ARDS, HumanPhase 2COVIPOCNCT04594668
Senicapoc in COVID-19 Patients With Severe Respiratory Insufficiency
A Phase 2 study testing Senicapoc in people with ARDS, Human and COVID, run by University of Aarhus at 4 sites in Denmark.
Trial summary
SARS-CoV-2, one of a family of human coronaviruses, was initially identified in December 2019 in Wuhan city. This new coronavirus causes a disease that has now been named COVID-19. The virus has subsequently spread throughout the world and was declared a pandemic by the World Health Organisation on 11th March 2020. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS, Human, COVID
- What is being tested?
- Senicapoc
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 4 sitesDenmark
- Study dates
- 24 Apr 2020to 31 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COVID-19 positive
- Age ≥18 years
- Respiratory insufficiency
- ICU admission
Who cannot join
- Severe heart failure (ejection fraction < 30%)
- Severe renal insufficiency (eGFR < 30 mL/min/1.73m2)
- Severe hemodynamic instability (noradrenalin dose > 0.3 μg/kg/min)
- Prior enrollment in the trial
- Pregnancy
- Allergy to senicapoc
Show all 10Show fewer
- Inability to take enteral medication
- More than 24 hours since ICU admission
- Limitations of care
- Anticipated death within 24 hours
Trial locations and contacts
4 sites in 1 country.
Asger Granfeldt, MD, PhD contact
Denmark4 sites, 4 recruiting
- Recruiting
Aalborg University Hospital
Aalborg, 9000
Bodil S Rasmussen, MD, PhD
- Recruiting
Aarhus University Hospital
Aarhus, 8000
Steffen Christensen, MD, PhD
- Recruiting
Hvidovre Hospital
Hvidovre, 2650
Klaus T Kristiansen, MD
- Recruiting
Odense University Hospital
Odense, 5000
Thomas Strøm, MD
About this study
Official title: Senicapoc in COVID-19 Patients With Severe Respiratory Insufficiency - A Randomized, Open-Label, Phase II Trial
SARS-CoV-2, one of a family of human coronaviruses, was initially identified in December 2019 in Wuhan city. This new coronavirus causes a disease that has now been named COVID-19. The virus has subsequently spread throughout the world and was declared a pandemic by the World Health Organisation on 11th March 2020. As of April 1, 2020, there are 874.081 numbers of confirmed cases with 43.290 fatalities. There is no approved therapy for COVID-19 and the current standard of care is supportive treatment.
Key markers implying a fatal outcome are acute respiratory distress syndrome (ARDS)-like disease with pronounced dyspnea, hypoxia and radiological changes in the lung. Senicapoc improves oxygenation and reduces fluid retention, inflammation, and bleeding in the lungs of mice with ARDS-like disease. In cells, there is an antiviral effect of senicapoc.
Read the detailed description
The investigators discovered that in an animal model with a knockout of a potassium channel with intermediate conductance (KCa3.1), the knockout protected against lung damage and accumulation of liquid in the lung. In subsequent studies, the investigators have developed a mouse model showing that genetic deletion of the KCa3.1 channels and senicapoc, a blocker of KCa3.1 channels, protects against the accumulation of liquid in the lung. Moreover, senicapoc treatment possesses anti-inflammatory effects illustrated as lower leukocyte accumulation inside the lungs after injury. Importantly, it also increases the FiO2/PaO2 ratio (ratio of inhaled to blood oxygen), hence preserving lung function in mice with an ARDS-like disease. In addition, there is evidence that senicapoc has antiviral properties. Aarhus University has patented senicapoc for use in the treatment of acute respiratory disease. In this case, respiratory disease is caused by an infection with a coronavirus. Senicapoc has been developed for the treatment of sickle cell disease and has been administered to 500 patients without observation of major treatment-related adverse effects.
- Conditions
- ARDS, Human, COVID
- Being tested
- Senicapoc
- Keywords
- senicapoc, severe acute respiratory distress syndrome, SARS-COV2, corona virus infection
- Medical subject headings
- Respiratory Distress Syndrome, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SenicapocDrug
Also called ICA-17043
The intervention will consist of 50 mg enteral senicapoc administered as soon as possible after randomization and again after 24 hours
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment | No intervention | Standard intensive care |
| Senicapoc | Active comparator | Senicapoc Receives: Drug: Senicapoc |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaO2/FiO2 ratio
The PaO2/FiO2 ratio will be calculated based on the arterial gas closest to the time-point of Day 3 after randomization
Measured: Day 3
Secondary outcomes (2)
Ventilator-free days
Ventilator-free days will be defined as the number of days (or proportion of days) within the first 28 days after randomization where the patient is alive and not on invasive mechanical ventilation
Measured: Day 28
Mortality
Assessment of mortality is considered a core outcome for trials within acute respiratory failure
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start24 Apr 2020
- Primary completion24 Apr 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS, HumanStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Model description
- A Randomized, Open-Label, Phase II Trial
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Odense University Hospital, Aalborg University Hospital, Hvidovre University Hospital
- Responsible party
- Sponsor
- Investigators
- Steffen Christensen, MD, Principal investigator, Aarhus University HospitalThomas Strøm, MD, Principal investigator, Odense University HospitalBodil S Rasmussen, MD, PhD, Principal investigator, Aalborg University HospitalKlaus T Kristiansen, MD, Principal investigator, Hvidovre University HospitalAsger Granfeldt, MD, PhD, Study chair, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04594668
- Sponsor's protocol ID
- 2020-001420-34
- Acronym
- COVIPOC
- Status last verified
- Apr 2020
- First submitted
- 7 Oct 2020
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing plan: Individual de-identified participant data (including data dictionaries) will be shared following the publication of the primary and secondary endpoints as outlined in this protocol. Data to be shared included de-identified data points in published, peer-reviewed articles. Additional, related documents will also be available (study protocol, informed consent form, statistical analysis plan).
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Senicapoc in COVID-19 Patients With Severe Respiratory Insufficiency - A Randomized, Open-Label, Phase II Trial
- ClinicalTrials.gov ID
- NCT04594668
- Acronym / sponsor ID
- COVIPOC / 2020-001420-34
- Conditions
- ARDS, Human, COVID
- Keywords
- senicapoc, severe acute respiratory distress syndrome, SARS-COV2, corona virus infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Odense University Hospital, Aalborg University Hospital, Hvidovre University Hospital
- Study start
- 24 Apr 2020 (actual)
- Primary completion
- 24 Apr 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
SARS-CoV-2, one of a family of human coronaviruses, was initially identified in December 2019 in Wuhan city. This new coronavirus causes a disease that has now been named COVID-19. The virus has subsequently spread throughout the world and was declared a pandemic by the World Health Organisation on 11th March 2020. As of April 1, 2020, there are 874.081 numbers of confirmed cases with 43.290 fatalities. There is no approved therapy for COVID-19 and the current standard of care is supportive treatment.
Key markers implying a fatal outcome are acute respiratory distress syndrome (ARDS)-like disease with pronounced dyspnea, hypoxia and radiological changes in the lung. Senicapoc improves oxygenation and reduces fluid retention, inflammation, and bleeding in the lungs of mice with ARDS-like disease. In cells, there is an antiviral effect of senicapoc.
Detailed description
The investigators discovered that in an animal model with a knockout of a potassium channel with intermediate conductance (KCa3.1), the knockout protected against lung damage and accumulation of liquid in the lung. In subsequent studies, the investigators have developed a mouse model showing that genetic deletion of the KCa3.1 channels and senicapoc, a blocker of KCa3.1 channels, protects against the accumulation of liquid in the lung. Moreover, senicapoc treatment possesses anti-inflammatory effects illustrated as lower leukocyte accumulation inside the lungs after injury. Importantly, it also increases the FiO2/PaO2 ratio (ratio of inhaled to blood oxygen), hence preserving lung function in mice with an ARDS-like disease. In addition, there is evidence that senicapoc has antiviral properties. Aarhus University has patented senicapoc for use in the treatment of acute respiratory disease. In this case, respiratory disease is caused by an infection with a coronavirus. Senicapoc has been developed for the treatment of sickle cell disease and has been administered to 500 patients without observation of major treatment-related adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Randomized, Open-Label, Phase II Trial
| Arm | Type | Receives |
|---|---|---|
| Standard treatment | No intervention | –Standard intensive care |
| Senicapoc | Active comparator | Drug: SenicapocSenicapoc |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- COVID-19 positive
- Age ≥18 years
- Respiratory insufficiency
- ICU admission
Key exclusion criteria (10 listed)
- Severe heart failure (ejection fraction < 30%)
- Severe renal insufficiency (eGFR < 30 mL/min/1.73m2)
- Severe hemodynamic instability (noradrenalin dose > 0.3 μg/kg/min)
- Prior enrollment in the trial
- Pregnancy
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 |
|---|---|---|
| SenicapocAlso: ICA-17043The intervention will consist of 50 mg enteral senicapoc administered as soon as possible after randomization and again after 24 hours | Drug | Senicapoc |
Primary outcome
PaO2/FiO2 ratio
Time frame: Day 3
The PaO2/FiO2 ratio will be calculated based on the arterial gas closest to the time-point of Day 3 after randomization
2 secondary outcomes
Ventilator-free days
Time frame: Day 28
Mortality
Time frame: Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Individual participant dataSharing planned: Yes. Data sharing plan: Individual de-identified participant data (including data dictionaries) will be shared following the publication of the primary and secondary endpoints as outlined in this protocol. Data to be shared included de-identified data points in published, peer-reviewed articles. Additional, related documents will also be available (study protocol, informed consent form, statistical analysis plan).
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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.
Asger Granfeldt, MD, PhD contact
Steffen Christensen, MD principal investigator
Aarhus University Hospital
Thomas Strøm, MD principal investigator
Odense University Hospital
Bodil S Rasmussen, MD, PhD principal investigator
Aalborg University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Senicapoc in people with ARDS, Human and COVID, run by University of Aarhus at 4 sites in Denmark.
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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ulf Simonsen, MD, PhD (+4560202613, us@biomed.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PaO2/FiO2 ratio (time frame: Day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2020.