COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-002293-28/SE

Karolinska University Hospital - Co-ordinating investigator

magnus.back@ki.se

2020-05-13

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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.

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.

2

Karolinska University Hospital

18

100

Sweden

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

40

Changes in a panel of inflammatory biomarkers measured in blood samples, urine samples and released from ex vivo stimulated leukocytes after 5 days of treatment.

Declared number of arm (3.0) differs from found arms (2.0)

Phase 2

[{"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"}]