NCT07711444

Brief Summary

Researchers 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. Researchers 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 14, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
Last Updated

July 21, 2026

Status Verified

July 1, 2026

Enrollment Period

1.5 years

First QC Date

July 14, 2026

Last Update Submit

July 20, 2026

Conditions

Keywords

SPMEPADepression

Outcome Measures

Primary Outcomes (1)

  • Hamilton Depression Rating Scale (HAMD)

    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 Outcomes (1)

  • Erythrocyte Omega-3 Polyunsaturated Fatty Acids

    Week 0 and Week 12

Study Arms (3)

Eicosapentaenoic acid (EPA)

EXPERIMENTAL

Eicosapentaenoic acid (EPA) at a total daily dose of 3 g, administered as six capsules

Dietary Supplement: Eicosapentaenoic acid (omega-3 fatty acid)

Specialized pro-resolving mediators (SPMs)

EXPERIMENTAL

SPM at a total daily dose of 1.67 g, administered as six capsules

Dietary Supplement: Specialized Pro-Resolving Lipid Mediator

Placebo

PLACEBO COMPARATOR

soybean oil

Dietary Supplement: Placebo

Interventions

A total daily dose of 3 g, administered as six capsules

Also known as: EPA
Eicosapentaenoic acid (EPA)
PlaceboDIETARY_SUPPLEMENT

Six capsules containing soybean oil daily

Placebo

A total daily dose of 1.67 g, administered as six capsules

Also known as: SPM
Specialized pro-resolving mediators (SPMs)

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed SARS-CoV-2 infection by PCR, documented positive test, or clinician diagnosis
  • 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
  • Hamilton Depression Rating Scale (HAMD-21) score ≥18 at baseline
  • Stable antidepressant treatment for ≥4 weeks or no current antidepressant use; and
  • Ability to provide written informed consent

You may not qualify if:

  • 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
  • Significant neurological or medical comorbidities (eg, epilepsy, traumatic brain injury, autoimmune disease, cancer), acute infections, or clinically significant laboratory abnormalities
  • Regular use of SPM or EPA supplementation \>0·5 g/day
  • Known allergy or intolerance to omega-3 fatty acids or SPMs; and
  • Requirement for inpatient psychiatric care due to acute suicide risk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mind-Body Interface Research Center (MBI Lab & Care)

Taichung, Taichung, 404, Taiwan

Location

MeSH Terms

Conditions

COVID-19Depression

Interventions

Eicosapentaenoic AcidFatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsEicosanoidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The interventional model, including the supplementation of EPA and SPM
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 14, 2026

First Posted

July 17, 2026

Study Start

June 1, 2024

Primary Completion

December 1, 2025

Study Completion

June 1, 2026

Last Updated

July 21, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations