PREPARE-IT. Prevention and Treatment of COVID19 With EPA in Subjects at Risk - Intervention Trial

NCT04460651 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: PREPARE-IT. Version 4.0
• Study Type: interventional
• Target: 4,093
• Locations: 1 country
• Sites: 1

Brief Summary

The PREPARE-IT investigator-initiated trial program is a simple, pragmatic, therapeutic strategy evaluating pure icosapent ethyl (IPE) at initially higher doses intended to reduce infection rates and subsequent morbidity and mortality among subjects at high risk of infection due to COVID-19 (prevention arm), and to reduce the hospitalization rate and complications in patients with a positive diagnosis of COVID-19 (treatment arm).

Conditions

COVID19

Keywords

Icosapent ethyl; Vascepa; Eicosapentaenoic acid ethyl ester; Ethyl-EPA; AMR101

Outcome Measures

Primary Outcomes (2)

• (A) Prevention Arm: SARS-CoV-2 positivity assesed up to day 60.

  SARS-CoV-2 positive subjects are defined as subjects with positive tests for SARS-CoV-2 RT-PCR or for SARS-CoV-2 lgG antibodies after developing COVID-19 disease at any stage within the follow-up period (including those subjects with or without symptomatic COVID-19 evaluated before the final visit) or those individuals who test positive for SARS-CoV-2 RT-PCR or for SARS-CoV-2 lgG antibodies at the final visit (day 60).

  60 days

• (B) Treatment Arm: COVID 19 related hospitalization (indication for hospitalization per the blinded investigator or actual hospitalization) or death assessed up to 28 days

  28 days

Secondary Outcomes (10)

• (A) Prevention Arm: High-sensitivity C-reactive Protein (mg/dL) change from baseline to day 60 (key secondary outcome)

  baseline, 60 days

• (A) Prevention Arm: Triglycerides (mg/dL) change from baseline to day 60

  baseline, 60 days

• (A) Prevention Arm: FLU-PRO SCORE change from baseline to day 60 in a subset of subjects

  baseline, 60 days

• (B) Treatment Arm: COVID 19 related hospitalization or death assessed up to 28 days (key secondary outcome)

  28 days

• (B) Treatment Arm: Alive and out of the hospital at 28 days.

  28 days

Study Arms (2)

Active treatment

ACTIVE COMPARATOR

Participants in this arm will receive study medication icosapent ethyl (IPE) with a specific dose scheme.

Drug: Icosapent ethyl (IPE)

Placebo

PLACEBO COMPARATOR

Participants in this arm will receive Placebo with the same dose scheme as the active comparator:

Drug: Placebo

Interventions

Icosapent ethyl (IPE) DRUG

Participants in this arm will receive study medication IPE with the following dosage schedule: 8 g of IPE (4 capsules every 12 hours - morning and evening, with food) for the first three days followed by 4 g of IPE (2 capsules every 12 hours - morning and evening, with food) thereafter (days 4-28 for treatment arm and 4-60 for prevention arm)

Also known as: Vascepa®

Active treatment

Placebo DRUG

Participants in this arm will receive placebo with the following dosage schedule: 8 g of placebo (4 capsules every 12 hours - morning and evening, with food) for the first three days followed by 4 g of placebo (2 capsules every 12 hours - morning and evening, with food) thereafter (days 4-28 for treatment arm and 4-60 for prevention arm)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older and
• any subject that is circulating and exposed to the public

You may not qualify if:

• Previously diagnosed with COVID-19
• Positive pregnancy test at the time of study entry in potentially fertile women
• Pregnant or breastfeeding women
• Subject who has received one or more doses of any vaccine for Sars-Cov-2 or who is scheduled to be vaccinated within the next 60 days
• Unable to provide informed consent
• Clear contraindication to EPA
• Known hypersensitivity to the study drug
• Administration of a drug with anticoagulant effects (antiplatelet agents are allowed)
• Hemorrhagic Diathesis
• (B) Treatment arm:
• years of age or older and
• Covid 19 diagnosis confirmed with SARS Cov-2 test (RT-PCR) and
• No more than 7 days from the onset of symptoms and
• Without clear indication for hospitalization (1-2 in the WHO COVID-19 Descriptive Score).
• Hospitalized patient or with a clear indication of hospitalization for COVID-19

Sponsors & Collaborators

• Estudios Clínicos Latino América: lead
• Amarin Pharma Inc.: collaborator

Study Sites (1)

Instituto de Investigaciones Clínicas - Rosario

Rosario, Santa Fe Province, 2000, Argentina

Location

MeSH Terms

Conditions

COVID-19

Interventions

eicosapentaenoic acid ethyl ester

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Rafael Diaz, MD

  ECLA- Estudios Clínicos Latino América

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Simple, pragmatic, double-blind, placebo-controlled trial

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 7, 2020
• Study Start: August 14, 2020
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: September 17, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)