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Trial - NCT04647604


Column Value
Trial registration number NCT04647604
Full text link
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04647604

First author
Last imported at : Jan. 7, 2022, 8 a.m.
Source : ClinicalTrials.gov

Magnus Bäck, Professor

Contact
Last imported at : Jan. 7, 2022, 8 a.m.
Source : ClinicalTrials.gov

magnus.back@ki.se

Registration date
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

2020-12-01

Recruitment status
Last imported at : Jan. 7, 2022, 8 a.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

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
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

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.

Number of arms
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Karolinska University Hospital

Inclusion age min
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Sweden

Type of patients
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Moderate/severe/critical disease at enrollment

Severity scale
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

5: Moderate/severe/critical disease at enrollment

Total sample size
Last imported at : Jan. 7, 2022, 8 a.m.
Source : ClinicalTrials.gov

23

primary outcome
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Changes in inflammatory biomarkers;Changes in inflammatory biomarkers;Changes in inflammatory biomarkers;Changes in inflammatory biomarkers;Changes in inflammatory biomarkers

Notes
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : Dec. 3, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 580, "treatment_name": "Highly refined fish oil", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]