drugset / Trial / NCT06585319
Pirfenidone LP or Collagen-polyvinylpyrrolidone in COVID-19
RandomizedParallel-groupSingle-blindTreatment
Summary
Collagen-polyvinylpyrrolidone (collagen-PVP) and pirfenidone have the ability to control cytokine storms. This work explores the therapeutic effects of both, on the early treatment of patients with severe COVID-19. The hospital stay, quick COVID-19 severity index (qCSI) and admission to the ICU were statistically significantly lower when the patients were treated with collagen-PVP or pirfenidone, compared to the controls treated with dexamethasone alone.
Timeline
- Start
- 2020-02-01
- Primary completion
- 2021-06-30
- Completion
- 2024-08-31
Publications
- Background Leyva-Gomez G, Lima E, Krotzsch G, Pacheco-Marin R, Rodriguez-Fuentes N, Quintanar-Guerrero D, Krotzsch E. Physicochemical and functional characterization of the collagen-polyvinylpyrrolidone copolymer. J Phys Chem B. 2014 Aug 7;118(31):9272-83. doi: 10.1021/jp502476x. Epub 2014 Jul 30.
- Background Olmos-Zuniga JR, Silva-Martinez M, Jasso-Victoria R, Baltazares-Lipp M, Hernandez-Jimenez C, Buendia-Roldan I, Jasso-Arenas J, Martinez-Salas A, Calyeca-Gomez J, Guzman-Cedillo AE, Gaxiola-Gaxiola M, Romero-Romero L. Effects of Pirfenidone and Collagen-Polyvinylpyrrolidone on Macroscopic and Microscopic Changes, TGF-beta1 Expression, and Collagen Deposition in an Experimental Model of Tracheal Wound Healing. Biomed Res Int. 2017;2017:6471071. doi: 10.1155/2017/6471071. Epub 2017 May 11.
- Background Furuzawa-Carballeda J, Cabral AR, Zapata-Zuniga M, Alcocer-Varela J. Subcutaneous administration of polymerized-type I collagen for the treatment of patients with rheumatoid arthritis. An open-label pilot trial. J Rheumatol. 2003 Feb;30(2):256-9.
- Background Kinross P, Suetens C, Dias JG, Alexakis L, Wijermans A, Colzani E, Monnet DL; European Centre for Disease Prevention and Control (ECDC) Public Health Emergency Team; ECDC Public Health Emergency Team. Rapidly increasing cumulative incidence of coronavirus disease (COVID-19) in the European Union/European Economic Area and the United Kingdom, 1 January to 15 March 2020. Euro Surveill. 2020 Mar;25(11):2000285. doi: 10.2807/1560-7917.ES.2020.25.11.2000285. Epub 2020 Mar 16.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Collagen-Polyvinylpyrrolidone | Protein / enzyme biologic | 2 ml | Intramuscular |
| Comparator | Pirfenidone | Small molecule | 1200 mg | Oral |