Study summary · research use only
A Pilot Trial of Thymalfasin (Thymosin-α-1) to Treat Hospitalized Patients With Hypoxemia and Lymphocytopenia Due to Coronavirus Disease 2019 Infection
Plain-language summary
Paraphrased from the published abstract below — not a verdict on whether anything works.
This prospective, open-label, randomized trial in hospitalized humans with hypoxemia and lymphocytopenia due to COVID-19 compared thymalfasin (synthetic thymosin-α-1) to standard of care. A total of 49 patients were included. Among patients with baseline low-flow oxygen, treated patients had 3.84 times more CD4+ T cells on day 5 than on day 1 (P = .01) versus standard of care; the incidence of clinical recovery was numerically higher for treated patients at both low-flow and high-flow baseline oxygen, though neither difference reached statistical significance. Nine serious adverse events occurred among treated patients and were judged unrelated to thymosin-α-1. The authors describe thymosin-α-1 as raising CD4+ T-cell counts faster than standard care in this subgroup and suggest a possible role in managing such patients.
Abstract
Thymosin-α-1 (Tα1) may be a treatment option for coronavirus disease 2019 (COVID-19), but efficacy and safety data remain limited. 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. 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. 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. NCT04487444.
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