CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 26 enrolled
Drug / intervention
Pirfenidone +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04653831
NCT04653831N/ACompleted

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

Soroka University Medical Center·interventional·Posted Dec 4, 2020·Updated May 23, 2023

In Brief

A clinical study evaluating Pirfenidone and Standard of care for Covid19 and ARDS. Completed, enrolled 26 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCovid19, ARDS
CountriesIsrael
CollaboratorsRoche Pharma AG

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedDec 4, 2020
Enrollment StartNov 8, 2020
Primary CompletionDec 31, 2022
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 5.6 years ago

Interventions

Pirfenidonedrug

Treatment with Pirfenidone as mentioned in the experimental arm description.

Standard of careother

Treatment with SoC as mentioned in the control arm description.