Status:
UNKNOWN
A Study to Evaluate the Efficacy and Safety of Pirfenidone With Novel Coronavirus Infection
Lead Sponsor:
Huilan Zhang
Conditions:
Novel Coronavirus Pneumonia
Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The acute lung injury caused by SARS and 2003 were both related to the inflammatory cytokine storm in patients. The biochemical test showed abnormal increase in related indicators such as interleukin-...
Detailed Description
This study is a multi-center, randomized, open, blank-controlled, multi-stage clinical study. As there are no effective treatments, the project team will evaluate possible treatments (including but no...
Eligibility Criteria
Inclusion
- (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: ① 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
- (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: ① Clinical / echocardiographic evidence of previously significant right heart failure; ② Medical history including right heart catheter showing a cardiac index ≤ 2l / min / m2; ③ 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: 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; (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.
Key Trial Info
Start Date :
February 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2020
Estimated Enrollment :
294 Patients enrolled
Trial Details
Trial ID
NCT04282902
Start Date
February 4 2020
End Date
June 1 2020
Last Update
February 25 2020
Active Locations (1)
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1
Tongji hospital affiliated to huazhong university of science and technology
Wuhan, Hubei, China