Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 9 for:    COVID | Boehringer
Previous Study | Return to List | Next Study

ACTION ON COVID-19: A Study to Test Whether BI 764198 Helps Lung Health of People Hospitalised With 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: NCT04604184
Recruitment Status : Recruiting
First Posted : October 27, 2020
Last Update Posted : February 23, 2021
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:

This study is open to adults with COVID-19 infection who are in hospital and receive oxygen. Participants need to be 50 years of age or older and need to be at risk of further worsening of their condition.

The purpose of the study is to find out whether a medicine called BI 764198 helps people with COVID-19 infection and breathing problems. BI 764198 may prevent cell death and swelling of the lung tissue and therefore help patients with COVID-19 infection.

Participants are put into 2 groups by chance. One group of participants gets BI 764198 capsules and the other group gets placebo capsules. The placebo capsules look exactly like the BI 764198 capsules but do not contain any medicine. Participants take 1 capsule per day.

Participants are in the study for about a month. At study end, doctors compare the 2 groups for the number of patients that are alive and do not need mechanical breathing support. During the study, the doctors collect information on any health problems of the participants.


Condition or disease Intervention/treatment Phase
COVID-19 Drug: BI 764198 Drug: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: BI 764198 Efficacy and Safety in Prevention/Progression of ARDS and ARDS-related Complications Secondary to COVID-19 (ACTION ON COVID-19)
Actual Study Start Date : November 3, 2020
Estimated Primary Completion Date : March 20, 2021
Estimated Study Completion Date : May 26, 2021

Arm Intervention/treatment
Experimental: Treatment group Drug: BI 764198
BI 764198

Placebo Comparator: Placebo group Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Patients alive and free of mechanical ventilation [ Time Frame: At Day 29 ]

Secondary Outcome Measures :
  1. Patients alive and discharged free of oxygen [ Time Frame: At Day 29 ]
  2. Patients with occurrence of any component of composite: In-hospital mortality or intensive care unit (ICU) admission or mechanical ventilation [ Time Frame: At Day 29 ]
  3. Time to response [ Time Frame: Up to Day 29 ]
    Clinical improvement of at least 2 points (from randomisation) on the World Health Organization Clinical Progression Scale, discharge from the hospital, or considered fit for discharge (a score of 0, 1, 2, or 3 on the Clinical Progression Scale), whichever comes first. The scale provides a measure of illness severity across a range from 0 (not infected) to 10 (dead).

  4. Number of ventilator free days [ Time Frame: Up to Day 29 ]
  5. Mortality [ Time Frame: At Day 15, 29, 60 and 90 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 50 years
  • SARS-CoV-2 infection positive confirmed by PCR or approved point-of-care test
  • A score of 5 (hospitalised; oxygen by mask or nasal prongs) or 6 (hospitalised; oxygen by non-invasive ventilation or high flow), but not previously ≥7, on the WHO Clinical Progression Scale.
  • Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
  • Male or female patients. Women of childbearing potential (WOCBP) and men able to father a child must abstain from male female sex or must use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly during hospitalisation for at least 7 days after last trial drug intake

Exclusion Criteria:

  • Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) >5 × the upper limit of normal (ULN).
  • Known active infection with HIV or hepatitis B or C.
  • Pulmonary oedema/respiratory failure due to cardiogenic insult.
  • Previous to hospitalisation, on long-term oxygen therapy.
  • A confirmed baseline prolongation of QTc interval to greater than 450 ms in males or 470 ms in females according to the Bazett formula, or any other relevant ECG finding at screening, or concomitant use of medication prolonging QT interval.
  • Stage 4 severe chronic kidney disease or requiring dialysis (i.e., eGFR <30 mL/min/1.73 m2).

History of the following cardiac conditions:

  • Myocardial infarction within 3 months prior to the first dose
  • Unstable angina
  • History of clinically significant long QT features on electrocardiogram (ECG) or history of familial long QT

    • Anticipated transfer/discharge to another hospital or care facility other than their place of residence
    • Further exclusion criteria apply

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): NCT04604184


Contacts
Layout table for location contacts
Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
Show Show 25 study locations
Sponsors and Collaborators
Boehringer Ingelheim
Additional Information:
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT04604184    
Other Study ID Numbers: 1434-0009
2020-003211-96 ( EudraCT Number )
First Posted: October 27, 2020    Key Record Dates
Last Update Posted: February 23, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://trials.boehringer-ingelheim.com/trial_results/clinical_submission_documents.html to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link http://trials.boehringer-ingelheim.com/ to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
URL: https://trials.boehringer-ingelheim.com

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No