Status:
COMPLETED
PREPARE-IT. Prevention and Treatment of COVID19 With EPA in Subjects at Risk - Intervention Trial
Lead Sponsor:
Estudios Clínicos Latino América
Collaborating Sponsors:
Amarin Pharma Inc.
Conditions:
COVID19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Detailed Description
Few vaccines have received emergency authorization providing relative immunity, reducing both transmission and infection rates and subsequent associated morbidity and mortality. However, broad access ...
Eligibility Criteria
Inclusion
- (A) Prevention arm:
- 18 years of age or older and
- any subject that is circulating and exposed to the public
Exclusion
- 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:
- Inclusion Criteria:
- 40 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).
Key Trial Info
Start Date :
August 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2021
Estimated Enrollment :
4093 Patients enrolled
Trial Details
Trial ID
NCT04460651
Start Date
August 14 2020
End Date
August 30 2021
Last Update
September 17 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Instituto de Investigaciones Clínicas - Rosario
Rosario, Santa Fe Province, Argentina, 2000