Treatment With Pirfenidone for COVID-19 Related Severe ARDS

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A randomized, open label, two arm, pilot trial of Pirfenidone 2,403 mg administered per nasogastric tube or orally as 801mg TID for 4 weeks in addition to Standard of Care (SoC), compared to SoC alone, in a population of COVID-19 induced severe ARDS. Patients will be randomized according to 1:1 ratio to one of the trial arms: Pirfenidone (intervention arm) or SoC (control arm).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Soroka University Medical Center
• Collaborator: Roche Pharma AG
• Treatments: Pirfenidone

Criteria

Inclusion Criteria:

• Men and women between the ages 18-80 years

• Diagnosis of COVID19 with severe ARDS (PaO2/FIO2 <150mmHg)

• Admission to the ICU and in need of mechanical ventilation

• Able to give informed consent according to local regulations. If the patient is unable to give written informed consent, the form will be read to them and their verbal consent will be documented. If the patient is sedated, an impartial ICU physician will approve eligibility.

Exclusion Criteria:

• Previous use of nintedanib or pirfenidone

• Administration of fluvoxamine 7 days prior to admission to ICU

• Severe hepatic impairment (liver enzymes and bilirubin>2 of normal upper limit, at day 0) or end stage liver disease

• Severe renal impairment (CrCl <30 ml/min) or end stage renal disease requiring dialysis

• Pregnancy

• Participation in any other clinical trial 30 days prior to enrollment