Senicapoc in COVID-19 Patients With Severe Respiratory Insufficiency

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Aarhus
• Collaborators: Aalborg University Hospital; Aarhus University Hospital; Hvidovre University Hospital; Odense University Hospital

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