Status:
UNKNOWN
Efficacy and Safety of Nintedanib in the Treatment of Pulmonary Fibrosis in Patients With Moderate to Severe COVID -19
Lead Sponsor:
Huilan Zhang
Conditions:
COVID-19
Nintedanib
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This center intends to conduct a single-center, randomized, placebo-controlled study to evaluate the effectiveness and safety of Nintedanib ethanesulfonate soft capsule in the treatment of pulmonary f...
Detailed Description
This center intends to conduct a single-center, randomized, placebo-controlled study to evaluate the effectiveness and safety of Nintedanib ethanesulfonate soft capsule in the treatment of pulmonary f...
Eligibility Criteria
Inclusion
- 18-70 years old (including 18 and 70 years old), regardless of gender;
- Infection with new coronavirus pneumonia was confirmed by throat swab nucleic acid test. Patients with severe and critical illness were clinically judged. The symptoms of acute infection have been alleviated after treatment (at least 14 days after onset, no fever for more than 3 days), and the disease is recovering Within three months;
- CT examination of patients with multiple fibrotic shadows in both lungs;
- Blood routine, liver, and kidney functions are within the controllable range: such as the normal upper limit of plasma total bilirubin and creatinine ≤ 1.5 times; AST, ALT, LDH ≤ 2 times the normal upper limit; sufficient hematopoietic function: such as white blood cells ≥4.0 × 109 / L, platelets ≥100 × 109 / L;
- Signed informed consent.
Exclusion
- Previous history of chronic bronchitis, emphysema, interstitial lung disease or pulmonary heart disease;
- Combining with other serious diseases: such as those who have suffered myocardial infarction and uncontrollable diabetes within 6 months, and are considered unsuitable to participate in the trial;
- People with active peptic ulcer;
- Patients during pregnancy and lactation
- Patients with mental illness or others who cannot cooperate effectively;
- Researcher judges uncomfortable to participate in trial
Key Trial Info
Start Date :
April 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2020
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT04338802
Start Date
April 2 2020
End Date
August 1 2020
Last Update
April 8 2020
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