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

• Status: Completed
• Trial end date: 2021-08-30
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Estudios Clínicos Latino América
• Collaborator: Amarin Pharma Inc.
• Treatments: Eicosapentaenoic acid ethyl ester

Criteria

(A) Prevention arm:

Inclusion Criteria:

1. 18 years of age or older and

2. any subject that is circulating and exposed to the public

Exclusion Criteria:

1. Previously diagnosed with COVID-19

2. Positive pregnancy test at the time of study entry in potentially fertile women

3. Pregnant or breastfeeding women

4. 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

5. Unable to provide informed consent

6. Clear contraindication to EPA

7. Known hypersensitivity to the study drug

8. Administration of a drug with anticoagulant effects (antiplatelet agents are allowed)

9. Hemorrhagic Diathesis

(B) Treatment arm:

Inclusion Criteria:

1. 40 years of age or older and

2. Covid 19 diagnosis confirmed with SARS Cov-2 test (RT-PCR) and

3. No more than 7 days from the onset of symptoms and

4. Without clear indication for hospitalization (1-2 in the WHO COVID-19 Descriptive Score).

Exclusion Criteria:

1. Hospitalized patient or with a clear indication of hospitalization for COVID-19

2. Pregnant or breastfeeding women

3. Lack of access to adequate means of communication via the web

4. Unable to provide informed consent

5. Clear contraindication to EPA

6. Known hypersensitivity to the study drug

7. Administration of a drug with anticoagulant effects (antiplatelet agents are allowed)

8. Hemorrhagic Diathesis

Subjects who fill out the pre-selection form will be evaluated and approved for admission to the clinical trial after confirming their entry criteria