A Phase 2 interventional study of Omegaven® and Sodium chloride in COVID-19, sponsored by Karolinska University Hospital. Completed at 2 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-05.
Sponsored by Karolinska University Hospital · Phase 2, Interventional, and Treatment
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 23 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Karolinska University Hospital is the lead sponsor of 275 studies on the registry; 54 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: Omegaven®
2 mL/kg/day) once daily for 5 days
Drug: Sodium chloride
A highly refined fish oil in an emulsion for infusion with purified egg phosphatides and glycerol.
intravenously administered 2 mL/kg/day
Changes in inflammatory biomarkers
white blood cell counts
Time frame: 5 days
Changes in inflammatory biomarkers
CRP
Time frame: 5 days
Changes in inflammatory biomarkers
lipidomic profiling
Time frame: 5 days
Changes in inflammatory biomarkers
cytokines
Time frame: 5 days
Changes in inflammatory biomarkers
metabolomic profiling
Time frame: 5 days
Changes in proresolving mediators
lipidomics
Time frame: 5 days
Changes in fatty acids in the erythrocyte fraction
fatty acid profile
Time frame: 5 days
Changes in cardiac biomarkers
Troponin, NTproBNP
Time frame: 5 days
Changes in biomarkers of organ damage
LD, creatinine
Time frame: 5 days
Changes in thrombosis parameters
platelet count, D-dimer,
Time frame: 5 days
Changes in coagulation parameters
fibrinogen
Time frame: 5 days
Changes in markers of infection
procalcitonin concentrations
Time frame: 5 days
Changes in infection load
SARS-CoV2-RNAemia
Time frame: 5 days
Changes in clinical parameters
National Early Warning Score (NEWS2)
Time frame: through study completion, on average 10 days
Length of hospital stay
Days of hospital stay
Time frame: through study completion, on average 10 days
Complications
ICU need, mortality
Time frame: through study completion, on average 10 days
Plan to share: Yes — Individual participant data that underlie the results reported will be shared, after deidentification, with researchers who provide a methodologically sound proposal.
Supporting information: Study protocol
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Karolinska University Hospital