ACTION ON COVID-19: A Study to Test Whether BI 764198 Helps Lung Health of People Hospitalised With COVID-19
NCT ID: NCT04604184
Last Updated: 2022-04-11
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
133 participants
INTERVENTIONAL
2020-11-03
2021-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BI 764198 treatment group
BI 764198
BI 764198
Placebo
Placebo
Placebo
Interventions
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BI 764198
BI 764198
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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University of California Irvine
Orange, California, United States
Rapides Regional Medical Center
Alexandria, Louisiana, United States
St. Elizabeth's Medical Center
Boston, Massachusetts, United States
Newton-Wellesley Hospital
Newton, Massachusetts, United States
Mercy Health St. Vincent Medical Center
Toledo, Ohio, United States
Providence Regional Medical Center
Everett, Washington, United States
MultiCare Tacoma General Hospital
Tacoma, Washington, United States
Hospital Luxemburgo
Belo Horizonte, , Brazil
IPECC - Instituto de Pesquisa Clínica de Campinas
Campinas, , Brazil
Hospital Ernesto Dornelles
Porto Alegre, , Brazil
Hospital Regional Hans Dieter Schmidt
Santa Catarina, , Brazil
Hospital de Base - Fac Med de Sao Jose do Rio Preto
São José do Rio Preto, , Brazil
Hospital Padre Alberto Hurtado
Santiago, , Chile
Hospital Carlos Van Buren
Valparaíso, , Chile
Hospital Cardiologica Aguascalientes
Aguascalientes, , Mexico
Hospital General de Culiacán "Dr. Bernardo J. Gastellum"
Culiacán, , Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, , Mexico
Hospital Auxilio Mutuo
Hato Rey, , Puerto Rico
Hospital Municipal de San Juan
Rio Piedras, , Puerto Rico
Hospital A Coruña
A Coruña, , Spain
Hospital General Universitario de Alicante
Alicante, , Spain
Hospital Universitario Infanta Leonor
Madrid, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Son Espases
Palma de Mallorca, , Spain
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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2020-003211-96
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1434-0009
Identifier Type: -
Identifier Source: org_study_id
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