NCT04647604

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_2 covid19

Timeline
Completed

Started Jun 2020

Typical duration for phase_2 covid19

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2020

Completed
11 days until next milestone

Study Start

First participant enrolled

June 23, 2020

Completed
5 months until next milestone

First Posted

Study publicly available on registry

December 1, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2021

Completed
Last Updated

January 5, 2022

Status Verified

January 1, 2022

Enrollment Period

7 months

First QC Date

June 12, 2020

Last Update Submit

January 4, 2022

Conditions

COVID-19

Keywords

Inflammatory StormCOVID-19 infectionOmega-3 fatty acidsInflammatory biomarkersOmega-3 index

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (11)

  • Changes in proresolving mediators

    5 days

  • Changes in fatty acids in the erythrocyte fraction

    5 days

  • Changes in cardiac biomarkers

    5 days

  • Changes in biomarkers of organ damage

    5 days

  • Changes in thrombosis parameters

    5 days

  • +6 more secondary outcomes

Study Arms (2)

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

Drug: Omegaven®

Sodium chloride (NaCl)

PLACEBO COMPARATOR

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

Drug: Sodium chloride

Interventions

Omegaven®DRUG

A highly refined fish oil in an emulsion for infusion with purified egg phosphatides and glycerol.

Omega
Sodium chlorideDRUG

intravenously administered 2 mL/kg/day

Sodium chloride (NaCl)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of signed informed consent prior to any study specific procedures.
  • Female and male patients ≥18 years of age.
  • COVID-19 positive or typical CT image of COVID-19 infection.
  • Clinical status requiring hospitalization.

You may not qualify if:

  • According to Omegaven® contraindications (serious bleeding disorders, acute life-threatening condition, including acute shock, acute myocardial infarction, acute stroke, acute emboli, and coma).
  • Known hypersensitivity to Omegaven® or any of the ingredients.
  • Participation in any clinical research study evaluating an investigational medicinal product (IMP) within 3 months prior to screening.
  • Pregnancy and breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Karolinska Universitetssjuhuset

Stockholm, Sweden

Location

Södersjukhuset

Stockholm, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 33505321DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

fish oil triglyceridesSodium Chloride

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Magnus Bäck, Professor

    Karolinska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Cardiology

Study Record Dates

First Submitted

June 12, 2020

First Posted

December 1, 2020

Study Start

June 23, 2020

Primary Completion

January 5, 2021

Study Completion

July 7, 2021

Last Updated

January 5, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported will be shared, after deidentification, with researchers who provide a methodologically sound proposal.

Shared Documents
STUDY PROTOCOL
Time Frame
Beginning 9 months following article publication and finishing 36 months following article publication.
Access Criteria
Study protocol will be published. Investigators interested in data should contact the principal investigator.

Locations

SE(2)