ACTION ON COVID-19: A Study to Test Whether BI 764198 Helps Lung Health of People Hospitalised With COVID-19

COVID-19 Clinical Trial

Official title:

BI 764198 Efficacy and Safety in Prevention/Progression of ARDS and ARDS-related Complications Secondary to COVID-19 (ACTION ON COVID-19)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04604184
• Other study ID #: 1434-0009
• Secondary ID: 2020-003211-96
• Status: Terminated
• Phase: Phase 2
• Start date: November 3, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: April 2022
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 133
• Est. completion date: May 31, 2021
• Est. primary completion date: March 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• BI 764198
BI 764198
• Placebo
Placebo

Locations

Country	Name	City	State
Brazil	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	Sao Jose do Rio Preto
Chile	Hospital Padre Alberto Hurtado	Santiago
Chile	Hospital Carlos Van Buren	Valparaiso
Mexico	Hospital Cardiologica Aguascalientes	Aguascalientes
Mexico	Hospital General de Culiacán "Dr. Bernardo J. Gastellum"	Culiacán
Mexico	Hospital Universitario Dr Jose Eleuterio Gonzalez	Monterrey
Puerto Rico	Hospital Auxilio Mutuo	Hato Rey
Puerto Rico	Hospital Municipal de San Juan	Rio Piedras
Spain	Hospital A Coruña	A Coruña
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Infanta Leonor	Madrid
Spain	Hospital Son Espases	Palma de Mallorca
United States	Rapides Regional Medical Center	Alexandria	Louisiana
United States	St. Elizabeth's Medical Center	Boston	Massachusetts
United States	Providence Regional Medical Center	Everett	Washington
United States	Newton-Wellesley Hospital	Newton	Massachusetts
United States	University of California Irvine	Orange	California
United States	MultiCare Tacoma General Hospital	Tacoma	Washington
United States	Mercy Health St. Vincent Medical Center	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Brazil,  Chile,  Mexico,  Puerto Rico,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Patients Alive and Discharged Free of Oxygen Use	Percentage of patients alive and discharged free of oxygen use is presented. One patient had no creatinine at baseline value and was therefore excluded from the statistical analysis (N=128).	At Day 29
Secondary	Percentage of Patients With Occurrence of Any Component of Composite: In-hospital Mortality or Intensive Care Unit (ICU) Admission or Mechanical Ventilation	Percentage of patients with occurrence of any component of composite: In-hospital mortality or intensive care unit (ICU) admission or mechanical ventilation is presented.; Efficacy endpoint meets when a patient has occurrence of any component of composite: In-hospital mortality or intensive care unit (ICU) admission or mechanical ventilation at Day 29.; One patient had no creatinine at baseline value and was therefore excluded from the statistical analysis (N=128).	At Day 29
Secondary	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	Meets when improvement of at least 2 points on World Health Organization (WHO) Clinical Progression Scale (CPS), discharge from hospital, fit for discharge (score 0, 1, 2, 3 on CPS), whichever comes first.; WHO CPS: 0. Uninfected; no viral RNA detected; 1. Asymptomatic; viral RNA detected; 2. Symptomatic; independent; 3. Symptomatic; assistance needed; 4. Hospitalised; no oxygen therapy; 5. Hospitalised; oxygen by mask or nasal prongs; 6. Hospitalised; oxygen by non-invasive ventilation or high flow; 7. Intubation + mechanical ventilation, partial pressure of oxygen/fraction of inspired oxygen (pO2/FiO2) =150 or oxygen saturation/FiO2 (SpO2/FiO2) =200; 8. Mechanical ventilation pO2/FiO2 <150 (SpO2/FiO2 <200) or vasopressors; 9. Mechanical ventilation pO2/FiO2 <150 + vasopressors, dialysis, extracorporeal membrane oxygenation (ECMO); 10. Death Only patients with event were analysed. One patient had no creatinine at baseline value, therefore excluded from statistical analysis (N=128).	Up to Day 29
Secondary	Number of Ventilator Free Days	Number of ventilator free days by Day 29 is presented. One patient had no creatinine at baseline value and was therefore excluded from the statistical analysis (N=128).	Up to Day 29
Secondary	Percentage of Mortality at Day 15, 29, 60 and 90	Percentage of mortality is presented. One patient had no creatinine at baseline value and was therefore excluded from the statistical analysis (N=128).	At Day 15, 29, 60 and 90

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