Treatment With Pirfenidone for COVID-19 Related Severe ARDS
NCT ID: NCT04653831
Last Updated: 2023-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
26 participants
INTERVENTIONAL
2020-11-08
2022-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard of Care - Control
Standard of care (Soc) according to current guidelines and the discretion of treating physician.
Standard of care
Treatment with SoC as mentioned in the control arm description.
Pirfenidone Treatment
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.
Pirfenidone
Treatment with Pirfenidone as mentioned in the experimental arm description.
Interventions
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Pirfenidone
Treatment with Pirfenidone as mentioned in the experimental arm description.
Standard of care
Treatment with SoC as mentioned in the control arm description.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Roche Pharma AG
INDUSTRY
Soroka University Medical Center
OTHER
Responsible Party
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Yasmeen Abu Fraiha
Internal Medicine resident, MD
Principal Investigators
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Ori Galante, MD
Role: PRINCIPAL_INVESTIGATOR
ICU physician in SMC
Locations
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Soroka Medical Center
Beersheba, , Israel
Countries
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References
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Related Links
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A Study to Evaluate the Efficacy and Safety of Pirfenidone With Novel Coronavirus Infection
Other Identifiers
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SCRC20007
Identifier Type: -
Identifier Source: org_study_id
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