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Trial record 1 of 1 for:    NCT04647604
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Resolving Inflammatory Storm in COVID-19 Patients by Omega-3 Polyunsaturated Fatty Acids -

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ClinicalTrials.gov Identifier: NCT04647604
Recruitment Status : Completed
First Posted : December 1, 2020
Last Update Posted : January 5, 2022
Sponsor:
Information provided by (Responsible Party):
Magnus Bäck, Karolinska University Hospital

Tracking Information
First Submitted Date  ICMJE June 12, 2020
First Posted Date  ICMJE December 1, 2020
Last Update Posted Date January 5, 2022
Actual Study Start Date  ICMJE June 23, 2020
Actual Primary Completion Date January 5, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 27, 2020)
  • Changes in inflammatory biomarkers [ Time Frame: 5 days ]
    white blood cell counts
  • Changes in inflammatory biomarkers [ Time Frame: 5 days ]
    CRP
  • Changes in inflammatory biomarkers [ Time Frame: 5 days ]
    lipidomic profiling
  • Changes in inflammatory biomarkers [ Time Frame: 5 days ]
    cytokines
  • Changes in inflammatory biomarkers [ Time Frame: 5 days ]
    metabolomic profiling
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2020)
  • Changes in proresolving mediators [ Time Frame: 5 days ]
    lipidomics
  • Changes in fatty acids in the erythrocyte fraction [ Time Frame: 5 days ]
    fatty acid profile
  • Changes in cardiac biomarkers [ Time Frame: 5 days ]
    Troponin, NTproBNP
  • Changes in biomarkers of organ damage [ Time Frame: 5 days ]
    LD, creatinine
  • Changes in thrombosis parameters [ Time Frame: 5 days ]
    platelet count, D-dimer,
  • Changes in coagulation parameters [ Time Frame: 5 days ]
    fibrinogen
  • Changes in markers of infection [ Time Frame: 5 days ]
    procalcitonin concentrations
  • Changes in infection load [ Time Frame: 5 days ]
    SARS-CoV2-RNAemia
  • Changes in clinical parameters [ Time Frame: through study completion, on average 10 days ]
    National Early Warning Score (NEWS2)
  • Length of hospital stay [ Time Frame: through study completion, on average 10 days ]
    Days of hospital stay
  • Complications [ Time Frame: through study completion, on average 10 days ]
    ICU need, mortality
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Resolving Inflammatory Storm in COVID-19 Patients by Omega-3 Polyunsaturated Fatty Acids -
Official Title  ICMJE Resolving Inflammatory Storm in COVID-19 Patients by Omega-3 Polyunsaturated Fatty Acids - A Single-blind, Randomized, Placebo-controlled Feasibility Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Drug: Omegaven®
    A highly refined fish oil in an emulsion for infusion with purified egg phosphatides and glycerol.
  • Drug: Sodium chloride
    intravenously administered 2 mL/kg/day
Study Arms  ICMJE
  • 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
    Intervention: Drug: Omegaven®
  • Placebo Comparator: Sodium chloride (NaCl)
    2 mL/kg/day) once daily for 5 days
    Intervention: Drug: Sodium chloride
Publications * Arnardottir H, Pawelzik SC, Öhlund Wistbacka U, Artiach G, Hofmann R, Reinholdsson I, Braunschweig F, Tornvall P, Religa D, Bäck 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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 4, 2022)
23
Original Estimated Enrollment  ICMJE
 (submitted: November 27, 2020)
40
Actual Study Completion Date  ICMJE July 7, 2021
Actual Primary Completion Date January 5, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04647604
Other Study ID Numbers  ICMJE 2020-002293-28
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported will be shared, after deidentification, with researchers who provide a methodologically sound proposal.
Supporting Materials: 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.
Responsible Party Magnus Bäck, Karolinska University Hospital
Study Sponsor  ICMJE Karolinska University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Magnus Bäck, Professor Karolinska University Hospital
PRS Account Karolinska University Hospital
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP