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Nintedanib for COVID-19 Related Lung Disease (ENDCOV-I Trial)
ENDCOV-I Trial Summary
This trial is testing if a drug can help people with COVID-19 who have lung problems more than a month after their diagnosis.
ENDCOV-I Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowENDCOV-I Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2017 Phase 4 trial • 105 Patients • NCT02579603ENDCOV-I Trial Design
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- I have liver disease or my liver tests are higher than normal.I am 18 years old or older.I have had a heart attack in the last 90 days.You have been diagnosed with COVID-19 using a PCR test or positive blood tests.You have an active hepatitis A, B, or C infection confirmed by blood tests.I have a lung condition known as interstitial lung disease.I am currently on a high dose of blood thinners.You had a confirmed case of COVID-19 as shown by a PCR test or positive antibodies.I needed extra oxygen or had low oxygen levels after getting COVID-19.I am 18 years old or older.My lung function tests show reduced capacity.You are allergic to nintedanib, peanuts, soy, or any of the other ingredients in the medication.You must have had COVID-19 symptoms at least 30 days ago.I needed extra oxygen or a ventilator after my COVID-19 diagnosis.You have signs of lung disease on a CT scan, such as unusual patterns or thickening in the lungs.You must have had COVID-19 symptoms for at least 30 days.I am currently diagnosed with COVID-19 by a doctor.Your CT scan shows signs of lung disease.I am not in the ICU or on any form of mechanical breathing support.My kidney function is low or I am on dialysis.I have experienced a life-threatening bleeding event.I am taking more than 10 mg of Prednisone or similar drugs daily.I have a lung infection on top of another lung condition.You are taking other experimental drugs for treating COVID-19.I do not have unstable blood pressure or shock.
- Group 1: Nintedanib
- Group 2: Placebo
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is Nintedanib deemed a secure medication for individuals?
"According to our assessment, Nintedanib is rated at a 3 for safety as it has reached Phase 4 trials and thus obtained its medical license."
What maladies is Nintedanib typically prescribed to treat?
"Nintedanib is a viable treatment option for those suffering from adenocarcinoma, metastatic non-small cell lung cancer (nsclc) caused by adenocarcinoma, and pharmacotherapy."
Are there still opportunities for enrollment in this clinical investigation?
"According to clinicaltrials.gov, this medical study is actively seeking participants. First posted on November 18th 2020 and most recently edited on October 9th 2022, it is now open for enrolment."
Could you provide a list of studies previously conducted on Nintedanib?
"At the present moment, there are 19 research efforts in progress that focus on Nintedanib. 5 of those active investigations are classified as Phase 3 trials. Although most of these experiments take place in Chicago, Illinois, a large number (254) locations across America have been approved to host studies related to this medication."
Does this trial represent a pioneering exploration of the topic?
"Since its initial trial in 2012, sponsored by Boehringer Ingelheim, nintedanib has undergone extensive research and experimentation. This procedure culminated with the drug's Phase 1 & 2 approval. At present, 19 separate studies of nintedanib are being conducted across 30 countries and 53 cities worldwide."
How many participants are engaged in this clinical experiment?
"The sponsor, Boehringer Ingelheim, requires 170 eligible participants to successfully complete the clinical trial in various locations such as University of Utah (Salt Lake City) and Icahn School of Medicine at Mount Sinai (New york)."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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