An interventional study of Pirfenidone and Standard of care in Covid19 and ARDS, sponsored by Soroka University Medical Center. Completed at 1 site in Israel. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-05-23.
Sponsored by Soroka University Medical Center · Not applicable, Interventional, and Treatment
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.
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This study's enrollment of 26 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
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Exclusion Criteria:
Standard of care (Soc) according to current guidelines and the discretion of treating physician.
Other: Standard of care
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.
Drug: Pirfenidone
Treatment with Pirfenidone as mentioned in the experimental arm description.
Also known as: Intervention Arm
Treatment with SoC as mentioned in the control arm description.
Also known as: Control Arm
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
Time frame: Through study completion, an average of 1 year
Mortality
Includes all cause mortality, mortality in the ICU, 28 days mortality, 60 days mortality, in-hospital mortality, and ARDS related mortality. Measured in number of days.
Time frame: Through study completion, an average of 1 year
ICU length of stay
Measured in number of days
Time frame: Through study completion, an average of 1 year
Lung compliance
Part of mechanical ventilation parameters, calculated as tidal volume divided by the difference between plateau pressure and PEEP. Daily average will be assessed until extubation. Units are mL/cmH2O.
Time frame: Through study completion, an average of 1 year
Tidal Volume
Part of mechanical ventilation parameters, it is the lung volume representing the volume of air displaced between normal inhalation and exhalation. Measured continuously by the ventilator, calculated and represented as area under the curve after omitting extreme values \<5 and \>95 percentiles. Measured in mL.
Time frame: Through study completion, an average of 1 year
Positive End Expiratory Pressure (PEEP)
Part of mechanical ventilation parameters, it is the pressure in the lungs above atmospheric pressure that exists at the end of expiration. It is set by the treating physicians according to the clinical situation of the patient, and will be documented daily until extubation. Measured in cmH2O.
Time frame: Through study completion, an average of 1 year
Driving Pressure
Part of mechanical ventilation parameters, it is the difference between plateau pressure and PEEP. Measured continuously by the ventilator, calculated and represented as area under the curve after omitting extreme values \<5 and \>95 percentiles.
Time frame: Through study completion, an average of 1 year
Quality of life questionnaire
Assessed by St George Respiratory Questionnaire (SGRQ). Scoring range from 0 to 100, with higher scored indicating more limitation.
Time frame: on admission and 6 months after discharge
Vital Capacity (VC)
Part of pulmonary function tests, it is the maximum amount of air a person can expel from the lungs after a maximum inhalation. Measured on a spirometer in mL.
Time frame: On admission (if possible) and 6 months after discharge
Forced Vital Capacity (FVC)
Part of pulmonary function tests, it is the vital capacity that results from a maximally forced expiratory effort. Measured on a spirometer in mL.
Time frame: On admission (if possible) and 6 months after discharge
Forced Expiratory Volume at first second (FEV1)
Part of pulmonary function tests, it is the volume of air exhaled at the end of the first second of forced expiration. Measured on a spirometer in mL.
Time frame: On admission (if possible) and 6 months after discharge
Diffusing Capacity for Carbon Monoxide (DLCO)
Part of pulmonary function tests, it is the extent to which oxygen passes from the air sacs of the lungs into the blood. Measured on a spirometer in mL/min/kPa.
Time frame: On admission (if possible) and 6 months after discharge
6 minutes walking test
The distance covered over a time of 6 minutes, measured in meters.
Time frame: 6 months after discharge from hospital
Plan to share: No
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Soroka University Medical Center