PREPARE-IT. Prevention and Treatment of COVID19 With EPA in Subjects at Risk - Intervention Trial (PREPARE-IT)
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ClinicalTrials.gov Identifier: NCT04460651 |
Recruitment Status :
Completed
First Posted : July 7, 2020
Last Update Posted : September 17, 2021
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Tracking Information | |||||||
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First Submitted Date ICMJE | July 2, 2020 | ||||||
First Posted Date ICMJE | July 7, 2020 | ||||||
Last Update Posted Date | September 17, 2021 | ||||||
Actual Study Start Date ICMJE | August 14, 2020 | ||||||
Actual Primary Completion Date | August 30, 2021 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | PREPARE-IT. Prevention and Treatment of COVID19 With EPA in Subjects at Risk - Intervention Trial | ||||||
Official Title ICMJE | PREPARE-IT. Prevention and Treatment of COVID19 With EPA in Subjects at Risk - Intervention Trial | ||||||
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). | ||||||
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 to vaccines is limited globally, and emergence of COVID-19 viral mutations and vaccine breakthrough cases underscore the need for complementary effective therapies. To date, there are limited systemic options available for effective treatment from viral-inhibitors, polyclonal antibodies (immunomodulatory drugs) to mitigate the inflammatory cascade and subsequent cytokine storm, and low-dose steroids such as dexamethasone in high-risk patients, which was associated with a reduction in mortality. Icosapent ethyl (IPE) is a safe, well-tolerated oral therapy proven to be effective in improving outcomes in patients with established cardiovascular disease or diabetes with one or more additional risk factors. In the context of COVID-19, a recent pilot study on 50 patients on a loading dose of 8g/day for three days, followed by 4g/daily showed a significant improvement in validated patient-reported FLU-PRO score symptoms. A corresponding reduction in a key biomarker of inflammation (hs-CRP) was also detected within the IPE arm at 14 days. While this pilot study provides the first evidence of an early anti-inflammatory effect of IPE, to confirm these findings, we designed a randomized, placebo-controlled study program investigating IPE with a similar loading dose intended to reduce infection rates and subsequent morbidity and mortality among subjects at high risk of infection from SARS-CoV-2 (prevention arm), and to reduce the hospitalization rate and complications in patients with a positive diagnosis of COVID-19 (treatment arm). |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Simple, pragmatic, double-blind, placebo-controlled trial Masking: Triple (Participant, Care Provider, Investigator)Primary Purpose: Treatment |
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Condition ICMJE | COVID19 | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
4093 | ||||||
Original Estimated Enrollment ICMJE |
1500 | ||||||
Actual Study Completion Date ICMJE | August 30, 2021 | ||||||
Actual Primary Completion Date | August 30, 2021 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | (A) Prevention arm: Inclusion Criteria:
Exclusion Criteria:
(B) Treatment arm: Inclusion Criteria:
Exclusion Criteria:
Subjects who fill out the pre-selection form will be evaluated and approved for admission to the clinical trial after confirming their entry criteria |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Argentina | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04460651 | ||||||
Other Study ID Numbers ICMJE | PREPARE-IT. Version 4.0 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Estudios Clínicos Latino América | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Estudios Clínicos Latino América | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Amarin Pharma Inc. | ||||||
Investigators ICMJE |
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PRS Account | Estudios Clínicos Latino América | ||||||
Verification Date | August 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |