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

• Sponsor: Karolinska University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04647604
• Collaborator: (none)
• Enrollment: 23
• Locations: 2
• Arms: 2
• Actual Duration (Months): 12.5
• Patients Per Site: 11.5
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: Omegaven®; Drug: Sodium chloride	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Resolving Inflammatory Storm in COVID-19 Patients by Omega-3 Polyunsaturated Fatty Acids - A Single-blind, Randomized, Placebo-controlled Feasibility Study
• Actual Study Start Date: Jun 23, 2020
• Actual Primary Completion Date: Jan 5, 2021
• Actual Study Completion Date: Jul 7, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Changes in inflammatory biomarkers [5 days]

   white blood cell counts

2. Changes in inflammatory biomarkers [5 days]

   CRP

3. Changes in inflammatory biomarkers [5 days]

   lipidomic profiling

4. Changes in inflammatory biomarkers [5 days]

   cytokines

5. Changes in inflammatory biomarkers [5 days]

   metabolomic profiling

Secondary Outcome Measures

1. Changes in proresolving mediators [5 days]

   lipidomics

2. Changes in fatty acids in the erythrocyte fraction [5 days]

   fatty acid profile

3. Changes in cardiac biomarkers [5 days]

   Troponin, NTproBNP

4. Changes in biomarkers of organ damage [5 days]

   LD, creatinine

5. Changes in thrombosis parameters [5 days]

   platelet count, D-dimer,

6. Changes in coagulation parameters [5 days]

   fibrinogen

7. Changes in markers of infection [5 days]

   procalcitonin concentrations

8. Changes in infection load [5 days]

   SARS-CoV2-RNAemia

9. Changes in clinical parameters [through study completion, on average 10 days]

   National Early Warning Score (NEWS2)

10. Length of hospital stay [through study completion, on average 10 days]

    Days of hospital stay

11. Complications [through study completion, on average 10 days]

    ICU need, mortality

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karolinska Universitetssjuhuset	Stockholm		Sweden
2	Södersjukhuset	Stockholm		Sweden

Sponsors and Collaborators

• Karolinska University Hospital

Investigators

• Principal Investigator: Magnus Bäck, Professor, Karolinska University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Magnus Bäck, Professor of Cardiology, Karolinska University Hospital
• ClinicalTrials.gov Identifier: NCT04647604
• Other Study ID Numbers: 2020-002293-28
• First Posted: Dec 1, 2020
• Last Update Posted: Jan 5, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Magnus Bäck, Professor of Cardiology, Karolinska University Hospital: Inflammatory Storm; COVID-19 infection; Omega-3 fatty acids; Inflammatory biomarkers; Omega-3 index
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Jan 5, 2022