Resolving Inflammatory Storm in COVID-19 Patients by Omega-3 Polyunsaturated Fatty Acids -
- Registration Number
- NCT04647604
- Lead Sponsor
- Karolinska University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Omega Omegaven® 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 Sodium chloride (NaCl) Sodium chloride 2 mL/kg/day) once daily for 5 days
- Primary Outcome Measures
Name Time Method Changes in inflammatory biomarkers 5 days metabolomic profiling
- Secondary Outcome Measures
Name Time Method Changes in thrombosis parameters 5 days platelet count, D-dimer,
Changes in infection load 5 days SARS-CoV2-RNAemia
Changes in clinical parameters through study completion, on average 10 days National Early Warning Score (NEWS2)
Length of hospital stay through study completion, on average 10 days Days of hospital stay
Complications through study completion, on average 10 days ICU need, mortality
Changes in fatty acids in the erythrocyte fraction 5 days fatty acid profile
Changes in cardiac biomarkers 5 days Troponin, NTproBNP
Changes in biomarkers of organ damage 5 days LD, creatinine
Changes in proresolving mediators 5 days lipidomics
Changes in markers of infection 5 days procalcitonin concentrations
Changes in coagulation parameters 5 days fibrinogen
Trial Locations
- Locations (2)
Södersjukhuset
🇸🇪Stockholm, Sweden
Karolinska Universitetssjuhuset
🇸🇪Stockholm, Sweden