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| http://dx.doi.org/10.1016/S1473-3099(22)00693-4 | DOI Listing |
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SARS-COV-2 Pre-Exposure Prophylaxis With Tixagevimab-Cilgavimab in Haematological, Immunocompromised Patients in the Omicron Era.
Eur J Haematol
January 2025
Department of Haematology, Oncology, Immunology, Palliative Medicine, Infectious Diseases and Tropical Medicine, Muenchen Klinik Schwabing, Munich, Germany.
Article Synopsis
- Tixagevimab-cilgavimab is effective in reducing severe COVID-19 outcomes in high-risk hematological malignancy patients during the Omicron wave, despite a significant incidence of breakthrough infections.
- 32.6% of patients experienced COVID-19 infections, but most cases were milder and shorter in duration, especially within the first six months of treatment.
- Recent B-cell depletion was identified as a significant risk factor for breakthrough infections, indicating that these patients may need extra caution and monitoring.
Immunogenicity and safety of tixagevimab-cilgavimab for COVID-19 pre-exposure prophylaxis in immunocompromised 20 to <40 kg children and adolescents: A pilot, prospective, open-labeled study.
Hum Vaccin Immunother
December 2024
Division of Infectious Diseases, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
Article Synopsis
- A study was conducted to assess the effectiveness of Tixagevimab-Cilgavimab in immunocompromised children and adolescents weighing between 20 to >40 kg, with two different dosage groups based on weight (300 mg for 20 to <40 kg and 600 mg for ≥40 kg).
- After measuring antibody levels at multiple time points, results showed that both dosages produced high levels of neutralizing antibodies against the ancestral SARS-CoV-2 strain, significantly surpassing levels in healthy children who had received three BNT162b2 vaccinations.
- Adverse effects were mild and slightly more common in the heavier dosage group; overall, the study concluded that the lower dosage was just as effective as the higher
Cilgavimab and tixagevimab as pre-exposure prophylaxis in vaccine non-responder kidney transplant recipients during a period of prevalent SARS-CoV-2 BA.2 and BA.4/5 variants-a prospective cohort study (RESCUE-TX).
EBioMedicine
November 2024
Division of Nephrology and Dialysis, Department of Medicine III, Medical University of Vienna, Vienna, Austria. Electronic address:
Background: The response to severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) vaccination is severely impaired in patients on maintenance immunosuppression after kidney transplantation.
Methods: We conducted a prospective cohort study of 194 kidney transplant recipients (KTR) who exhibited no response to SARS-CoV-2 vaccinations (i.e.
Adverse events associated with SARS-CoV-2 neutralizing monoclonal antibodies using the FDA adverse event reporting system database.
Toxicol Res
October 2024
Research Institute of Pharmaceutical Sciences, College of Pharmacy, Chosun University, 309 Pilmun-Daero, Dong-gu, Gwangju, 61452 Republic of Korea.
The purpose of this study was to analyze the important medical events (IMEs) of anti-severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) monoclonal antibodies using the reports from the United States Food and Drug Administration (US FDA) adverse event reporting system (FAERS) and to detect safety signals. In this study, data from the FAERS from January 2020 to December 2022 were used to investigate signals associated with five monoclonal antibody products (bamlanivimab, bamlanivimab/etesevimab, bebtelovimab, casirivimab/imdevimab, sotrovimab) in coronavirus disease 2019 (COVID-19) patients and one monoclonal antibody product (tixagevimab/cilgavimab) in patients wherein COVID-19 vaccination was not recommended. Disproportionality analyses were conducted using the reporting odds ratio, and an information component to identify safety signals.
View Article and Find Full Text PDFPooled analysis of the MANTICO2 and MONET randomized controlled trials comparing drug efficacy for early treatment of COVID-19 during Omicron waves.
J Infect
November 2024
Infectious Diseases Division, Department of Diagnostics and Public Health, University of Verona, Verona, Italy.
Background: The clinical effectiveness of early therapies for mild-to-moderate COVID-19, comparing antivirals and monoclonal antibodies (mAbs) during the Omicron era, has not been conclusively assessed through a post-approval comparative trial. We present a pooled analysis of two randomized clinical trials conducted during Omicron waves.
Methods: The MANTICO2/MONET trial is a pooled analysis of two multicentric, independent, phase-4, three-arm, superiority, randomized, open-label trials.
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