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Convalescent Plasma and Antibody Therapy in COVID-19
Published in Debmalya Barh, Kenneth Lundstrom, COVID-19, 2022
Didem Rıfkı, Eymen Ü. Kılıç, Şükrü Tüzmen
Bamlanivimab has been approved by the FDA for the care of non-hospitalized adults and children aged 12 years and above and weighing 40 kg who are at high risk of developing extreme COVID-19 or requiring hospitalization. Safety protocols for bamlanivimab can be found in Table 8.1.
Neutralizing anti-spike monoclonal antibodies for COVID-19 in vulnerable populations: lessons learned and future directions
Published in Expert Opinion on Biological Therapy, 2023
As bamlanivimab was made available in the clinical setting, outpatient COVID-19 infusion therapy programs were established [1]. The clinical benefits of bamlanivimab treatment of high-risk patients with mild-to-moderate COVID-19 were subsequently demonstrated in real-world studies [15–17]. In one of these studies that compared the outcomes of 2335 high-risk patients who received bamlanivimab and a propensity-matched control of 2335 untreated high-risk patients, bamlanivimab was significantly associated with reduction in all-cause hospitalization at days 14 (1.5% versus 3.5%) and 28 (2.5% versus 3.9%, respectively) after infusion. There were also significantly lower rates of intensive care unit (ICU) admission and death among bamlanivimab-treated patients compared to propensity-matched untreated high-risk patients [15].
Therapeutic monoclonal antibodies for COVID-19 management: an update
Published in Expert Opinion on Biological Therapy, 2022
Vivek P Chavda, Riddhi Prajapati, Disha Lathigara, Bhumi Nagar, Jay Kukadiya, Elrashdy M Redwan, Vladimir N Uversky, Mukesh N Kher, Rajvi Patel
Bamlanivimab targets RBD of viral S protein and prevents the attachment of Sprotein with the human ACE2 (a cell surface protein). On 7 October 2020, Eli Lilly declared that they had submitted a EUA request for monotherapy in patients who are at high risk, while the FDA authorized its emergency use on 9 November 2020. The agency (USFDA) stated that ‘it is reasonable to believe that bamlanivimab may be effective for the treatment of mild to moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 y of age and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization, and that when used under the conditions described in this authorization, the known and potential benefits of bamlanivimab when used to treat COVID-19 in such patients outweigh the known and potential risks of such product’ [129].
Evidence-based approach to early outpatient treatment of SARS-CoV-2 (COVID-19) infection
Published in Baylor University Medical Center Proceedings, 2021
J. Drew Payne, Kimberly Sims, Cynthia Peacock, Tanis Welch, Ruth E. Berggren
Monoclonal antibodies should be given within 10 days of symptom onset to COVID-19–positive patients at high risk for disease progression. The criteria for utilization, logistical difficulty, and limited supply restrict this intervention’s possible impact. However, with a number needed to treat of approximately 16 to 20, these medications may well reduce hospitalizations and lower the strain on medical facilities in areas that need relief.6,7 The Infectious Diseases Society of America has recommended against routine use of bamlanivimab or casirivimab/imdevimab, but has suggested the use of bamlanivimab and etesevimab based on an interim analysis of the BLAZE-1 clinical trial, which announced via press release a 70% risk reduction of hospitalization or death (P = 0.0004).8 The National Institutes of Health (NIH) recommends either bamlanivimab/etesevimab or casirivimab/imdevimab, yet recommends against bamlanivimab monotherapy.4