A large multicenter study of over 2,200 COVID-19 patients in China found that thymosin alpha-1 treatment was associated with worse outcomes, not better. Patients who received the drug had higher rates of non-recovery, death, intubation, and kidney injury compared to those who did not, even after accounting for disease severity differences. The risk was particularly elevated in patients who were already critically ill or who started the treatment later in their illness.
Abstract
BACKGROUND: Thymosin alpha 1 (Tα1) is widely used to treat patients with COVID-19 in China; however, its efficacy remains unclear. This study aimed to explore the efficacy of Tα1 as a COVID-19 therapy.
METHODS: We performed a multicenter cohort study in five tertiary hospitals in the Hubei province of China between December 2019 and March 2020. The patient non-recovery rate was used as the primary outcome.
RESULTS: All crude outcomes, including non-recovery rate (65/306290/1,976,= 0.003), in-hospital mortality rate (62/306271/1,976,= 0.003), intubation rate (31/306106/1,976,= 0.001), acute respiratory distress syndrome (ARDS) incidence (104/306499/1,976,= 0.001), acute kidney injury (AKI) incidence (26/30666/1,976,< 0.001), and length of intensive care unit (ICU) stay (14.9 ± 12.78.7 ± 8.2 days,< 0.001), were significantly higher in the Tα1 treatment group. After adjusting for confounding factors, Tα1 use was found to be significantly associated with a higher non-recovery rate than non-Tα1 use (OR 1.5, 95% CI 1.1-2.1,= 0.028). An increased risk of non-recovery rate associated with Tα1 use was observed in the patient subgroups with maximum sequential organ failure assessment (SOFA) scores ≥2 (OR 2.0, 95%CI 1.4-2.9,= 0.024), a record of ICU admission (OR 5.4, 95%CI 2.1-14.0,< 0.001), and lower PaO2/FiO2 values (OR 1.9, 95%CI 1.1-3.4,= 0.046). Furthermore, later initiation of Tα1 use was associated with a higher non-recovery rate.
CONCLUSION: Tα1 use in COVID-19 patients was associated with an increased non-recovery rate, especially in those with greater disease severity.