Clinical trial NCT04604184: ACTION ON COVID-19: A Study to Test Whether BI 764198 Helps Lung Health of People Hospitalised With COVID-19
Official title: BI 764198 Efficacy and Safety in Prevention/Progression of ARDS and ARDS-related Complications Secondary to COVID-19 (ACTION ON COVID-19)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2020-10-27
Enrollment: 133
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Percentage of Patients Alive and Free of Mechanical Ventilation
timeFrame: At Day 29
Secondary outcomes:
measure: Percentage of Patients Alive and Discharged Free of Oxygen Use
timeFrame: At Day 29
measure: Percentage of Patients With Occurrence of Any Component of Composite: In-hospital Mortality or Intensive Care Unit (ICU) Admission or Mechanical Ventilation
timeFrame: At Day 29
measure: 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
timeFrame: Up to Day 29
measure: Number of Ventilator Free Days
timeFrame: Up to Day 29
measure: Percentage of Mortality at Day 15, 29, 60 and 90
timeFrame: At Day 15, 29, 60 and 90
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California Irvine
state: California
city: Alexandria
country: United States
facility: Rapides Regional Medical Center
state: Louisiana
city: Boston
country: United States
facility: St. Elizabeth's Medical Center
state: Massachusetts
city: Newton
country: United States
facility: Newton-Wellesley Hospital
state: Massachusetts
city: Toledo
country: United States
facility: Mercy Health St. Vincent Medical Center
state: Ohio
city: Everett
country: United States
facility: Providence Regional Medical Center
state: Washington
city: Tacoma
country: United States
facility: MultiCare Tacoma General Hospital
state: Washington
city: Belo Horizonte
country: Brazil
facility: Hospital Luxemburgo
city: Campinas
country: Brazil
facility: IPECC - Instituto de Pesquisa Clínica de Campinas
city: Porto Alegre
country: Brazil
facility: Hospital Ernesto Dornelles
city: Santa Catarina
country: Brazil
facility: Hospital Regional Hans Dieter Schmidt
city: Sao Jose do Rio Preto
country: Brazil
facility: Hospital de Base - Fac Med de Sao Jose do Rio Preto
city: Santiago
country: Chile
facility: Hospital Padre Alberto Hurtado
city: Valparaiso
country: Chile
facility: Hospital Carlos Van Buren
city: Aguascalientes
country: Mexico
facility: Hospital Cardiologica Aguascalientes
city: Culiacán
country: Mexico
facility: Hospital General de Culiacán "Dr. Bernardo J. Gastellum"
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr Jose Eleuterio Gonzalez
city: Hato Rey
country: Puerto Rico
facility: Hospital Auxilio Mutuo
city: Rio Piedras
country: Puerto Rico
facility: Hospital Municipal de San Juan
city: A Coruña
country: Spain
facility: Hospital A Coruña
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Palma de Mallorca
country: Spain
facility: Hospital Son Espases
Study officials:
References: