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A Pilot Trial of Thymalfasin (Tα1) to Treat Hospitalized Patients with Hypoxemia and Lymphocytopenia due to COVID-19 Infection.
Shehadeh, Fadi; Benitez, Gregorio; Mylona, Evangelia K; Tran, Quynh Lam; Tsikala-Vafea, Maria; Atalla, Eleftheria; Kaczynski, Matthew; Mylonakis, Eleftherios.
  • Shehadeh F; Infectious Diseases Division, Warren Alpert Medical School of Brown University, Providence, RI, USA.
  • Benitez G; School of Electrical and Computer Engineering, National Technical University of Athens, Athens, Greece.
  • Mylona EK; Infectious Diseases Division, Warren Alpert Medical School of Brown University, Providence, RI, USA.
  • Tran QL; Infectious Diseases Division, Warren Alpert Medical School of Brown University, Providence, RI, USA.
  • Tsikala-Vafea M; Infectious Diseases Division, Warren Alpert Medical School of Brown University, Providence, RI, USA.
  • Atalla E; Infectious Diseases Division, Warren Alpert Medical School of Brown University, Providence, RI, USA.
  • Kaczynski M; Jacobi Medical Center, Albert Einstein College of Medicine, Bronx, NY, USA.
  • Mylonakis E; Infectious Diseases Division, Warren Alpert Medical School of Brown University, Providence, RI, USA.
J Infect Dis ; 2022 Sep 03.
Article in English | MEDLINE | ID: covidwho-2235518
ABSTRACT

BACKGROUND:

Thymosin-α-1 (Tα1) may be a treatment option for 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 standard of care, among hospitalized patients with hypoxemia and lymphocytopenia due to COVID-19.

RESULTS:

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 [SHR] 1.48; 95% CI 0.68-3.25) or baseline high flow oxygen (SHR 1.28; 95% CI 0.35-4.63), although neither were 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 = 0.0113). Nine serious adverse events among treated patients were deemed not related to Tα1.

CONCLUSION:

Tα1 increases CD4+ T cell count among patients with baseline low flow oxygen support faster than standard of care and may have a role in the management of hospitalized patients with hypoxemia and lymphocytopenia due to COVID-19.
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Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Language: English Year: 2022 Document Type: Article Affiliation country: Infdis

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Language: English Year: 2022 Document Type: Article Affiliation country: Infdis