NCT04647604
Completed
Phase 2
Resolving Inflammatory Storm in COVID-19 Patients by Omega-3 Polyunsaturated Fatty Acids - A Single-blind, Randomized, Placebo-controlled Feasibility Study
Karolinska University Hospital2 sites in 1 country23 target enrollmentJune 23, 2020
Overview
- Phase
- Phase 2
- Intervention
- Omegaven®
- Conditions
- COVID-19
- Sponsor
- Karolinska University Hospital
- Enrollment
- 23
- Locations
- 2
- Primary Endpoint
- Changes in inflammatory biomarkers
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
A study on patients who are hospitalized and tested positive for COVID-19 or have a typical CT image of COVID-19 infection, to establish if omega-3 Polyunsaturated Fatty Acid (PUFA) supplementation by intravenous route is a possible treatment option in COVID-19 with minimal risks to the patients.
Investigators
Magnus Bäck
Professor of Cardiology
Karolinska University Hospital
Eligibility Criteria
Inclusion Criteria
- •Provision of signed informed consent prior to any study specific procedures.
- •Female and male patients ≥18 years of age.
- •COVID-19 positive or typical CT image of COVID-19 infection.
- •Clinical status requiring hospitalization.
Exclusion Criteria
- •According to Omegaven® contraindications (serious bleeding disorders, acute life-threatening condition, including acute shock, acute myocardial infarction, acute stroke, acute emboli, and coma).
- •Known hypersensitivity to Omegaven® or any of the ingredients.
- •Participation in any clinical research study evaluating an investigational medicinal product (IMP) within 3 months prior to screening.
- •Pregnancy and breastfeeding.
Arms & Interventions
Omega
Omegaven® (2 mL/kg/day, equivalent to 6 g Docosahexaenoic Acid (DHA)+Eicosapentaenoic Acid (EPA) in a 70 kg individual) once daily for 5 days
Intervention: Omegaven®
Sodium chloride (NaCl)
2 mL/kg/day) once daily for 5 days
Intervention: Sodium chloride
Outcomes
Primary Outcomes
Changes in inflammatory biomarkers
Time Frame: 5 days
metabolomic profiling
Secondary Outcomes
- Changes in thrombosis parameters(5 days)
- Changes in coagulation parameters(5 days)
- Changes in infection load(5 days)
- Changes in clinical parameters(through study completion, on average 10 days)
- Length of hospital stay(through study completion, on average 10 days)
- Complications(through study completion, on average 10 days)
- Changes in fatty acids in the erythrocyte fraction(5 days)
- Changes in cardiac biomarkers(5 days)
- Changes in biomarkers of organ damage(5 days)
- Changes in proresolving mediators(5 days)
- Changes in markers of infection(5 days)
Study Sites (2)
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