Authors
Tamez-Torres Karla M, Aguilar Laura Karina, Díaz-Mejía Bruno Alejandro, Morales-Ortega Maria de la Luz, Ramírez-González Luis E, Highstrete Ren, González-Cruz Adalberto S, Pérez-García Esteban, Hernández-Martínez Ingrid Vanessa, Hernández-Delgado Alejandra, Hernández-Aldana Nadiel, Gorgonio Pedro A, Núñez-Álvarez Carlos A, Hernández-Ramírez Diego F, Lara-García Eunice A, Rumoroso-García Jose Alfonso, Nava-Linares Angelica, Cervantes-Sánchez Axel, Chapa-Ibargüengoitia Mónica, Valdez-Vazquez Rafael R, Ponce-de León Alfredo, Aguilar-Cordova Estuardo, Aguilar Laura K, Kershenobich-Stalnikowitz David, Sifuentes-Osornio Jose
Published in
International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases. Pages 109186. Oct 19, 2026. Epub Oct 19, 2026.
Abstract
Evaluate safety and efficacy of extended-release pirfenidone (pirfenidone-XR), an anti-inflammatory and anti-fibrotic agent, as an early treatment for acute and long-term effects of COVID-19.
This double-blinded, placebo-controlled trial randomized hospitalized and ambulatory COVID-19 patients in Mexico City 2:1 to pirfenidone-XR or placebo. The primary endpoint was recovery dynamics using a clinical severity 7-point ordinal scale; secondary and exploratory endpoints included long COVID incidence and safety. Planned enrollment was 801 patients to detect a 50% relative-risk reduction in key clinical outcomes.
Between May 2020 and May 2021, 367 patients were enrolled, approximately 50% of the target. Evolving standards of care resulted in early termination and lower-than-anticipated event rates, limiting statistical power. Time-to-recovery analyses suggested improved dynamics with pirfenidone-XR: both groups had 53% full recovery by week 1; an additional 33% vs 21% achieved it during week 2, and 97% vs 90% by week 4. Long-term follow-up showed a numerically lower incidence of long COVID symptoms in 1, 2, 3 and 4 symptom domains in the pirfenidone-XR group: symptoms in ≥4 domains were reported in 5% vs 21% of hospitalized patients. There were no unexpected safety signals.
Pirfenidone-XR was well tolerated and, although underpowered, demonstrated numerical trends of improved recovery and reduced long COVID risk. These findings support further investigation of pirfenidone-XR in patients infected with SARS-CoV-2 and similar post-infectious syndromes characterized by persistent immune activation and tissue remodeling.
PMID:
42896728
Bibliographic data and abstract were imported from PubMed on 20 Oct 2026.
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