Resolving Inflammatory Storm in COVID-19 Patients by Omega-3 Polyunsaturated Fatty Acids -
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ClinicalTrials.gov Identifier: NCT04647604 |
Recruitment Status :
Completed
First Posted : December 1, 2020
Last Update Posted : January 5, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID-19 | Drug: Omegaven® Drug: Sodium chloride | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 23 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Resolving Inflammatory Storm in COVID-19 Patients by Omega-3 Polyunsaturated Fatty Acids - A Single-blind, Randomized, Placebo-controlled Feasibility Study |
Actual Study Start Date : | June 23, 2020 |
Actual Primary Completion Date : | January 5, 2021 |
Actual Study Completion Date : | July 7, 2021 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 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
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Drug: Omegaven®
A highly refined fish oil in an emulsion for infusion with purified egg phosphatides and glycerol. |
Placebo Comparator: Sodium chloride (NaCl)
2 mL/kg/day) once daily for 5 days
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Drug: Sodium chloride
intravenously administered 2 mL/kg/day |
- 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
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04647604
Sweden | |
Karolinska Universitetssjuhuset | |
Stockholm, Sweden | |
Södersjukhuset | |
Stockholm, Sweden |
Principal Investigator: | Magnus Bäck, Professor | Karolinska University Hospital |
Responsible Party: | Magnus Bäck, Professor of Cardiology, Karolinska University Hospital |
ClinicalTrials.gov Identifier: | NCT04647604 |
Other Study ID Numbers: |
2020-002293-28 |
First Posted: | December 1, 2020 Key Record Dates |
Last Update Posted: | January 5, 2022 |
Last Verified: | January 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Individual participant data that underlie the results reported will be shared, after deidentification, with researchers who provide a methodologically sound proposal. |
Supporting Materials: |
Study Protocol |
Time Frame: | Beginning 9 months following article publication and finishing 36 months following article publication. |
Access Criteria: | Study protocol will be published. Investigators interested in data should contact the principal investigator. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Inflammatory Storm COVID-19 infection Omega-3 fatty acids Inflammatory biomarkers Omega-3 index |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |