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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Omegaven® Drug: Sodium chloride Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Resolving Inflammatory Storm in COVID-19 Patients by Omega-3 Polyunsaturated Fatty Acids - A Single-blind, Randomized, Placebo-controlled Feasibility Study
Actual Study Start Date : June 23, 2020
Actual Primary Completion Date : January 5, 2021
Actual Study Completion Date : July 7, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Changes in inflammatory biomarkers [ Time Frame: 5 days ]
    white blood cell counts

  2. Changes in inflammatory biomarkers [ Time Frame: 5 days ]
    CRP

  3. Changes in inflammatory biomarkers [ Time Frame: 5 days ]
    lipidomic profiling

  4. Changes in inflammatory biomarkers [ Time Frame: 5 days ]
    cytokines

  5. Changes in inflammatory biomarkers [ Time Frame: 5 days ]
    metabolomic profiling


Secondary Outcome Measures :
  1. Changes in proresolving mediators [ Time Frame: 5 days ]
    lipidomics

  2. Changes in fatty acids in the erythrocyte fraction [ Time Frame: 5 days ]
    fatty acid profile

  3. Changes in cardiac biomarkers [ Time Frame: 5 days ]
    Troponin, NTproBNP

  4. Changes in biomarkers of organ damage [ Time Frame: 5 days ]
    LD, creatinine

  5. Changes in thrombosis parameters [ Time Frame: 5 days ]
    platelet count, D-dimer,

  6. Changes in coagulation parameters [ Time Frame: 5 days ]
    fibrinogen

  7. Changes in markers of infection [ Time Frame: 5 days ]
    procalcitonin concentrations

  8. Changes in infection load [ Time Frame: 5 days ]
    SARS-CoV2-RNAemia

  9. Changes in clinical parameters [ Time Frame: through study completion, on average 10 days ]
    National Early Warning Score (NEWS2)

  10. Length of hospital stay [ Time Frame: through study completion, on average 10 days ]
    Days of hospital stay

  11. Complications [ Time Frame: through study completion, on average 10 days ]
    ICU need, mortality


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04647604


Locations
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Sweden
Karolinska Universitetssjuhuset
Stockholm, Sweden
Södersjukhuset
Stockholm, Sweden
Sponsors and Collaborators
Karolinska University Hospital
Investigators
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Principal Investigator: Magnus Bäck, Professor Karolinska University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Magnus Bäck, Professor of Cardiology, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT04647604    
Other Study ID Numbers: 2020-002293-28
First Posted: December 1, 2020    Key Record Dates
Last Update Posted: January 5, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Magnus Bäck, Karolinska University Hospital:
Inflammatory Storm
COVID-19 infection
Omega-3 fatty acids
Inflammatory biomarkers
Omega-3 index
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases