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

Resolving Inflammatory Storm in COVID-19 Patients by Omega-3 Polyunsaturated Fatty Acids - A Single-blind, Randomized, Placebo-controlled Feasibility Study

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: Omegaven®; Drug: Sodium chloride

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 2

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Södersjukhuset
  • Stockholm, Sweden
    • Karolinska Universitetssjuhuset

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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	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	Drug: Sodium chloride; intravenously administered 2 mL/kg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in proresolving mediators	lipidomics	5 days
Changes in fatty acids in the erythrocyte fraction	fatty acid profile	5 days
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

Collaborators and Investigators

• Sponsor: Karolinska University Hospital
• Investigators: Principal Investigator: Magnus Bäck, Professor, Karolinska University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2020
• Primary Completion (Actual): January 5, 2021
• Study Completion (Actual): July 7, 2021

Study Registration Dates

• First Submitted: June 12, 2020
• First Submitted That Met QC Criteria: November 27, 2020
• First Posted (Actual): December 1, 2020

Study Record Updates

• Last Update Posted (Actual): January 5, 2022
• Last Update Submitted That Met QC Criteria: January 4, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Omega-3 fatty acids; COVID-19 infection; Inflammatory Storm; Inflammatory biomarkers; Omega-3 index
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2020-002293-28

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individual participant data that underlie the results reported will be shared, after deidentification, with researchers who provide a methodologically sound proposal.
• IPD Sharing Time Frame: Beginning 9 months following article publication and finishing 36 months following article publication.
• IPD Sharing Access Criteria: Study protocol will be published. Investigators interested in data should contact the principal investigator.
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No