Senicapoc in COVID-19 Patients With Severe Respiratory Insufficiency

NCT ID: NCT04594668

Last Updated: 2020-10-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-24
• Study Completion Date: 2021-12-31

Brief 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. 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.

Conditions

ARDS, Human; COVID

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard treatment

Standard intensive care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Senicapoc

Senicapoc

Group Type: ACTIVE_COMPARATOR

Senicapoc

Intervention Type: DRUG

The intervention will consist of 50 mg enteral senicapoc administered as soon as possible after randomization and again after 24 hours

Interventions

Senicapoc

The intervention will consist of 50 mg enteral senicapoc administered as soon as possible after randomization and again after 24 hours

Intervention Type: DRUG

Other Intervention Names

ICA-17043

Eligibility Criteria

Inclusion Criteria

• COVID-19 positive
• Age ≥18 years
• Respiratory insufficiency
• ICU admission

Exclusion Criteria

• 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
• Inability to take enteral medication
• More than 24 hours since ICU admission
• Limitations of care
• Anticipated death within 24 hours

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

Odense University Hospital

OTHER

Sponsor Role: collaborator

Aalborg University Hospital

OTHER

Sponsor Role: collaborator

Hvidovre University Hospital

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steffen Christensen, MD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Thomas Strøm, MD

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Bodil S Rasmussen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Aalborg University Hospital

Klaus T Kristiansen, MD

Role: PRINCIPAL_INVESTIGATOR

Hvidovre University Hospital

Asger Granfeldt, MD, PhD

Role: STUDY_CHAIR

Aarhus University Hospital

Locations

Aalborg University Hospital

Aalborg, , Denmark

Site Status: RECRUITING

Aarhus University Hospital

Aarhus, , Denmark

Site Status: RECRUITING

Hvidovre Hospital

Hvidovre, , Denmark

Site Status: RECRUITING

Odense University Hospital

Odense, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Ulf Simonsen, MD, PhD

Role: CONTACT

us@biomed.au.dk

+4560202613

Asger Granfeldt, MD, PhD

Role: CONTACT

covipoc@clin.au.dk

Facility Contacts

Bodil S Rasmussen, MD, PhD

Role: primary

Steffen Christensen, MD, PhD

Role: primary

Klaus T Kristiansen, MD

Role: primary

Thomas Strøm, MD

Role: primary

Other Identifiers

2020-001420-34

Identifier Type: -

Identifier Source: org_study_id