Randomized controlled trial of pirfenidone XR for patients with COVID-19 and exploration of effects on long-COVID incidence.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
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M Tamez-Torres Karla, Karina Aguilar Laura, Alejandro Díaz-Mejía Bruno, Maria de la Luz Morales-Ortega, E Ramírez-González Luis, Ren Highstrete, S González-Cruz Adalberto, Esteban Pérez-García, Vanessa Hernández-Martínez Ingrid, Alejandra Hernández-Delgado, Nadiel Hernández-Aldana, A Gorgonio Pedro, A Núñez-Álvarez Carlos, F Hernández-Ramírez Diego, A Lara-García Eunice, Alfonso Rumoroso-García Jose, Angelica Nava-Linares, Axel Cervantes-Sánchez, Mónica Chapa-Ibargüengoitia, R Valdez-Vazquez Rafael, Alfredo Ponce-de León, Estuardo Aguilar-Cordova, K Aguilar Laura, David Kershenobich-Stalnikowitz, Jose Sifuentes-Osornio
Аннотация
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.