Study Stopped
Company decision
ACTION ON COVID-19: A Study to Test Whether BI 764198 Helps Lung Health of People Hospitalised With COVID-19
BI 764198 Efficacy and Safety in Prevention/Progression of ARDS and ARDS-related Complications Secondary to COVID-19 (ACTION ON COVID-19)
2 other identifiers
interventional
133
6 countries
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 covid19
Started Nov 2020
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2020
CompletedFirst Posted
Study publicly available on registry
October 27, 2020
CompletedStudy Start
First participant enrolled
November 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 24, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2021
CompletedResults Posted
Study results publicly available
April 11, 2022
CompletedApril 11, 2022
April 1, 2022
5 months
October 26, 2020
March 22, 2022
April 7, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Patients Alive and Free of Mechanical Ventilation
Percentage of patients alive and free of mechanical ventilation at Day 29 is presented. One patient had no creatinine at baseline value and was therefore excluded from the statistical analysis (N=128).
At Day 29
Secondary Outcomes (5)
Percentage of Patients Alive and Discharged Free of Oxygen Use
At Day 29
Percentage of Patients With Occurrence of Any Component of Composite: In-hospital Mortality or Intensive Care Unit (ICU) Admission or Mechanical Ventilation
At Day 29
Time to 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
Up to Day 29
Number of Ventilator Free Days
Up to Day 29
Percentage of Mortality at Day 15, 29, 60 and 90
At Day 15, 29, 60 and 90
Study Arms (2)
BI 764198 treatment group
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
University of California Irvine
Orange, California, 92868, United States
Rapides Regional Medical Center
Alexandria, Louisiana, 71301, United States
St. Elizabeth's Medical Center
Boston, Massachusetts, 02135, United States
Newton-Wellesley Hospital
Newton, Massachusetts, 02462, United States
Mercy Health St. Vincent Medical Center
Toledo, Ohio, 43608, United States
Providence Regional Medical Center
Everett, Washington, 98201, United States
MultiCare Tacoma General Hospital
Tacoma, Washington, 98405, United States
Hospital Luxemburgo
Belo Horizonte, 32380-490, Brazil
IPECC - Instituto de Pesquisa Clínica de Campinas
Campinas, 13060-080, Brazil
Hospital Ernesto Dornelles
Porto Alegre, 90160-092, Brazil
Hospital Regional Hans Dieter Schmidt
Santa Catarina, 89227, Brazil
Hospital de Base - Fac Med de Sao Jose do Rio Preto
São José do Rio Preto, 15090-000, Brazil
Hospital Padre Alberto Hurtado
Santiago, 8880465, Chile
Hospital Carlos Van Buren
Valparaíso, 2341131, Chile
Hospital Cardiologica Aguascalientes
Aguascalientes, 20230, Mexico
Hospital General de Culiacán "Dr. Bernardo J. Gastellum"
Culiacán, 80230, Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, 64460, Mexico
Hospital Auxilio Mutuo
Hato Rey, 00919, Puerto Rico
Hospital Municipal de San Juan
Rio Piedras, 00936, Puerto Rico
Hospital A Coruña
A Coruña, 15006, Spain
Hospital General Universitario de Alicante
Alicante, 03010, Spain
Hospital Universitario Infanta Leonor
Madrid, 28031, Spain
Hospital Clínico San Carlos
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Son Espases
Palma de Mallorca, 07120, Spain
Related Publications (1)
Ware LB, Soleymanlou N, McAuley DF, Estrada V, Diaz GA, Lacamera P, Kaste R, Choi W, Gupta A, Welte T. TRPC6 inhibitor (BI 764198) to reduce risk and severity of ARDS due to COVID-19: a phase II randomised controlled trial. Thorax. 2023 Aug;78(8):816-824. doi: 10.1136/thorax-2022-219668. Epub 2023 Apr 6.
PMID: 37024277DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This trial was terminated early following the recommendation of a Data Monitoring Committee.
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2020
First Posted
October 27, 2020
Study Start
November 3, 2020
Primary Completion
March 24, 2021
Study Completion
May 31, 2021
Last Updated
April 11, 2022
Results First Posted
April 11, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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'.
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing 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 https://www.mystudywindow.com/msw/datasharing 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.