Ignite Creation Date:
2024-05-06 @ 3:29 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04653831
Status:
COMPLETED
Last Update Posted:
2023-05-23
First Post:
2020-10-27
Brief Title:
Treatment With Pirfenidone for COVID-19 Related Severe ARDS
Sponsor:
Soroka University Medical Center
Organization:
Soroka University Medical Center
Study Overview
Official Title:
Treatment With Pirfenidone for COVID-19 Related Severe ARDS An Open Label Pilot Trial
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A randomized open label two arm pilot trial of Pirfenidone 2403 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 11 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 11 ratio to one of the trial arms and receive either Pirfenidone 2403mg 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
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 11 ratio to one of the trial arms and receive either Pirfenidone 2403mg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None