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IRCT20200314046764N1 IRCT 2020-04-20 Kermanshah University of Medical Sciences 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 2020-04-26 anticipated 40 Complete https://irct.ir/trial/46533 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to prevent bias, a simple randomization method will be used in this study to perform random allocation. We will produce 40 cards , completely identical in appearance. "Number 1" will be written on 20 of them indicating the intervention and on the other 20 cards left, we will write "number 2" which indicates the control group. Each eligible participant then randomly picks one of these cards, which determines how the patients will be randomly assigned to each group. Without the trial participants being informed of the nature of either 1 or 2 numbers, Blinding description: I this study the researcher, questionnaire data recorder, the radiologist evaluating imaging findings, outcome assessors, and data analyser are unaware of patients' affiliation to each group. 3 Pulmonary fibrosis and acute respiratory distress syndrome caused by novel corona-virus pneumonia (COVID-19). 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, Chloroquine 250 mg twice daily, and Osiltamivir 75 mg twice daily, in critically ill patients with ribavirin 1200 twice daily. ). Intervention 2: Control group: In the control group, standard treatment according to the national protocol containing Coltra (Lupinavir / Ritonavir) 100mg/400mg twice daily, chloroquine 250 mg twice daily, and siltamivir 75 mg twice daily in critically ill patients with ribavirin 1200 twice daily. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Bahareh Baghchi
Baghabrisham Ave., Parastar Blvd., Medicine school
Kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3427 4618 bahareh.baghchi@kums.ac.ir Kermanshah University of Medical Sciences scientific Bahareh Baghchi
Baghabrisham Ave., Parastar Blvd., Medicine school
Kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3427 4618 bahareh.baghchi@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Both 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: ① Severe hypertension within 6 months of Visit 1, uncontrollable after treatment (≥160 / 100 mmHg); ② myocardial infarction within 6 months of visit 1; ③ 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 B34.2 Coronavirus infection, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Pirfenidone 200 mg ,three times daily in addition to standard treatment (according to the national protocol) containing Coltra Lupinavir / Ritonavir twice daily, Chloroquine 250 mg twice daily, and Osiltamivir 75 mg twice daily, in critically ill patients with ribavirin 1200 twice daily. ) Control group: In the control group, standard treatment according to the national protocol containing Coltra (Lupinavir / Ritonavir) 100mg/400mg twice daily, chloroquine 250 mg twice daily, and siltamivir 75 mg twice daily in critically ill patients with ribavirin 1200 twice daily. 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. 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. Kermanshah University of Medical Sciences Approved 2020-03-03 Ethics committee of Kermanshah University of Medical Sciences Branch of researchs and industry,Kermanshah University Of Medical Sciences, Shahid Beheshti Blvd, Kermanshah, Iran Kermanshah Kermanshah Iran (Islamic Republic of)