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

Study Overview
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Brief Summary
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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.

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

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Omegaven®
* Drug: Sodium chloride


Participation Criteria
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Eligibility Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Omega<br>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 | Drug: Omegaven®<br>* A highly refined fish oil in an emulsion for infusion with purified egg phosphatides and glycerol.<br>|
| Placebo Comparator: Sodium chloride (NaCl)<br>2 mL/kg/day) once daily for 5 days | Drug: Sodium chloride<br>* intravenously administered 2 mL/kg/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in inflammatory biomarkers | white blood cell counts | 5 days | 
| Changes in inflammatory biomarkers | CRP | 5 days | 
| Changes in inflammatory biomarkers | lipidomic profiling | 5 days | 
| Changes in inflammatory biomarkers | cytokines | 5 days | 
| Changes in inflammatory biomarkers | metabolomic profiling | 5 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammatory Storm, COVID-19 infection, Omega-3 fatty acids, Inflammatory biomarkers, Omega-3 index