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

NCT04607928 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2021-12-30

No results posted yet for this study

Summary

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

Conditions

  • Fibrotic Pulmonary Sequelae Post-COVID19 Infection

Interventions

DRUG

Pirfenidone

Comparing the effect of pirfenidone in avoiding establishing or progression of fibrosis induced after COVID19 infection

DRUG

Placebo

Comparing the effect of pirfenidone in avoiding establishing or progression of fibrosis induced after COVID19 infection

Sponsors & Collaborators

  • Institut d'Investigació Biomèdica de Bellvitge

    lead OTHER

Principal Investigators

  • Maria Molina-Molina, MD, PhD · Institut d'Investigació Biomèdica de Bellvitge

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2022-01-30
Completion
2022-06-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04607928 on ClinicalTrials.gov