Pirfenidine in SARS-COV2

The evaluation of pirfenidone effects on prevention and treatment of pulmonary fibrosis and acute respiratory distress syndrome caused by COVID-19

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200314046764N1

Enrollment

Registered

2020-04-20

Start date

2020-04-26

Completion date

Unknown

Last updated

2020-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary fibrosis and acute respiratory distress syndrome caused by novel corona-virus pneumonia (COVID-19). Coronavirus infection, unspecified

Interventions

Intervention 1: Intervention group: Pirfenidone 200 mg ,three times daily in addition to standard treatment (according to the national protocol) containing Coltra Lupinavir / Ritonavir twice daily, C

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Confirmed cases of New coronavirus infection or COVID-19 who are 18 years and older; Not more than 14 days from the onset of symptoms Bilateral lung involvement in imaging findings Moderate to severe acute respiratory distress syndrome Decreased PaO2 to FiO2 ratio

Exclusion criteria

Exclusion criteria: AST and ALT> 3-5x ULN at visit and bilirubin> 1.5 x ULN at visit creatinine clearance rate calculated by Cockcroft-Gault formula at visit 1 <30 mL / min Confirmed previous Idiopathic pulmonary fibrosis,previous treatment with Nidanib or Pirfenidone Significant pulmonary hypertension (PAH) Cardiovascular diseases, including any of the following diseases: ? Severe hypertension within 6 months of Visit 1, uncontrollable after treatment (=160 / 100 mmHg); ? myocardial infarction within 6 months of visit 1; ? unstable angina within 6 months of visit 1 history of severe central nervous system (CNS) events known trials Drug allergies Patients unable to follow the trial procedures Pregnancy Breastfeeding

Design outcomes

Primary

Measure	Time frame
The scales of pulmonary involvement changes according to the scoring system defined, based on high resolution pulmonary computed tomography before and after the interventions. Timepoint: At visit 1 and then after 14 days. Method of measurement: Defined scoring system based on pulmonary involvement in high resolution pulmonary CT scan; score one: involvement in less than 5% of a lobe of a lung. Score two: Conflict about 25 percent of a lobe of a lung. Score three: Conflict about 26 to 49 percent of a lobe of a lung. Score four: Conflict about 50 to 75 percent of a lobe of a lung. Score Five: Conflict in more than 75% of a lobe of a lung.	—

Measure

Time frame

The scales of pulmonary involvement changes according to the scoring system defined, based on high resolution pulmonary computed tomography before and after the interventions. Timepoint: At visit 1 and then after 14 days. Method of measurement: Defined scoring system based on pulmonary involvement in high resolution pulmonary CT scan; score one: involvement in less than 5% of a lobe of a lung. Score two: Conflict about 25 percent of a lobe of a lung. Score three: Conflict about 26 to 49 percent of a lobe of a lung. Score four: Conflict about 50 to 75 percent of a lobe of a lung. Score Five: Conflict in more than 75% of a lobe of a lung.

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Secondary

Measure	Time frame
Changes in arterial gas content. Timepoint: Weekly for 2 weeks. Method of measurement: Paraclinical tests (blood tests).;Feeling nauseous. Timepoint: Daily for 14 days. Method of measurement: Through direct questioning of the patient as well as objective observations.;Shortness of breath. Timepoint: Daily for 14 days. Method of measurement: Through direct questioning of the patient as well as objective observations.;Feeling exhausted. Timepoint: Daily for 14 days. Method of measurement: Through direct questioning of the patient as well as objective observations.;Shievering. Timepoint: Daily for 14 days. Method of measurement: Through direct questioning of the patient as well as objective observations.;Cough. Timepoint: Daily for 14 days. Method of measurement: Through direct questioning of the patient as well as objective observations.	—

Measure

Time frame

Changes in arterial gas content. Timepoint: Weekly for 2 weeks. Method of measurement: Paraclinical tests (blood tests).;Feeling nauseous. Timepoint: Daily for 14 days. Method of measurement: Through direct questioning of the patient as well as objective observations.;Shortness of breath. Timepoint: Daily for 14 days. Method of measurement: Through direct questioning of the patient as well as objective observations.;Feeling exhausted. Timepoint: Daily for 14 days. Method of measurement: Through direct questioning of the patient as well as objective observations.;Shievering. Timepoint: Daily for 14 days. Method of measurement: Through direct questioning of the patient as well as objective observations.;Cough. Timepoint: Daily for 14 days. Method of measurement: Through direct questioning of the patient as well as objective observations.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactBahareh Baghchi

Kermanshah University of Medical Sciences

bahareh.baghchi@kums.ac.ir+98 83 3427 4618

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026