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Efficacy and Safety of Nintedanib in the Treatment of Pulmonary Fibrosis in Patients With Moderate to Severe COVID -19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04338802
Recruitment Status : Not yet recruiting
First Posted : April 8, 2020
Last Update Posted : April 8, 2020
Sponsor:
Information provided by (Responsible Party):
Huilan Zhang, Tongji Hospital

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 fibrosis in patients with moderate to severe COVID-19.

Condition or disease Intervention/treatment Phase
COVID-19 Nintedanib Safety Effect of Drugs Drug: Nintedanib 150 MG Other: Placebo Phase 2

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 fibrosis in patients with moderate to severe COVID-19. The number of cases is estimated based on the following:

This exploratory trial is expected to complete 80 case studies (randomly divided into control group and test group each with 40 cases), and the expected drop-out rate is not more than 20%, so the total number of cases is 96. Placebo control group:

Empty capsules with the same appearance and ingredients as Nintedanib soft capsules: one capsule at a time, twice a day, with an interval of about 12 hours each time. Continuous medication for 8 weeks.

Nintedanib Nintedanib cloth sulfonate soft capsule treatment: According to the drug manual recommendation, give Nintedanib cloth sulfonate soft capsule 150mg twice daily with an interval of about 12 hours each time, with food. Continuous medication for 8 weeks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Nintedanib Ethanesulfonate Soft Capsule in the Treatment of Pulmonary Fibrosis in Patients With Moderate to Severe COVID-9(COVID 19) : a Single-center, Randomized, Placebo-controlled Study
Estimated Study Start Date : April 2, 2020
Estimated Primary Completion Date : May 4, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo group
Empty capsules with the same appearance and ingredients as Nintedanib soft capsules: one capsule at a time, twice a day, with an interval of about 12 hours each time. Continuous medication for 8 weeks.
Other: Placebo
Empty capsules with the same appearance and ingredients as Nidanib soft capsules: one capsule at a time, twice a day, with an interval of about 12 hours each time. Continuous medication for 8 weeks.

Experimental: Nintedanib group
Nintedanib cloth sulfonate soft capsule treatment: According to the drug manual recommendation, give Nintedanib cloth sulfonate soft capsule 150mg twice daily with an interval of about 12 hours each time. Continuous medication for 8 weeks.
Drug: Nintedanib 150 MG
Nintedanib cloth sulfonate 150 mg, twice a day, about 12 hours apart. Continuous medication for 8 weeks.




Primary Outcome Measures :
  1. Changes in forced vital capacity (FVC) [ Time Frame: 8 weeks ]
    Changes in forced vital capacity (FVC) after treatment compared to baseline.


Secondary Outcome Measures :
  1. Changes in carbon monoxide dispersion (DLco%) [ Time Frame: 8 weeks ]
    Changes incarbon monoxide dispersion (DLco%) after treatment compared to baseline.

  2. Changes in the six-minute walk test (6MWT) [ Time Frame: 8 weeks ]
    Changes in the six-minute walk test (6MWT) after treatment compared to baseline.

  3. Changes in High resolution CT score [ Time Frame: 8 weeks ]
    Changes in High resolution CT score after treatment compared to baseline.The minimum and maximum values are 0 and 25 , and higher scores mean a worse outcome. As for the score, it is the expected value and will be determined according to the actual result



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18-70 years old (including 18 and 70 years old), regardless of gender;
  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 ≤ 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;
  5. Signed informed consent.

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 judges uncomfortable to participate in trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04338802


Contacts
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Contact: Huilan Zhang, PD 15391532171 Huilanz_76@163.com
Contact: Xianglin Yuan, PD 13667241722 yuanxianglin@hust.edu.cn

Sponsors and Collaborators
Huilan Zhang
Publications:
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Responsible Party: Huilan Zhang, Director of Respiratory and Critical Care Medicine , Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, Tongji Hospital
ClinicalTrials.gov Identifier: NCT04338802    
Other Study ID Numbers: huilanz Zhang
First Posted: April 8, 2020    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Lung Diseases
Respiratory Tract Diseases
Nintedanib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action