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Tyrosine Kinase Inhibitor

Nintedanib for COVID-19 Related Lung Disease (ENDCOV-I Trial)

Phase 4
Waitlist Available
Led By Maria Padilla, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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%
Subjects Age ≥ 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 90-180 days
Awards & highlights

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.

Who is the study for?
Adults over 18 who had COVID-19 and now have lung issues like needing extra oxygen or having a history of low blood oxygen levels. They must be at least 30 days past their initial symptoms, show signs of lung damage on a CT scan, and not currently have an active SARS-CoV-2 infection. Women able to have children must use effective birth control.Check my eligibility
What is being tested?
The study is testing if Nintedanib can slow down lung disease in patients with lasting lung injury from COVID-19 compared to a placebo. Participants will either receive the actual drug or a placebo without knowing which one they are taking.See study design
What are the potential side effects?
Nintedanib may cause stomach problems like diarrhea, nausea, and liver issues. It might also lead to bleeding or heart attack within the first three months of treatment.

ENDCOV-I Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I needed extra oxygen or had low oxygen levels after getting COVID-19.
Select...
I am 18 years old or older.
Select...
My lung function tests show reduced capacity.
Select...
I needed extra oxygen or a ventilator after my COVID-19 diagnosis.

ENDCOV-I Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 90-180 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 90-180 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Change in 6 minute walk test
Lung
Change in Forced Vital Capacity (FVC)
+14 more

Side effects data

From 2017 Phase 4 trial • 105 Patients • NCT02579603
31%
Diarrhoea
16%
Dyspnoea
12%
Nausea
12%
Vomiting
12%
Fatigue
10%
Decreased appetite
8%
Abdominal pain upper
6%
Asthenia
6%
Weight decreased
6%
Abdominal pain
6%
Contusion
6%
Dizziness
6%
Cough
4%
Bronchitis
4%
Nasopharyngitis
2%
Atrial flutter
2%
Transient ischaemic attack
2%
Gastrooesophageal reflux disease
2%
Phlebitis
2%
Constipation
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Pyrexia
2%
Acute respiratory failure
2%
Pancreatitis acute
2%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nintedanib
Nintedanib + Pirfenidone

ENDCOV-I Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: NintedanibExperimental Treatment1 Intervention
150 mg PO twice a day, taken with food, (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
Group II: PlaceboPlacebo Group1 Intervention
placebo equivalent 150mg PO twice a day, taken with food food (or, for Child-Pugh A patients, 100 mg by mouth twice daily).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nintedanib
2015
Completed Phase 4
~3680

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
852 Previous Clinical Trials
535,829 Total Patients Enrolled
1 Trials studying Pulmonary Fibrosis
49 Patients Enrolled for Pulmonary Fibrosis
Boehringer IngelheimIndustry Sponsor
2,494 Previous Clinical Trials
11,338,875 Total Patients Enrolled
58 Trials studying Pulmonary Fibrosis
46,364 Patients Enrolled for Pulmonary Fibrosis
Maria Padilla, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
2 Previous Clinical Trials
313 Total Patients Enrolled
2 Trials studying Pulmonary Fibrosis
313 Patients Enrolled for Pulmonary Fibrosis

Media Library

Nintedanib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04619680 — Phase 4
Pulmonary Fibrosis Research Study Groups: Nintedanib, Placebo
Pulmonary Fibrosis Clinical Trial 2023: Nintedanib Highlights & Side Effects. Trial Name: NCT04619680 — Phase 4
Nintedanib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04619680 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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)."

Answered by AI

How widespread is the implementation of this trial?

"Seven medical centres are currently collaborating on this trial, including University of Utah in Salt Lake City, Icahn School of Medicine at Mount Sinai in New york and The Johns Hopkins Hospital located in Baltimore."

Answered by AI

Who else is applying?

What state do they live in?
Rhode Island
How old are they?
65+
What site did they apply to?
Mount Sinai Beth Israel
What portion of applicants met pre-screening criteria?
Met criteria
~0 spots leftby Apr 2024