NCT04653831

Treatment With Pirfenidone for COVID-19 Related Severe ARDS

Treatment With Pirfenidone for COVID-19 Related Severe ARDS An Open Label Pilot Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Soroka University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The objective of the trial is to evaluate the safety and efficacy of treatment with Pirfenidone vs SoC in COVID-19 induced severe Acute Respiratory Distress Syndrome (ARDS) requiring mechanical ventilation. Following initial diagnosis of COVID-19, severe ARDS patient will be admitted to a dedicated intensive care unit (ICU) at Soroka University Medical Center (Day 0). Upon admission, patients will be randomized according to 1:1 ratio to one of the trial arms and receive either Pirfenidone 2,403mg administered through nasogastric tube as 801mg TID (intervention arm) plus SoC or only SoC treatment (control arm). Patients' vital signs (temperature, blood pressure, pulse rate per minute, breath rate per minute, oxygen saturation) urine output, ventilation settings, and respiratory parameters will be monitored according to SoC. Symptom will be captured daily from patients as well as adverse events (AEs) assessment and recording of the need for any supportive care during the period of ICU admission.

Conditions

• Covid19
• ARDS

Interventions

Type	Name	Description
DRUG	Pirfenidone	Treatment with Pirfenidone as mentioned in the experimental arm description.
OTHER	Standard of care	Treatment with SoC as mentioned in the control arm description.

Timeline

• Start date: 2020-11-08
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2020-12-04
• Last updated: 2023-05-23

Locations

1 site across 1 country: Israel