Senicapoc in COVID-19 Patients With Severe Respiratory Insufficiency
COVIPOC
1 other identifier
interventional
46
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2020
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 24, 2020
CompletedFirst Submitted
Initial submission to the registry
October 7, 2020
CompletedFirst Posted
Study publicly available on registry
October 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 24, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedOctober 20, 2020
April 1, 2020
1 year
October 7, 2020
October 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Day 3
Secondary Outcomes (2)
Ventilator-free days
Day 28
Mortality
Day 28
Other Outcomes (5)
Vasopressor-free days
Day 28
Sequential Organ Failure Assessment (SOFA)-score
Day 1, 2, 3, and 5
Need for renal replacement therapy
Day 28
- +2 more other outcomes
Study Arms (2)
Standard treatment
NO INTERVENTIONStandard intensive care
Senicapoc
ACTIVE COMPARATORSenicapoc
Interventions
The intervention will consist of 50 mg enteral senicapoc administered as soon as possible after randomization and again after 24 hours
Eligibility Criteria
You may qualify if:
- COVID-19 positive
- Age ≥18 years
- Respiratory insufficiency
- ICU admission
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Aarhus University Hospitalcollaborator
- Odense University Hospitalcollaborator
- Aalborg University Hospitalcollaborator
- Hvidovre University Hospitalcollaborator
Study Sites (4)
Aalborg University Hospital
Aalborg, 9000, Denmark
Aarhus University Hospital
Aarhus, 8000, Denmark
Hvidovre Hospital
Hvidovre, 2650, Denmark
Odense University Hospital
Odense, 5000, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steffen Christensen, MD
Aarhus University Hospital
- PRINCIPAL INVESTIGATOR
Thomas Strøm, MD
Odense University Hospital
- PRINCIPAL INVESTIGATOR
Bodil S Rasmussen, MD, PhD
Aalborg University Hospital
- PRINCIPAL INVESTIGATOR
Klaus T Kristiansen, MD
Hvidovre University Hospital
- STUDY CHAIR
Asger Granfeldt, MD, PhD
Aarhus University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Senicapoc-treated patients compared to standard treatment
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2020
First Posted
October 20, 2020
Study Start
April 24, 2020
Primary Completion
April 24, 2021
Study Completion
December 31, 2021
Last Updated
October 20, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will become available following publication with no planned end date.
- Access Criteria
- Access to the data sharing will be given to researchers who provide a methodologically sound proposal for any type of analysis and requires IRB/Ethics approval (if applicable). Proposal should be addressed to us@biomed.au.dk
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).