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

• Published in: The Journal of infectious diseases 2023-01, Vol.227 (2), p.226-235
• Main Authors: Shehadeh, Fadi, Benitez, Gregorio, Mylona, Evangelia K, Tran, Quynh-Lam, Tsikala-Vafea, Maria, Atalla, Eleftheria, Kaczynski, Matthew, Mylonakis, Eleftherios
• Format: Article
• Language: English
• Subjects: COVID-19 - complications; Humans; Hypoxia - drug therapy; Hypoxia - therapy; Lymphopenia; Oxygen; Pilot Projects; Prospective Studies; Thymalfasin - therapeutic use; Thymosin - therapeutic use
• ISSN: 0022-1899; 1537-6613
• DOI: 10.1093/infdis/jiac362

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. 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.