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Clinical Trials/EUCTR2020-002293-28-SE
EUCTR2020-002293-28-SE
Active, not recruiting
Phase 1

Resolving inflammatory storm in COVID-19 patients by Omega-3 polyunsaturated fatty acids.- A single-blind, randomized, placebo-controlled feasibility study

Karolinska University Hospital0 sites40 target enrollmentMay 13, 2020
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ConditionsSARS-COV-2 InfectionMedDRA version: 23.0Level: LLTClassification code 10084272Term: SARS-CoV-2 infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
DrugsOmegaven

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
SARS-COV-2 Infection
Sponsor
Karolinska University Hospital
Enrollment
40
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 13, 2020
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Karolinska University Hospital

Eligibility 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.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 20
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 20

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.

Outcomes

Primary Outcomes

Not specified

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