A nonrandomized phase 2 trial of oral thymic peptides in hospitalized patients with Covid-19
In this small nonrandomized trial, thymic peptides showed no deaths and a shorter recovery time in hospitalized Covid-19 patients compared to standard care, but the findings should be interpreted with caution due to study limitations.
Where it sits
this study against the rest of the thymulin (facteur thymique serique) corpusSummary and findings
This study evaluated the safety and efficacy of a daily 250-mg oral dose of thymic peptides in hospitalized Covid-19 patients. A total of 44 patients were analyzed, with 22 receiving thymic peptides and 22 receiving standard care. The intervention group reported no deaths, while the standard care group had a 24% mortality rate by day 20.
Abstract
<h4>Background</h4> Coronavirus disease 2019 (Covid-19) active cases continue to demand the development of safe and effective treatments. This is the first clinical trial to evaluate the safety and efficacy of oral thymic peptides. <h4>Methods</h4> We conducted a nonrandomized phase 2 trial with a historic control group to evaluate the safety and efficacy of a daily 250-mg oral dose of thymic peptides in the treatment of hospitalized Covid-19 patients. Comparison based on standard care from registry data was performed after propensity score matching. The primary outcomes were survival, time to recovery and the number of participants with treatment-related adverse events or side effects by day 20. <h4>Results</h4> A total of 44 patients were analyzed in this study, 22 in the thymic peptides group and 22 in the standard care group. There were no deaths in the intervention group, compared to 24% mortality in standard care by day 20 (log-rank P=0.02). The Kaplan-Meier analysis showed a significantly shorter time to recovery by day 20 in the thymic peptides group as compared with standard care (median, 6 days vs. 12 days; hazard ratio for recovery, 2.75 [95% confidence interval, 1.34 to 5.62]; log-rank P=0.002). No side effects or adverse events were reported. <h4>Conclusion</h4> In patients hospitalized with Covid-19, the use of thymic peptides reported no side effects, adverse events, or deaths by day 20. When compared with registry data, a significantly shorter time to recovery and mortality reduction was measured. The Catholic University of Honduras Medical Research Group (GIMUNICAH) is working on a more extensive phase 3 trial. <h4>Trial registration</h4> ClinicalTrials.gov NCT04771013 . February 25, 2021.