Background. Thymosin-alpha-1 (T alpha 1) 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 T alpha 1), 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 T alpha 1. Conclusions. T alpha 1 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.
[1]Brown Univ, Warren Alpert Med Sch, Infect Dis Div, Providence, RI USA.
[2]Natl Tech Univ Athens, Sch Elect & Comp Engn, Athens, Greece.
[3]Brown Univ, Warren Alpert Med Sch, Infect Dis Div, 593 Eddy St Phys Off Bldg Third Floor Ste 328 330, Providence, RI 02903 USA.
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