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

Phase 2

Completed

• Conditions: COVID-19
• Interventions: Drug: Omegaven®; Drug: Sodium chloride

• Registration Number: NCT04647604
• Lead Sponsor: Karolinska University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-12
• Study Start: 2020-06-23
• Study First Submitted QC: 2020-11-27
• Study First Posted: 2020-12-01
• Primary Completion: 2021-01-05
• Study Completion: 2021-07-07
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-04
• Last Update Posted: 2022-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omega	Omegaven®	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
Sodium chloride (NaCl)	Sodium chloride	2 mL/kg/day) once daily for 5 days

Primary Outcome Measures

Name	Time	Method
Changes in inflammatory biomarkers	5 days	metabolomic profiling

Secondary Outcome Measures

Name	Time	Method
Changes in thrombosis parameters	5 days	platelet count, D-dimer,
Changes in coagulation parameters	5 days	fibrinogen
Changes in infection load	5 days	SARS-CoV2-RNAemia
Changes in clinical parameters	through study completion, on average 10 days	National Early Warning Score (NEWS2)
Length of hospital stay	through study completion, on average 10 days	Days of hospital stay
Complications	through study completion, on average 10 days	ICU need, mortality
Changes in fatty acids in the erythrocyte fraction	5 days	fatty acid profile
Changes in cardiac biomarkers	5 days	Troponin, NTproBNP
Changes in biomarkers of organ damage	5 days	LD, creatinine
Changes in proresolving mediators	5 days	lipidomics
Changes in markers of infection	5 days	procalcitonin concentrations

Trial Locations

Locations (2)

Karolinska Universitetssjuhuset; 🇸🇪 Stockholm, Sweden

Södersjukhuset; 🇸🇪 Stockholm, Sweden