Treatment with Omega-3 polyunsaturated fatty acids in COVID-19 patients. A single-blind, randomized, placebo-controlled feasibility study.

Resolving inflammatory storm in COVID-19 patients by Omega-3 polyunsaturated fatty acids. - A single-blind, randomized, placebo-controlled feasibility study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002293-28-SE

Enrollment

Registered

2020-05-13

Start date

2020-05-29

Completion date

Unknown

Last updated

2021-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS-COV-2 Infection MedDRA version: 23.0 Level: LLT Classification code 10084272 Term: SARS-CoV-2 infection System Organ Class: 100000004862

Interventions

Trade Name: Omegaven Product Name: Omegaven Pharmaceutical Form: Emulsion for infusion Other descriptive name: HIGHLY REFINED FISH OIL Pharmaceutical form of the placebo: Infusion Route of administrat

Eligibility

Sex/Gender

All

Inclusion criteria

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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

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
Main Objective: To establish the effects of omega-3 fatty acids (Omegaven®) on inflammatory biomarkers in COVID-19 patients compared to placebo.;Secondary Objective: To establish if Omegaven® increases omega-3 index and proresolving mediators. To establish the feasibility of the study protocol. ;Primary end point(s): Changes in a panel of inflammatory biomarkers measured in blood samples, urine samples and released from ex vivo stimulated leukocytes after 5 days of treatment.;Timepoint(s) of evaluation of this end point: After 5 Days of treatment.	—

Measure

Time frame

Main Objective: To establish the effects of omega-3 fatty acids (Omegaven®) on inflammatory biomarkers in COVID-19 patients compared to placebo.;Secondary Objective: To establish if Omegaven® increases omega-3 index and proresolving mediators. To establish the feasibility of the study protocol. ;Primary end point(s): Changes in a panel of inflammatory biomarkers measured in blood samples, urine samples and released from ex vivo stimulated leukocytes after 5 days of treatment.;Timepoint(s) of evaluation of this end point: After 5 Days of treatment.

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Secondary

Measure	Time frame
Secondary end point(s): 1. Changes in proresolving mediators after 5 days of treatment 2. Changes in omega-3 index in the erythrocyte fraction after 5 days of treatment 3. Changes in cardiac biomarkers (Troponin, NTproBNP) after 5 days of treatment 4. Changes in biomarkers of organ damage (LD, creatinine) after 5 days of treatment 5. Changes in thrombosis and coagulation parameters (platelet count, coagulation) after 5 days of treatment 6. Changes in infectious load (PCT, SARS-CoV2-RNAemia, antibodies) after 5 days of treatment 7. Effects on clinical parameters (NEWS2, oxygen need, length of hospital stay, ICU need, complications, mortality) during hospitalization ;Timepoint(s) of evaluation of this end point: Endpoints 1-6: After 5 Days of treatment. Endpoint 7: During hospitalization.	—

Measure

Time frame

Secondary end point(s): 1. Changes in proresolving mediators after 5 days of treatment 2. Changes in omega-3 index in the erythrocyte fraction after 5 days of treatment 3. Changes in cardiac biomarkers (Troponin, NTproBNP) after 5 days of treatment 4. Changes in biomarkers of organ damage (LD, creatinine) after 5 days of treatment 5. Changes in thrombosis and coagulation parameters (platelet count, coagulation) after 5 days of treatment 6. Changes in infectious load (PCT, SARS-CoV2-RNAemia, antibodies) after 5 days of treatment 7. Effects on clinical parameters (NEWS2, oxygen need, length of hospital stay, ICU need, complications, mortality) during hospitalization ;Timepoint(s) of evaluation of this end point: Endpoints 1-6: After 5 Days of treatment. Endpoint 7: During hospitalization.

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Countries

Sweden

Contacts

Public ContactCo-ordinating investigator

Karolinska University Hospital

magnus.back@ki.se+46707677470

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 24, 2026