COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04282902

Huilan Zhang, PD

huilanz_76@163.com

2020-02-25

Recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

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: 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.

(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.

2

Huilan Zhang

18

None

China

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

294

blood gas;chest CT;Finger pulse oxygen;K-BILD

None

Phase 3

[{"arm_notes": "", "treatment_id": 995, "treatment_name": "Pirfenidone", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]