Can a lung drug stop COVID scarring?
NCT ID NCT04619680
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether nintedanib, a drug used for other lung diseases, can slow down lung damage in people who had severe COVID-19. It included 103 adults who still had lung problems more than 30 days after their COVID diagnosis. The main goal was to see if the drug helped maintain lung function over 6 months.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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103 people
The number who actually took part.
- Started
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Nov 2020
- Finished
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Mar 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Willing and able to provide written informed consent * Subjects Age ≥ 18 * Initial SARS-CoV-2 infection confirmed by PCR test or positive serologies * Have findings consistent with interstitial lung disease found on CT scan (these may include ground glass opacities, reticulations, traction bronchiectasis, septal thickening, and early honeycombing) * Required one of the following after diagnosis with SARS-CoV-2: supplemental oxygen by nasal cannula, high flow oxygen, non invasive ventilation such as CPAP or BIPAP, or mechanical ventilation or a history of desaturation below 90% * Are at least 30 days from onset of initial SARS-CoV-2 symptoms * Forced Vital Capacity less than or equal to 90% predicted based on ATS/ERS criteria or DLCO less than or equal to 70% * Women of childbearing potential who agree to use of highly effective contraception during treatment and for three months following the last dose of nintedanib Exclusion Criteria: Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of the Screening Visit (prior to randomization): * Co-administration of other investigational agents against COVID-19 * Active SARS-CoV-2 infection based on clinical judgment * Currently Pregnant or Breast Feeding * Current Use of Prednisone or equivalent \> 10 mg/daily or immunosuppressive therapy or disease modifying agents * Use of full dose anticoagulation therapy or high dose anti platelet drug therapy at screening (at the discretion of the investigator, anticoagulation therapy may be added if clinically indicated) * History of myocardial infarction within past 90 days * Life threatening bleed * Hemodynamic instability or shock * Superimposed pulmonary bacterial infection * Pre-existing interstitial lung disease * Active Hep A/B/C hepatitis as measured with PCR for viral load and/or serologies * Pre-existing liver disease: Including Abnormal Laboratory Liver Function: Childs Pugh B/C, AST/ALT \> 3 times the upper limit of normal (ULN). If Child Pugh A, can participate on nintedanib 100 mg by mouth twice daily. * Subjects with a Creatinine clearance \<30 ml/min or currently on hemodialysis * Inability to tolerate orally administered medication (medication must be taken with meals) * Patients who are in the intensive care unit (ICU) or in the step-down unit on invasive or non-invasive mechanical ventilation, ECMO, or high flow nasal cannula oxygen, will not be included. * Any condition that in the opinion of the Investigator, constitute a risk or a contraindication for the participation of the patient into the study or that could interfere with the study objectives, conduct or evaluation. * Patients with known hypersensitivity to nintedanib, peanut, soy, or to any of the excipients.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Baylor College of Medicine
Houston, Texas, 77030, United States
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Baylor University Medical Center Dallas
Dallas, Texas, 75246, United States
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Emory Healthcare Network
Atlanta, Georgia, 30322, United States
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Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
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Mount Sinai Beth Israel
New York, New York, 10003, United States
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The Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
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University of Utah
Salt Lake City, Utah, 84108, United States
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Other studies related to the condition(s) this trial covers.
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