COVID-19Phase 2NCT04604184
ACTION ON COVID-19: A Study to Test Whether BI 764198 Helps Lung Health of People Hospitalised With COVID-19
A Phase 2 study testing BI 764198 in people with COVID-19, run by Boehringer Ingelheim at 25 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- BI 764198
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 133 participants
- Where
- 25 sitesin 6 countries
- Study dates
- 3 Nov 2020to 31 May 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 12Show fewer
- 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
Trial locations and contacts
25 sites in 6 countries.
25 sites in 6 countries
United States7 sites
Rapides Regional Medical Center
Alexandria, Louisiana, 71301
St. Elizabeth's Medical Center
Boston, Massachusetts, 02135
Providence Regional Medical Center
Everett, Washington, 98201
Newton-Wellesley Hospital
Newton, Massachusetts, 02462
University of California Irvine
Orange, California, 92868
MultiCare Tacoma General Hospital
Tacoma, Washington, 98405
Mercy Health St. Vincent Medical Center
Toledo, Ohio, 43608
Spain6 sites
Hospital A Coruña
A Coruña, 15006
Hospital General Universitario de Alicante
Alicante, 03010
Hospital Universitario Infanta Leonor
Madrid, 28031
Hospital Clínico San Carlos
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Son Espases
Palma de Mallorca, 07120
Brazil5 sites
Hospital Luxemburgo
Belo Horizonte, 32380-490
IPECC - Instituto de Pesquisa Clínica de Campinas
Campinas, 13060-080
Hospital Ernesto Dornelles
Porto Alegre, 90160-092
Hospital Regional Hans Dieter Schmidt
Santa Catarina, 89227
Hospital de Base - Fac Med de Sao Jose do Rio Preto
São José do Rio Preto, 15090-000
Mexico3 sites
Hospital Cardiologica Aguascalientes
Aguascalientes, 20230
Hospital General de Culiacán "Dr. Bernardo J. Gastellum"
Culiacán, 80230
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, 64460
Chile2 sites
Hospital Padre Alberto Hurtado
Santiago, 8880465
Hospital Carlos Van Buren
Valparaíso, 2341131
Puerto Rico2 sites
Hospital Auxilio Mutuo
Hato Rey, 00919
Hospital Municipal de San Juan
Rio Piedras, 00936
About this study
Official title: BI 764198 Efficacy and Safety in Prevention/Progression of ARDS and ARDS-related Complications Secondary to COVID-19 (ACTION ON COVID-19)
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.
Read more
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.
- Conditions
- COVID-19
- Being tested
- BI 764198, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 764198Drug
BI 764198
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| BI 764198 treatment group | Experimental | Not described Receives: Drug: BI 764198 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At Day 29
Secondary outcomes (5)
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).
Measured: 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
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).
Measured: 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
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).
Measured: Up to Day 29
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).
Measured: Up to Day 29
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).
Measured: At Day 15, 29, 60 and 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start3 Nov 2020
- Primary completion24 Mar 2021
- Study completion31 May 2021
Why it stopped: Company decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04604184
- Sponsor's protocol ID
- 1434-0009
- Other IDs
- 2020-003211-96
- Status last verified
- Apr 2022
- First submitted
- 26 Oct 2020
- Last updated
- 11 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 37024277
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BI 764198 Efficacy and Safety in Prevention/Progression of ARDS and ARDS-related Complications Secondary to COVID-19 (ACTION ON COVID-19)
- ClinicalTrials.gov ID
- NCT04604184
- Acronym / sponsor ID
- 1434-0009
- Conditions
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company decision
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 24 Mar 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 27 Oct 2020 (actual)
- Results
- Posted 11 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 764198 treatment group | Experimental | Drug: BI 764198 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 764198BI 764198 | Drug | BI 764198 treatment group |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Percentage of Patients Alive and Free of Mechanical Ventilation
Time frame: At Day 29
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).
5 secondary outcomes
Percentage of Patients Alive and Discharged Free of Oxygen Use
Time frame: 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
Time frame: 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
Time frame: Up to Day 29
Number of Ventilator Free Days
Time frame: Up to Day 29
Percentage of Mortality at Day 15, 29, 60 and 90
Time frame: At Day 15, 29, 60 and 90
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37024277Ware 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BI 764198 in people with COVID-19, run by Boehringer Ingelheim at 25 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Spain, Brazil, Mexico, Chile and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients Alive and Free of Mechanical Ventilation (time frame: At Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04604184, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.