search
Back to results

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

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Omegaven®
Sodium chloride
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Inflammatory Storm, COVID-19 infection, Omega-3 fatty acids, Inflammatory biomarkers, Omega-3 index

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Karolinska Universitetssjuhuset
  • Södersjukhuset

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Omega

Sodium chloride (NaCl)

Arm 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

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

Outcomes

Primary Outcome Measures

Changes in inflammatory biomarkers
white blood cell counts
Changes in inflammatory biomarkers
CRP
Changes in inflammatory biomarkers
lipidomic profiling
Changes in inflammatory biomarkers
cytokines
Changes in inflammatory biomarkers
metabolomic profiling

Secondary Outcome Measures

Changes in proresolving mediators
lipidomics
Changes in fatty acids in the erythrocyte fraction
fatty acid profile
Changes in cardiac biomarkers
Troponin, NTproBNP
Changes in biomarkers of organ damage
LD, creatinine
Changes in thrombosis parameters
platelet count, D-dimer,
Changes in coagulation parameters
fibrinogen
Changes in markers of infection
procalcitonin concentrations
Changes in infection load
SARS-CoV2-RNAemia
Changes in clinical parameters
National Early Warning Score (NEWS2)
Length of hospital stay
Days of hospital stay
Complications
ICU need, mortality

Full Information

First Posted
June 12, 2020
Last Updated
January 4, 2022
Sponsor
Karolinska University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04647604
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
June 23, 2020 (Actual)
Primary Completion Date
January 5, 2021 (Actual)
Study Completion Date
July 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Inflammatory Storm, COVID-19 infection, Omega-3 fatty acids, Inflammatory biomarkers, Omega-3 index

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Omega
Arm Type
Active Comparator
Arm 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
Arm Title
Sodium chloride (NaCl)
Arm Type
Placebo Comparator
Arm Description
2 mL/kg/day) once daily for 5 days
Intervention Type
Drug
Intervention Name(s)
Omegaven®
Intervention Description
A highly refined fish oil in an emulsion for infusion with purified egg phosphatides and glycerol.
Intervention Type
Drug
Intervention Name(s)
Sodium chloride
Intervention Description
intravenously administered 2 mL/kg/day
Primary Outcome Measure Information:
Title
Changes in inflammatory biomarkers
Description
white blood cell counts
Time Frame
5 days
Title
Changes in inflammatory biomarkers
Description
CRP
Time Frame
5 days
Title
Changes in inflammatory biomarkers
Description
lipidomic profiling
Time Frame
5 days
Title
Changes in inflammatory biomarkers
Description
cytokines
Time Frame
5 days
Title
Changes in inflammatory biomarkers
Description
metabolomic profiling
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Changes in proresolving mediators
Description
lipidomics
Time Frame
5 days
Title
Changes in fatty acids in the erythrocyte fraction
Description
fatty acid profile
Time Frame
5 days
Title
Changes in cardiac biomarkers
Description
Troponin, NTproBNP
Time Frame
5 days
Title
Changes in biomarkers of organ damage
Description
LD, creatinine
Time Frame
5 days
Title
Changes in thrombosis parameters
Description
platelet count, D-dimer,
Time Frame
5 days
Title
Changes in coagulation parameters
Description
fibrinogen
Time Frame
5 days
Title
Changes in markers of infection
Description
procalcitonin concentrations
Time Frame
5 days
Title
Changes in infection load
Description
SARS-CoV2-RNAemia
Time Frame
5 days
Title
Changes in clinical parameters
Description
National Early Warning Score (NEWS2)
Time Frame
through study completion, on average 10 days
Title
Length of hospital stay
Description
Days of hospital stay
Time Frame
through study completion, on average 10 days
Title
Complications
Description
ICU need, mortality
Time Frame
through study completion, on average 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magnus Bäck, Professor
Organizational Affiliation
Karolinska University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Universitetssjuhuset
City
Stockholm
Country
Sweden
Facility Name
Södersjukhuset
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
33505321
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs