Resolving Inflammatory Storm in COVID-19 Patients by Omega-3 Polyunsaturated Fatty Acids -

Karolinska University Hospital

Status and phase: Completed; Phase 2

Conditions: COVID-19

Treatments: Drug: Sodium chloride; Drug: Omegaven®

Study type: Interventional

Funder types: Other

Identifiers

NCT04647604

2020-002293-28

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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23 participants in 2 patient groups, including a placebo group

Omega

Active Comparator group

Description:

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

Treatment:

Drug: Omegaven®

Sodium chloride (NaCl)

Placebo Comparator group

Description:

2 mL/kg/day) once daily for 5 days

Treatment:

Drug: Sodium chloride