Omegaven®
DrugA highly refined fish oil in an emulsion for infusion with purified egg phosphatides and glycerol.
Completed
NCT Number: NCT04647604
Resolving Inflammatory Storm in COVID-19 Patients by Omega-3 Polyunsaturated Fatty Acids -
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Karolinska Universitetssjuhuset, Stockholm, Sweden
Loading trial locations.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Sodium Chloride
Drugintravenously administered 2 mL/kg/day
Primary outcomes
-
Changes in inflammatory biomarkers
Time frame: 5 days
white blood cell counts
-
Changes in inflammatory biomarkers
Time frame: 5 days
CRP
-
Changes in inflammatory biomarkers
Time frame: 5 days
lipidomic profiling
-
Changes in inflammatory biomarkers
Time frame: 5 days
cytokines
-
Changes in inflammatory biomarkers
Time frame: 5 days
metabolomic profiling
Secondary outcomes
-
Changes in proresolving mediators
Time frame: 5 days
lipidomics
-
Changes in fatty acids in the erythrocyte fraction
Time frame: 5 days
fatty acid profile
-
Changes in cardiac biomarkers
Time frame: 5 days
Troponin, NTproBNP
-
Changes in biomarkers of organ damage
Time frame: 5 days
LD, creatinine
-
Changes in thrombosis parameters
Time frame: 5 days
platelet count, D-dimer,
-
Changes in coagulation parameters
Time frame: 5 days
fibrinogen
-
Changes in markers of infection
Time frame: 5 days
procalcitonin concentrations
-
Changes in infection load
Time frame: 5 days
SARS-CoV2-RNAemia
-
Changes in clinical parameters
Time frame: through study completion, on average 10 days
National Early Warning Score (NEWS2)
-
Length of hospital stay
Time frame: through study completion, on average 10 days
Days of hospital stay
-
Complications
Time frame: through study completion, on average 10 days
ICU need, mortality
Sponsors and collaborators
Lead sponsor
Karolinska University Hospital
Other
Registry information
Official study title
Resolving Inflammatory Storm in COVID-19 Patients by Omega-3 Polyunsaturated Fatty Acids - A Single-blind, Randomized, Placebo-controlled Feasibility Study
Important dates
- Study start
- 2020
- Primary completion
- 2021
- Study completion
- 2021
- First posted
- Dec 1, 2020
- Registry last updated
- Jan 5, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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