TY - JOUR
T1 - A Pilot Trial of Thymalfasin (Thymosin-α-1) to Treat Hospitalized Patients With Hypoxemia and Lymphocytopenia Due to Coronavirus Disease 2019 Infection
AU - Shehadeh, Fadi
AU - Benitez, Gregorio
AU - Mylona, Evangelia K.
AU - Tran, Quynh Lam
AU - Tsikala-Vafea, Maria
AU - Atalla, Eleftheria
AU - Kaczynski, Matthew
AU - Mylonakis, Eleftherios
N1 - © 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: [email protected].
PY - 2023/1/15
Y1 - 2023/1/15
N2 - 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.
AB - 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.
KW - COVID-19
KW - efficacy
KW - hypoxemia
KW - lymphocytopenia
KW - lymphopenia
KW - safety
KW - thymalfasin
KW - thymosin-α-1
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U2 - 10.1093/infdis/jiac362
DO - 10.1093/infdis/jiac362
M3 - Article
C2 - 36056913
AN - SCOPUS:85144437210
SN - 0022-1899
VL - 227
SP - 226
EP - 235
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
IS - 2
ER -