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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omega | Active Comparator | 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) | Placebo Comparator | 2 mL/kg/day) once daily for 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omegaven® | Drug | A highly refined fish oil in an emulsion for infusion with purified egg phosphatides and glycerol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in inflammatory biomarkers | white blood cell counts | 5 days |
| Changes in inflammatory biomarkers | CRP | 5 days |
| Changes in inflammatory biomarkers | lipidomic profiling | 5 days |
| Changes in inflammatory biomarkers | cytokines | 5 days |
| Changes in inflammatory biomarkers | metabolomic profiling | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in proresolving mediators | lipidomics | 5 days |
| Changes in fatty acids in the erythrocyte fraction | fatty acid profile | 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Magnus Bäck, Professor | Karolinska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Universitetssjuhuset | Stockholm | Sweden | ||||
| Södersjukhuset |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33505321 | Derived | Arnardottir H, Pawelzik SC, Ohlund Wistbacka U, Artiach G, Hofmann R, Reinholdsson I, Braunschweig F, Tornvall P, Religa D, Back M. Stimulating the Resolution of Inflammation Through Omega-3 Polyunsaturated Fatty Acids in COVID-19: Rationale for the COVID-Omega-F Trial. Front Physiol. 2021 Jan 11;11:624657. doi: 10.3389/fphys.2020.624657. eCollection 2020. |
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Individual participant data that underlie the results reported will be shared, after deidentification, with researchers who provide a methodologically sound proposal.
Beginning 9 months following article publication and finishing 36 months following article publication.
Study protocol will be published. Investigators interested in data should contact the principal investigator.
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C568345 | fish oil triglycerides |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Sodium chloride | Drug | intravenously administered 2 mL/kg/day |
|
| Changes in cardiac biomarkers | Troponin, NTproBNP | 5 days |
| Changes in biomarkers of organ damage | LD, creatinine | 5 days |
| Changes in thrombosis parameters | platelet count, D-dimer, | 5 days |
| Changes in coagulation parameters | fibrinogen | 5 days |
| Changes in markers of infection | procalcitonin concentrations | 5 days |
| Changes in infection load | SARS-CoV2-RNAemia | 5 days |
| Changes in clinical parameters | National Early Warning Score (NEWS2) | through study completion, on average 10 days |
| Length of hospital stay | Days of hospital stay | through study completion, on average 10 days |
| Complications | ICU need, mortality | through study completion, on average 10 days |
| Stockholm |
| Sweden |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D017670 |
| Sodium Compounds |