Clinical trial NCT04647604: Resolving Inflammatory Storm in COVID-19 Patients by Omega-3 Polyunsaturated Fatty Acids -
Official title: Resolving Inflammatory Storm in COVID-19 Patients by Omega-3 Polyunsaturated Fatty Acids - A Single-blind, Randomized, Placebo-controlled Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Keywords: Inflammatory Storm
COVID-19 infection
Omega-3 fatty acids
Inflammatory biomarkers
Omega-3 index
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2020-12-01
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

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.

Primary outcomes:
measure: Changes in inflammatory biomarkers
timeFrame: 5 days
measure: Changes in inflammatory biomarkers
timeFrame: 5 days
measure: Changes in inflammatory biomarkers
timeFrame: 5 days
measure: Changes in inflammatory biomarkers
timeFrame: 5 days
measure: Changes in inflammatory biomarkers
timeFrame: 5 days
Secondary outcomes:
measure: Changes in proresolving mediators
timeFrame: 5 days
measure: Changes in fatty acids in the erythrocyte fraction
timeFrame: 5 days
measure: Changes in cardiac biomarkers
timeFrame: 5 days
measure: Changes in biomarkers of organ damage
timeFrame: 5 days
measure: Changes in thrombosis parameters
timeFrame: 5 days
measure: Changes in coagulation parameters
timeFrame: 5 days
measure: Changes in markers of infection
timeFrame: 5 days
measure: Changes in infection load
timeFrame: 5 days
measure: Changes in clinical parameters
timeFrame: through study completion, on average 10 days
measure: Length of hospital stay
timeFrame: through study completion, on average 10 days
measure: Complications
timeFrame: through study completion, on average 10 days
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjuhuset
city: Stockholm
country: Sweden
facility: Södersjukhuset
Study officials:
affiliation: Karolinska University Hospital
name: Magnus Bäck, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.