A nonrandomized phase 2 trial of oral thymic peptides in hospitalized patients with Covid-19
Authors: Ramos-Zaldívar Héctor M. , Reyes-Perdomo Karla G. , Espinoza-Moreno Nelson A. , Dox-Cruz Ernesto Tomás , Aguirre Urbina Thania Camila , Rivera Caballero Astrid Yohaly , Perdomo Dominguez Eduardo Smelin , Peña Calix Sofía Guadalupe , Monterroso-Reyes Joselin Michelle , Caballero Vásquez Erick Fernando , Zelaya Ortiz Tarek Sai , Rodríguez-Machado Hilbron Eduardo , Forgas Solis Marcelo Andres , Silva Iveth Sebilla , Zavala Galeano Mauricio Edgardo , Morga Alvarado Alejandro Antonio , Solís Medina Angie María Nicolle , Guerrero-Díaz Leticia M. , Jiménez-Faraj Julia E. , Perelló Santos Caroll Alejandra , Moncada Arita Wilberg A. , Valdiviezo Montufar Darwing Fabricio , Hernández Sabillón Josué David , Sorto G. Mónica L. , Padilla Navarro Xochilt Xiomara , Palomo-Bermúdez Victoria A. , Alvarenga Andino Héctor Armando , Reyes Guzman Sandra Patricia , Rivera Reyes María Haydee , Medina Paz Esdras Said , Alvarado Enamorado Joselyn Rosario , Sabillón Sagastume Yenny Mariel , Mejia Rivera Ariadna Stephanny , Posas Sarmiento Claudia Michelle , Jiménez Pineda Xenia Vanessa , Hernández Puerto Verónica Alejandra , Portillo Landaverde Josué David , Sergio Reyes S. , Perdomo R. Ivin , Rivera Josué J. , Mendoza Girón Wendy Cecilia , Tróchez Sabillón Karla Melissa , Katsumata Leiva Paola Nohemy , Pineda Toro Karla Elizabeth , Montes-Gambarelli Jimena A. , Flores Cristhiam , Salas-Huenuleo Edison , Andia Marcelo E. 
Published: December 2021

Background

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.

Methods

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.

Results

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.

Conclusion

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.

Trial registration

ClinicalTrials.govNCT04771013. February 25, 2021.