Resolving Inflammatory Storm in COVID-19 Patients by Omega-3 Polyunsaturated Fatty Acids -

COVID-19 Clinical Trial

Official title:

Resolving Inflammatory Storm in COVID-19 Patients by Omega-3 Polyunsaturated Fatty Acids - A Single-blind, Randomized, Placebo-controlled Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04647604
• Other study ID #: 2020-002293-28
• Status: Completed
• Phase: Phase 2
• Start date: June 23, 2020
• Est. completion date: July 7, 2021

Study information

• Verified date: January 2022
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: July 7, 2021
• Est. primary completion date: January 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Omegaven®
A highly refined fish oil in an emulsion for infusion with purified egg phosphatides and glycerol.
• Sodium chloride
intravenously administered 2 mL/kg/day

Locations

Country	Name	City	State
Sweden	Karolinska Universitetssjuhuset	Stockholm
Sweden	Södersjukhuset	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in inflammatory biomarkers	white blood cell counts	5 days
Primary	Changes in inflammatory biomarkers	CRP	5 days
Primary	Changes in inflammatory biomarkers	lipidomic profiling	5 days
Primary	Changes in inflammatory biomarkers	cytokines	5 days
Primary	Changes in inflammatory biomarkers	metabolomic profiling	5 days
Secondary	Changes in proresolving mediators	lipidomics	5 days
Secondary	Changes in fatty acids in the erythrocyte fraction	fatty acid profile	5 days
Secondary	Changes in cardiac biomarkers	Troponin, NTproBNP	5 days
Secondary	Changes in biomarkers of organ damage	LD, creatinine	5 days
Secondary	Changes in thrombosis parameters	platelet count, D-dimer,	5 days
Secondary	Changes in coagulation parameters	fibrinogen	5 days
Secondary	Changes in markers of infection	procalcitonin concentrations	5 days
Secondary	Changes in infection load	SARS-CoV2-RNAemia	5 days
Secondary	Changes in clinical parameters	National Early Warning Score (NEWS2)	through study completion, on average 10 days
Secondary	Length of hospital stay	Days of hospital stay	through study completion, on average 10 days
Secondary	Complications	ICU need, mortality	through study completion, on average 10 days