NCT04282902 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Dewage SNV, Organ L, Koumoundouros E, Derseh HB, Perera KUE, Samuel CS, Stent AW, Snibson KJ
The efficacy of pirfenidone in a sheep model of pulmonary fibrosis. Exp Lung Res. 2019 Nov - Dec;45(9-10):310-322. doi: 10.1080/01902148.2019.1695019. Epub 2019
Epstein Shochet G, Wollin L, Shitrit D
Fibroblast-matrix interplay: Nintedanib and pirfenidone modulate the effect of IPF fibroblast-conditioned matrix on normal fibroblast phenotype. Respirology. 2018 Aug;23(8):756-763. doi: 10.1111/resp.13287. Epub 201
Ikeda S, Sekine A, Baba T, Katano T, Tabata E, Shintani R, Sadoyama S, Yamakawa H, Oda T, Okuda R, Kitamura H, Iwasawa T, Takemura T, Ogura T
Negative impact of anorexia and weight loss during prior pirfenidone administration on subsequent nintedanib tre
Lehmann M, Buhl L, Alsafadi HN, Klee S, Hermann S, Mutze K, Ota C, Lindner M, Behr J, Hilgendorff A, Wagner DE, Königshoff M
Differential effects of Nintedanib and Pirfenidone on lung alveolar epithelial cell function in ex vivo murine and human lung tis

A Randomized, Open-label Study to Evaluate the Efficacy and Safety of Pirfenidone in Patients With Severe and Critical Novel Coronavirus Infection

Clinical trial NCT04282902 - References