Thymosin alpha-1 · research summary

A Pilot Trial of Thymalfasin (Thymosin-α-1) to Treat Hospitalized Patients With Hypoxemia and Lymphocytopenia Due to Coronavirus Disease 2019 Infection.

The Journal of infectious diseases · 2023. Summary drawn from the study's full text. Each statement is followed by the exact sentence it comes from. This is a research summary, not medical advice.

Study type

Prospective, open-label, randomized pilot trial
“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.”

Subjects

Hospitalized patients with hypoxemia and lymphocytopenia due to Coronavirus Disease 2019 infection
“A total of 49 patients were included in this analysis.”

Sample size

49 patients
“A total of 49 patients were included in this analysis.”

Reported findings

Treated patients had a higher incidence of clinical recovery compared to controls, though differences were not statistically significant
“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 had a significantly greater increase in CD4+ T cells on day 5 compared to day 1 than control patients
“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 in treated patients were deemed not related to Thymalfasin
“Nine serious adverse events among treated patients were deemed not related to Tα1.”

Limitations stated by the authors

Efficacy and safety data remain limited
“Thymosin-α-1 (Tα1) may be a treatment option for coronavirus disease 2019 (COVID-19), but efficacy and safety data remain limited.”

Source: PubMed 36056913 · DOI 10.1093/infdis/jiac362 · all study summaries

Reported findings

Treated patients had a higher incidence of clinical recovery compared to controls, though differences were not statistically significant

“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 had a significantly greater increase in CD4+ T cells on day 5 compared to day 1 than control patients

“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 in treated patients were deemed not related to Thymalfasin

“Nine serious adverse events among treated patients were deemed not related to Tα1.”