A nonrandomized phase 2 trial of oral thymic peptides in hospitalized patients with Covid-19

  1. Héctor M. Ramos-Zaldívar
  2. Karla G. Reyes-Perdomo
  3. Nelson A. Espinoza-Moreno
  4. Ernesto Tomás Dox-Cruz
  5. Thania Camila Aguirre Urbina
  6. Astrid Yohaly Rivera Caballero
  7. Eduardo Smelin Perdomo Dominguez
  8. Sofía Guadalupe Peña Calix
  9. Joselin Michelle Monterroso-Reyes
  10. Erick Fernando Caballero Vásquez
  11. Tarek Sai Zelaya Ortiz
  12. Hilbron Eduardo Rodríguez-Machado
  13. Marcelo Andres Forgas Solis
  14. Iveth Sebilla Silva
  15. Mauricio Edgardo Zavala Galeano
  16. Alejandro Antonio Morga Alvarado
  17. Angie María Nicolle Solís Medina
  18. Leticia M. Guerrero-Díaz
  19. Julia E. Jiménez-Faraj
  20. Caroll Alejandra Perelló Santos
  21. Wilberg A. Moncada Arita
  22. Darwing Fabricio Valdiviezo Montufar
  23. Josué David Hernández Sabillón
  24. Mónica L. Sorto G.
  25. Xochilt Xiomara Padilla Navarro
  26. Victoria A. Palomo-Bermúdez
  27. Héctor Armando Alvarenga Andino
  28. Sandra Patricia Reyes Guzman
  29. María Haydee Rivera Reyes
  30. Esdras Said Medina Paz
  31. Joselyn Rosario Alvarado Enamorado
  32. Yenny Mariel Sabillón Sagastume
  33. Ariadna Stephanny Mejia Rivera
  34. Claudia Michelle Posas Sarmiento
  35. Xenia Vanessa Jiménez Pineda
  36. Verónica Alejandra Hernández Puerto
  37. Josué David Portillo Landaverde
  38. Reyes S. Sergio
  39. Ivin Perdomo R.
  40. Josué J. Rivera
  41. Wendy Cecilia Mendoza Girón
  42. Karla Melissa Tróchez Sabillón
  43. Paola Nohemy Katsumata Leiva
  44. Karla Elizabeth Pineda Toro
  45. Jimena A. Montes-Gambarelli
  46. Cristhiam Flores
  47. Edison Salas-Huenuleo
  48. Marcelo E. Andia
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Abstract

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

<ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://ClinicalTrials.gov">ClinicalTrials.gov</ext-link> <ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT04771013">NCT04771013</ext-link> . February 25, 2021.

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