Pirfenidine in SARS-COV2

Phase 3

Conditions: Pulmonary fibrosis and acute respiratory distress syndrome caused by novel corona-virus pneumonia (COVID-19).
Coronavirus infection, unspecified
B34.2

Registration Number: IRCT20200314046764N1

Lead Sponsor: Kermanshah University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 40

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.