Senicapoc in COVID-19 Patients With Severe Respiratory Insufficiency

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.

Conditions

• ARDS, Human
• COVID

Interventions

DRUG

Senicapoc

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

Sponsors & Collaborators

• Aarhus University Hospital

  collaborator OTHER

• Odense University Hospital

  collaborator OTHER

• Aalborg University Hospital

  collaborator OTHER

• Hvidovre University Hospital

  collaborator OTHER

• University of Aarhus

  lead OTHER

Principal Investigators

• Steffen Christensen, MD · Aarhus University Hospital

• Thomas Strøm, MD · Odense University Hospital

• Bodil S Rasmussen, MD, PhD · Aalborg University Hospital

• Klaus T Kristiansen, MD · Hvidovre University Hospital

• Asger Granfeldt, MD, PhD · Aarhus University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-04-24

Primary Completion

2021-04-24

Completion

2021-12-31

Countries

• Denmark

Study Locations