpha, Gamma and Delta, there are no in vivo efficacy as of now.
 

Weerawat Manosuthi, MD, Vice Director, Bamrasnaradura Infectious Diseases Institute, mentioned that the National Institutes of Health (NIH) and the Infectious Diseases Society of America (IDSA)[1] have issued new treatment guidelines for the clinical management of mild to moderate COVID-19 patients and patients who are at high risk of severe or progressing to severe COVID-19, by recommending the use of said antibody cocktail under Emergency Use Authorization (EUA).

In addition, real world evidence[1] [2] [3], collected from several US states, namely Florida, Georgia, Southern Minnesota, Iowa, Wisconsin and Arizona, indicates that, “Within 30 days of receiving Neutralising monoclonal Antibodies versus placebo, patients who are at high risk of severe or progressing to severe COVID-19 show the decrease in admission rates and / or Emergency Department (ED) visits, and deaths,” said Weerawat, MD. Therefore, the antibody cocktail presents an option for COVID-19 treatment amid the pandemic, reducing the implications and expanding opportunities for earlier access to proper medical care for infected patients, due to shorter bed occupancy rate.

 “As the antibody cocktail became available to the COVID-19 patients in Thailand, it is imperative that involving stakeholders closely monitor and examine the treatment outcomes, in order to assess its appropriate use and potential guidelines for the future,” Weerawat, MD, concluded.







Referance:

[1] https://clinicaltrials.gov/ct2/show/NCT04425629
[2] https://www.google.com/url?q=https://www.roche.co.th/content/dam/rochexx/roche-th/disease-areas/covid/%25E0%25B9%2580%25E0%
25B8%25AD%25E0%25B8%2581%25E0%25B8%25AA%25E0%25B8%25B2%25E0%25B8%25A3%25E0%25B8%2581%25E0%25B8%25B3%25E0%25B8%
2581%25E0%25B8%25B1%25E0%25B8%259A%25E0%25B8%25A2%25E0%25B8%25B2%2520%25E0%25B8%25A0%25E0%25B8%25B2%25E0%25B8%25A9%25E0%25B8%25B2%25E0%25B9%2584%25E0%25B8%
2597%25E0%25B8%25A2%2520FINAL%2520%25E0%25B8%25A7%25E0%25B8%25B1%25E0%25B8%
2599%25E0%25B8%2597%25E0%25B8%25B5%25E0%25B9%2588%252013%2520%25E0%25B8%
2581%25E0%25B8%2584%25202021.pdf&sa=D&source=editors&ust=1628583953051737&usg=AOvVaw1o67sDPs_bYTEfcnzkUZlP
[3] https://www.covid19treatmentguidelines.nih.gov/therapies/anti-sars-cov-2-antibody-products/anti-sars-cov-2-monoclonal-antibodies/
[4] https://www.google.com/url?q=https://www.covid19treatmentguidelines.nih.gov/therapies/anti-sars-cov-2-antibody-products/anti-sars-cov-2-monoclonal-antibodies/&sa=D&source=editors&ust=1628583953061896&usg=AOvVaw2cd-daONDAscCtqrw577b7
[5] https://www.google.com/url?q=https://www.google.com/url?q%3Dhttps://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/%26sa%3DD%26source%3Deditors%26ust%3D1627574352684000%26usg%3DAFQjCNHWjHbPkcY7BGv-B9-ZopqpoCdi-Q&sa=D&source=editors&ust=1628583953063416&usg=AOvVaw22l9Cjs07S54kFqD0xRvZq
[6] Piccicacco N et al. Open Forum Infectious Diseases, Volume 8, Issue 7, July 2021, ofab292, https://doi.org/10.1093/ofid/ofab292
[7] Anderson B. et al Open Forum Infect Dis. 2021 Jul; 8(7): ofab315.Published online 2021 Jun 12. doi: 10.1093/ofid/ofab315
[8] Verderese JP et al. Published by Oxford University Press for the Infectious Diseases Society of America.


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