A Pilot Trial of Thymalfasin (Thymosin-α-1) to Treat Hospitalized Patients With Hypoxemia and Lymphocytopenia Due to Coronavirus Disease 2019 Infection
Fadi Shehadeh, Gregorio Benitez, Evangelia K Mylona, Quynh-Lam Tran, Maria Tsikala-Vafea, Eleftheria Atalla, Matthew Kaczynski, Eleftherios Mylonakis, Fadi Shehadeh, Gregorio Benitez, Evangelia K Mylona, Quynh-Lam Tran, Maria Tsikala-Vafea, Eleftheria Atalla, Matthew Kaczynski, Eleftherios Mylonakis
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.
Keywords: COVID-19; efficacy; hypoxemia; lymphocytopenia; lymphopenia; safety; thymalfasin; thymosin-α-1.
Conflict of interest statement
Potential conflicts of interest. All authors: No reported conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.
© The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
Source: PubMed