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Can a lung drug stop COVID scarring?

NCT ID NCT04619680

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

103 people

The number who actually took part.

Started

Nov 2020

Finished

Mar 2024

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Baylor University Medical Center Dallas

    Dallas, Texas, 75246, United States

  • Emory Healthcare Network

    Atlanta, Georgia, 30322, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Mount Sinai Beth Israel

    New York, New York, 10003, United States

  • The Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • University of Utah

    Salt Lake City, Utah, 84108, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.