Safety and Effectiveness of Regdanvimab for COVID-19 Treatment: A Phase 4 Post-marketing Surveillance Study Conducted in South Korea DOI Creative Commons
Ji Yeon Lee, Seon Hee Bu, Eun-Hyang Song

et al.

Infectious Diseases and Therapy, Journal Year: 2023, Volume and Issue: 12(10), P. 2417 - 2435

Published: Oct. 1, 2023

Regdanvimab, a neutralising monoclonal antibody (mAb) against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), received approval for the treatment of disease 2019 (COVID-19) in South Korea 2021. The Ministry Food and Drug Safety mandate that new medications be re-examined safety effectiveness post-approval at least 3000 individuals. This post-marketing surveillance (PMS) study was used to evaluate regdanvimab real-world clinical care. prospective, multicentre, phase 4 PMS conducted between February 2021 March 2022 Korea. Eligible patients were aged ≥ 18 years with confirmed mild COVID-19 high risk progression or moderate COVID-19. Patients hospitalised treated (40 mg/kg, day 1) then monitored until discharge, follow-up call on 28. Adverse events (AEs) documented, rate measure effectiveness. Of 3123 infection identified, 3036 eligible inclusion. Approximately 80% 5% diagnosed during delta- omicron-dominant periods, respectively. Median (range) age 57 (18–95) years, 50.6% male. severity assessed before treatment, high-risk 1030 (33.9%) 2006 (66.1%) patients, AEs adverse drug reactions (ADRs) experienced by 684 (22.5%) 363 (12.0%) most common ADR increased liver function test (n = 62, 2.0%). Nine (0.3%) discontinued due ADRs. Overall, 378 (12.5%) after infusion, extended hospitalisation/re-admission 300, 9.9%) as reason. Supplemental oxygen required 282 (9.3%) patients. Ten intensive care monitoring 3 (0.1%) died large-scale demonstrated effective had an acceptable profile when practice.

Language: Английский

In silico evaluation of ten monoclonal antibodies neutralization power of SARS-CoV-2 variants EG.5 and BA.2.86 DOI Open Access
Dana Ashoor, M. Dahmani Fathallah

Published: Dec. 14, 2023

The current globally dominant SARS-CoV-2 variants are showing immune escape and reduced susceptibility to antiviral drugs. Therefore, agencies responsible for drug evaluation regula-tion such as the FDA EMA revising their emergency authorization use of several COVID-19 neutralizing antibodies. These NAbs proved be unlikely effective against new espe-cially Omicron descendants pharmaceutical companies pursuing development more potent To address issue using in silico prediction rapid assessment anti-SARS-CoV-2 MAbs neutralization power, we used a computational method developed previously, evaluate 10 antibodies propensity neutralize Omicron’s subvariants Eris (EG.5) Pirola (BA.2.86) based on comparative binding affinity previous experimental clinical observations. Nine these were once granted authorization, one is currently under investigation. rapid, cost-effective provided reliable predictions consistent with published data. Furthermore, our data showed potential therapeutic combi-nation that could treatment countermeasure (BA.2.86).

Language: Английский

Citations

1
Safety and Effectiveness of Regdanvimab for COVID-19 Treatment: A Phase 4 Post-marketing Surveillance Study Conducted in South Korea DOI Creative Commons
Ji Yeon Lee, Seon Hee Bu, Eun-Hyang Song

et al.

Infectious Diseases and Therapy, Journal Year: 2023, Volume and Issue: 12(10), P. 2417 - 2435

Published: Oct. 1, 2023

Regdanvimab, a neutralising monoclonal antibody (mAb) against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), received approval for the treatment of disease 2019 (COVID-19) in South Korea 2021. The Ministry Food and Drug Safety mandate that new medications be re-examined safety effectiveness post-approval at least 3000 individuals. This post-marketing surveillance (PMS) study was used to evaluate regdanvimab real-world clinical care. prospective, multicentre, phase 4 PMS conducted between February 2021 March 2022 Korea. Eligible patients were aged ≥ 18 years with confirmed mild COVID-19 high risk progression or moderate COVID-19. Patients hospitalised treated (40 mg/kg, day 1) then monitored until discharge, follow-up call on 28. Adverse events (AEs) documented, rate measure effectiveness. Of 3123 infection identified, 3036 eligible inclusion. Approximately 80% 5% diagnosed during delta- omicron-dominant periods, respectively. Median (range) age 57 (18–95) years, 50.6% male. severity assessed before treatment, high-risk 1030 (33.9%) 2006 (66.1%) patients, AEs adverse drug reactions (ADRs) experienced by 684 (22.5%) 363 (12.0%) most common ADR increased liver function test (n = 62, 2.0%). Nine (0.3%) discontinued due ADRs. Overall, 378 (12.5%) after infusion, extended hospitalisation/re-admission 300, 9.9%) as reason. Supplemental oxygen required 282 (9.3%) patients. Ten intensive care monitoring 3 (0.1%) died large-scale demonstrated effective had an acceptable profile when practice.

Language: Английский

Citations

0