Senicapoc in COVID-19 Patients With Severe Respiratory Insufficiency (COVIPOC)

University of Aarhus

Status and phase: Unknown; Phase 2

Conditions: COVID; ARDS, Human

Treatments: Drug: Senicapoc

Study type: Interventional

Funder types: Other

Identifiers

NCT04594668

2020-001420-34

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

46 participants in 2 patient groups

Standard treatment

No Intervention group

Description:

Standard intensive care

Senicapoc

Active Comparator group

Description:

Senicapoc

Treatment:

Drug: Senicapoc