A Pilot Trial of Thymalfasin (Thymosin-α-1) to Treat Hospitalized Patients With Hypoxemia and Lymphocytopenia Due to Coronavirus Disease 2019 Infection. (3rd September 2022)

• Record Type: Journal Article
• Authors: Shehadeh, Fadi; Benitez, Gregorio; Mylona, Evangelia K; Tran, Quynh-Lam; Tsikala-Vafea, Maria; Atalla, Eleftheria; Kaczynski, Matthew; Mylonakis, Eleftherios
• Is Part Of: Journal of infectious diseases. Volume 227:Number 2(2023)
• Page Start: 226
• Page End: 235
• Publication Date: 2022-09-03
• Subjects: COVID-19 -- efficacy -- hypoxemia -- lymphocytopenia -- lymphopenia -- safety -- thymalfasin -- thymosin-α-1; Communicable diseases -- Periodicals; Diseases -- Causes and theories of causation -- Periodicals; Medicine -- Periodicals; Communicable Diseases -- Periodicals; Electronic journals; 616.9
• DOI: 10.1093/infdis/jiac362
• Languages: English
• ISSNs: 0022-1899

Abstract

Abstract: 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. Abstract : Lymphocytopenia due to coronavirus disease 2019 (COVID-19) is associated with poor clinical outcomes. Thymosin-α-1 (Tα1) promotes T-cell maturation and modulates cytokine signaling. We found that Tα1 is safe, may increase CD4 + T-cell count, and merits further study in managing COVID-19.