NCT04607928: FIBRO-COVID

Pirfenidone Compared to Placebo in Post-COVID19 Pulmonary Fibrosis COVID-19

Status unknown Phase 2 Last updated 30 December 2021

What this trial tests

Phase 2 trial testing Pirfenidone in Fibrotic Pulmonary Sequelae Post-COVID19 Infection in 148 participants. Status unknown.

Timeline

1 August 2020

Primary endpoint
30 January 2022

30 June 2022

Quick facts

Lead sponsor	Institut d'Investigació Biomèdica de Bellvitge
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	148
Start date	1 August 2020
Primary completion	30 January 2022
Estimated completion	30 June 2022
Sites	8 locations across Spain

Drugs / interventions tested

• Pirfenidone — full drug profile →
• Placebo

Conditions studied

• Fibrotic Pulmonary Sequelae Post-COVID19 Infection — all drugs for Fibrotic Pulmonary Sequelae Post-COVID19 Infection →

Sponsor

Institut d'Investigació Biomèdica de Bellvitge — full company profile →

Who can join

18 and older, any sex, with Fibrotic Pulmonary Sequelae Post-COVID19 Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Study population: Patients with fibrotic lung sequelae after recovery from acute phase of severe COVID19 pneumonia Objectives: To evaluate the effect of pirfenidone administered for 24 weeks in patients who have pulmonary fibrotic changes after suffering severe COVID19 pneumonia, analysed by

* % change in forced vital capacity (FVC)
* % fibrosis in high resolution computed tomography (HRCT) of the lung

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Lung epithelial and endothelial damage, loss of tissue repair, inhibition of fibrinolysis, and cellular senescence in fatal COVID-19.
   D'Agnillo F, Walters KA, Xiao Y, Sheng ZM, et al · · 2021 · cited 195× · PMID 34648357 · DOI 10.1126/scitranslmed.abj7790
2. Lung Fibrosis after COVID-19: Treatment Prospects.
   Bazdyrev E, Rusina P, Panova M, Novikov F, et al · · 2021 · cited 123× · PMID 34451904 · DOI 10.3390/ph14080807
3. Respiratory sequelae of COVID-19: pulmonary and extrapulmonary origins, and approaches to clinical care and rehabilitation.
   Singh SJ, Baldwin MM, Daynes E, Evans RA, et al · · 2023 · cited 114× · PMID 37216955 · DOI 10.1016/s2213-2600(23)00159-5
4. Recovering from a pandemic: pulmonary fibrosis after SARS-CoV-2 infection.
   Mylvaganam RJ, Bailey JI, Sznajder JI, Sala MA, et al · · 2021 · cited 74× · PMID 34911696 · DOI 10.1183/16000617.0194-2021
5. Pirfenidone for Idiopathic Pulmonary Fibrosis and Beyond.
   Aimo A, Spitaleri G, Nieri D, Tavanti LM, et al · · 2022 · cited 60× · PMID 35516794 · DOI 10.15420/cfr.2021.30
6. Clinical trials on the pharmacological treatment of long COVID: A systematic review.
   Chee YJ, Fan BE, Young BE, Dalan R, et al · · 2023 · cited 55× · PMID 36349400 · DOI 10.1002/jmv.28289
7. Research progress on drugs targeting the TGF-β signaling pathway in fibrotic diseases.
   Shi N, Wang Z, Zhu H, Liu W, et al · · 2022 · cited 49× · PMID 35147920 · DOI 10.1007/s12026-022-09267-y
8. Pulmonary fibrosis from molecular mechanisms to therapeutic interventions: lessons from post-COVID-19 patients.
   Giacomelli C, Piccarducci R, Marchetti L, Romei C, et al · · 2021 · cited 48× · PMID 34687672 · DOI 10.1016/j.bcp.2021.114812