The Efficacy of Long-Chain Fatty Acids, Eicosapentaenoic Acid (EPA) and Specialized Pro-Resolving Mediators (SPMs), in Treating Long COVID Neuropsychiatric Symptoms: A Double-Blind Placebo-Controlled Clinical Trial and Analysis of Inflammatory Markers and Microbiome

July 14, 2026 updated by: Kuan-Pin, National Science and Technology Council, Taiwan

Eicosapentaenoic Acid and Specialized Pro-Resolving Mediator for Depressive Symptoms in Long COVID: A Randomized Controlled Trial

We conducted a 12-week, double-blind, randomized, placebo-controlled trial to assess the effectiveness of EPA or SPM treatments versus a placebo in managing Long COVID symptoms in adult patients. We planned to enroll 240 eligible participants from various general and psychiatric hospitals in Taiwan. The focus was on evaluating the therapeutic impact and potential side effects of administering 3 g/day of EPA or 1.67 mg/day of SPMs on symptoms of depression in these patients. This consolidated approach aims to provide comprehensive insights into the efficacy of EPA and SPM treatments in Long COVID cases, addressing crucial mental health aspects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Taichung
      • Taichung, Taichung, Taiwan, 404
        • Mind-Body Interface Research Center (MBI Lab & Care)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • (1) confirmed SARS-CoV-2 infection by PCR, documented positive test, or clinician diagnosis; (2) meeting CDC criteria for Post-COVID Conditions (Long COVID) as the presence of new, returning, or ongoing symptoms ≥4 weeks after confirmed SARS-CoV-2 infection; (3) Hamilton Depression Rating Scale (HAMD-21) score ≥18 at baseline; (4) stable antidepressant treatment for ≥4 weeks or no current antidepressant use; and (5) ability to provide written informed consent

Exclusion Criteria:

  • (1) current or past six-month diagnosis of psychotic disorder, bipolar disorder, substance use disorder, or other major psychiatric conditions based on ICD-10 or DSM-5 criteria; (2) significant neurological or medical comorbidities (eg, epilepsy, traumatic brain injury, autoimmune disease, cancer), acute infections, or clinically significant laboratory abnormalities; (3) regular use of SPM or EPA supplementation >0·5 g/day; (4) known allergy or intolerance to omega-3 fatty acids or SPMs; and (5) requirement for inpatient psychiatric care due to acute suicide risk

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Eicosapentaenoic acid (EPA)
Eicosapentaenoic acid (EPA) at a total daily dose of 3 g, administered as six capsules
Dietary supplement: Eicosapentaenoic acid (omega-3 fatty acid)
A total daily dose of 3 g, administered as six capsules
Other Names:
  • EPA
Experimental: Specialized pro-resolving mediators (SPMs)
SPM at a total daily dose of 1.67 g, administered as six capsules
Dietary supplement: Specialized Pro-Resolving Lipid Mediator
A total daily dose of 1.67 g, administered as six capsules
Other Names:
  • SPM
Placebo Comparator: Placebo
soybean oil
Dietary supplement: Placebo
Six capsules containing soybean oil daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hamilton Depression Rating Scale (HAMD)
Time Frame: (week 0) and at weeks 1, 2, 4, 8, and 12
Adult depressive symptoms were assessed using the 21-item HAMD at baseline (week 0) and at weeks 1, 2, 4, 8, and 12.
(week 0) and at weeks 1, 2, 4, 8, and 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Erythrocyte Omega-3 Polyunsaturated Fatty Acids
Time Frame: Week 0 and Week 12
Peripheral blood samples were collected at baseline and at the end of the 12-week intervention period using EDTA-containing tubes for erythrocyte fatty acid analysis
Week 0 and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Science and Technology Council, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Actual)

December 1, 2025

Study Completion (Actual)

June 1, 2026

Study Registration Dates

First Submitted

July 14, 2026

First Submitted That Met QC Criteria

July 14, 2026

First Posted (Actual)

July 17, 2026

Study Record Updates

Last Update Posted (Actual)

July 17, 2026

Last Update Submitted That Met QC Criteria

July 14, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH113-REC2-158

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID - 19

Clinical Trials on Eicosapentaenoic acid (omega-3 fatty acid)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe