COVID-19
Conditions
Keywords
Inflammatory Storm, COVID-19 infection, Omega-3 fatty acids, Inflammatory biomarkers, Omega-3 index
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.
Interventions
DRUGOmegaven®
A highly refined fish oil in an emulsion for infusion with purified egg phosphatides and glycerol.
DRUGSodium chloride
intravenously administered 2 mL/kg/day
Sponsors
Karolinska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Provision of signed informed consent prior to any study specific procedures. 2. Female and male patients ≥18 years of age. 3. COVID-19 positive or typical CT image of COVID-19 infection. 4. Clinical status requiring hospitalization.
Exclusion criteria
1. According to Omegaven® contraindications (serious bleeding disorders, acute life-threatening condition, including acute shock, acute myocardial infarction, acute stroke, acute emboli, and coma). 2. Known hypersensitivity to Omegaven® or any of the ingredients. 3. Participation in any clinical research study evaluating an investigational medicinal product (IMP) within 3 months prior to screening. 4. Pregnancy and breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in inflammatory biomarkers | 5 days | white blood cell counts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in proresolving mediators | 5 days | lipidomics |
| 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 coagulation parameters | 5 days | fibrinogen |
| 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 markers of infection | 5 days | procalcitonin concentrations |
Countries
Sweden
Outcome results
None listed