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Efficacy and safety of Nintedanib esilate soft capsules in the treatment of pulmonary fibrosis in healed moderate to severe patients of novel coronavirus pneumonia (COVID-19): a single-center, randomized, placebo-controlled trial

Efficacy and safety of Nintedanib esilate soft capsules in the treatment of pulmonary fibrosis in healed moderate to severe patients of novel coronavirus pneumonia (COVID-19): a single-center, randomized, placebo-controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000031453
Enrollment
Unknown
Registered
2020-04-01
Start date
2020-04-01
Completion date
Unknown
Last updated
2020-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Novel Coronavirus Pneumonia (COVID-19)

Interventions

Nintedanib group:Nintedanib
Control group:Placebo

Sponsors

Tongji Hospital of Tongji Medical College, Huazhong Science and Technology University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Aged 18 to 70 years old; 2) 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; 3) CT examination of patients with multiple fibrotic shadows in both lungs; 4) Blood routine, liver, and kidney functions are within the controllable range: such as the normal upper limit of plasma total bilirubin and creatinine =4.0x10^9/L, platelets >=100x10^9/L; 5) Signed informed consent.

Exclusion criteria

Exclusion criteria: 1) Previous history of chronic bronchitis, emphysema, interstitial lung disease or pulmonary heart disease; 2) 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; 3) People with active peptic ulcer; 4) Patients during pregnancy and lactation; 5) Patients with mental illness or others who cannot cooperate effectively; 6) Researcher judged unsuitable to participate.

Design outcomes

Primary

MeasureTime frame
FVC;

Secondary

MeasureTime frame
DLco%;6MWT;HRCT score;Change in cough;

Countries

China

Contacts

Public ContactXianglin Yuan

Tongji Hospital of Tongji Medical College; Huazhong Science and Technology University

yuanxianglin@hust.edu.cn+86 13667241722

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026