Treatment With Pirfenidone for COVID-19 Related Severe ARDS
Covid19, ARDS
About this trial
This is an interventional treatment trial for Covid19 focused on measuring Covid-19, ARDS, Pirfenidone
Eligibility 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
Sites / Locations
- Soroka Medical Center
Arms of the Study
Arm 1
Arm 2
Other
Experimental
Standard of Care - Control
Pirfenidone Treatment
Standard of care (Soc) according to current guidelines and the discretion of treating physician.
In addition to SoC, Pirfenidone 2,403 mg administered orally or per nasogastric tube as 801mg TID, for 4 weeks. Pirfenidone dose will be 2,403mg daily, from day one of admission to the ICU, titrated over 3 days: Day 1 - 801mg x 1/d (801mg) Day 2 - 801mg x 2/d (1,602 mg) Day 3 - 801mg x 3/d (2,403 mg) Feeding and medication delivery will be upon the discretion of the treating physician according to tolerability. Powdered 801mg tablets will be administered through the nasogastric tube: Each tablet will be crushed and dissolved in 20cc of water. The nasogastric tube will be flushed afterwards to avoid obstruction.. If the patient is able to swallow and the nasogastric tube is removed, pirfenidone will continue to be delivered orally.