Treatment With Pirfenidone for COVID-19 Related Severe ARDS

Soroka University Medical Center26 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Covid19 ARDS

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Soroka Medical Center

Beersheba, Israel

Outcomes

Primary Outcomes

Ventilation free days to day 28 (VFD28)

Measured in number of days

Time frame: Up to 28 days from admission to ICU

Severe adverse events (SAEs) rate

Number of SAEs divided to number of patients