A Pilot Trial of Thymalfasin (Thymosin-α-1) to Treat Hospitalized Patients With Hypoxemia and Lymphocytopenia Due to Coronavirus Disease 2019 Infection
| Autor: | Fadi Shehadeh, Gregorio Benitez, Evangelia K Mylona, Quynh-Lam Tran, Maria Tsikala-Vafea, Eleftheria Atalla, Matthew Kaczynski, Eleftherios Mylonakis |
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| Rok vydání: | 2022 |
| Předmět: | |
| Zdroj: | The Journal of Infectious Diseases. 227:226-235 |
| ISSN: | 1537-6613 0022-1899 |
| DOI: | 10.1093/infdis/jiac362 |
| Popis: | Background Thymosin-α-1 (Tα1) may be a treatment option for coronavirus disease 2019 (COVID-19), but efficacy and safety data remain limited. Methods Prospective, open-label, randomized trial assessing preliminary efficacy and safety of thymalfasin (synthetic form of Tα1), compared with the standard of care, among hospitalized patients with hypoxemia and lymphocytopenia due to COVID-19. Results A total of 49 patients were included in this analysis. Compared with control patients, the incidence of clinical recovery was higher for treated patients with either baseline low-flow oxygen (subdistribution hazard ratio, 1.48 [95% confidence interval, .68–3.25]) or baseline high-flow oxygen (1.28 [.35–4.63]), although neither difference was significant. Among patients with baseline low-flow oxygen, treated patients, compared with control patients, had an average difference of 3.84 times more CD4+ T cells on day 5 than on day 1 (P = .01). Nine serious adverse events among treated patients were deemed not related to Tα1. Conclusions Tα1 increases CD4+ T-cell count among patients with baseline low-flow oxygen support faster than the standard of care and may have a role in the management of hospitalized patients with hypoxemia and lymphocytopenia due to COVID-19. Clinical Trials Registration NCT04487444. |
| Databáze: | OpenAIRE |
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