Last updated on July 2020

A Study to Evaluate the Efficacy and Safety of Pirfenidone With Novel Coronavirus Infection

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Pulmonary Disease | Pirfenidone | *Corona Virus Infection | Pneumonia | Covid-19 | Novel Coronavirus Pneumonia | Throat and Tonsil Infections | Pneumonia (Pediatric) | Lung Disease | *COVID-19 | Upper respiratory infection
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

(1) Age 18 years. (2) Clinically diagnosed patients with new type of coronavirus pneumonia include: on the basis of meeting the criteria for suspected cases, one of the following pathogenic evidence: real-time fluorescent RT-PCR of respiratory specimens or blood specimens for detection of new coronavirus nucleic acid; Respiratory or blood specimens are genetically sequenced and highly homologous to known new coronaviruses. (3) The time interval between the suspected neocoronary pneumonia pneumonia case and the random enrollment is determined within 4 days to 7 days according to the history symptoms and chest CT imaging. Cough, diarrhea, or other related symptoms can be used. The imaging changes are mainly based on chest CT.

Exclusion Criteria:

(1) AST and ALT> 1.5 x ULN at visit 1; (2) bilirubin> 1.5 x ULN at visit 1; (3) creatinine clearance rate calculated by Cockcroft-Gault formula at visit 1 <30 mL / min; (4) patients with potential chronic liver disease (Child Pugh A, B or C liver injury; (5) previous treatment with nidanib or pirfenidone; (6) screening visits (interviews 1) Received other research drug treatment within 1 month or 6 half-lives (whichever is greater); (7) IPF diagnosis based on ATS / ERS / JRS / ALAT 2011 guidelines (P11-07084); (8 ) Significant pulmonary hypertension (PAH) defined by any of the following standards: Clinical / echocardiographic evidence of previously significant right heart failure; Medical history including right heart catheter showing a cardiac index 2l / min / m2; Prostaglandol / qu Parenteral administration of prostacyclin in the treatment of PAH; (9) other clinically significant lung abnormalities considered by the investigator; (10) major extrapulmonary physiological limitations (such as chest wall deformity, large amount of pleural effusion); (11) Cardiovascular diseases, 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; (12) history of severe central nervous system (CNS) events; (13) known trials Drug allergies; (14) Other diseases that may interfere with the testing process or as judged by the investigator may interfere with the trial participation or may put the patient at risk when participating in the trial; (15) Women who are pregnant, breastfeeding, or planning pregnancy in this trial (16) Patients are unable to understand or follow the trial procedures, including completing the questionnaires themselves without assistance.

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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