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An Investigation on the Effects of Icosapent Ethyl (VascepaTM) on Inflammatory Biomarkers in Individuals With COVID-19

NCT04412018 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-12-22

No results posted yet for this study

Summary

This is a 14-day long prospective, multi-site, two-armed, randomized, open-label study that will enroll approximately 100 adult outpatients in Canada who have received a positive SARS-CoV-2 test result within the preceding 72 hours. Participants will be randomized (1:1) to receive either icosapent ethyl (4 g BID for 3 days, then 2 g BID for the subsequent 11 days) or usual care. Blood samples will be collected to determine if icosapent ethyl use lowers circulating pro-inflammatory biomarkers.

Conditions

Interventions

DRUG

Icosapent ethyl

Icosapent ethyl (4 g BID for 3 days, then 2 g BID for the subsequent 11 days)

Sponsors & Collaborators

  • Amarin Corporation

    collaborator UNKNOWN

  • HLS Therapeutics, Inc

    collaborator UNKNOWN

  • Canadian Medical and Surgical Knowledge Translation Research Group

    lead OTHER

Principal Investigators

  • Subodh Verma, MD, PhD · Canadian Medical and Surgical Knowledge Translation Research Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-04
Primary Completion
2020-11-06
Completion
2020-12-12
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04412018 on ClinicalTrials.gov