NCT04460651: PREPARE-IT

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

Completed Phase 3 Last updated 17 September 2021

What this trial tests

Phase 3 trial testing Icosapent ethyl (IPE) in COVID19 in 4,093 participants. Completed in 30 August 2021.

Timeline

14 August 2020

Primary endpoint
30 August 2021

30 August 2021

Quick facts

Lead sponsor	Estudios Clínicos Latino América
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	4,093
Start date	14 August 2020
Primary completion	30 August 2021
Estimated completion	30 August 2021
Sites	1 location across Argentina

Drugs / interventions tested

• Icosapent ethyl (IPE) — full drug profile →
• Placebo

Conditions studied

• COVID19 — all drugs for COVID19 →

Sponsor

Estudios Clínicos Latino América — full company profile →

Who can join

18 and older, any sex, with COVID19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Long COVID: post-acute sequelae of COVID-19 with a cardiovascular focus.
   Raman B, Bluemke DA, Lüscher TF, Neubauer S. · · 2022 · cited 444× · PMID 35176758 · DOI 10.1093/eurheartj/ehac031
2. Cardiac involvement in the long-term implications of COVID-19.
   Satterfield BA, Bhatt DL, Gersh BJ. · · 2022 · cited 101× · PMID 34686843 · DOI 10.1038/s41569-021-00631-3
3. The roles of lipids in SARS-CoV-2 viral replication and the host immune response.
   Theken KN, Tang SY, Sengupta S, FitzGerald GA. · · 2021 · cited 59× · PMID 34599996 · DOI 10.1016/j.jlr.2021.100129
4. Metabolic alterations upon SARS-CoV-2 infection and potential therapeutic targets against coronavirus infection.
   Chen P, Wu M, He Y, Jiang B, et al · · 2023 · cited 50× · PMID 37286535 · DOI 10.1038/s41392-023-01510-8
5. Therapeutics for COVID-19 and post COVID-19 complications: An update.
   Basu D, Chavda VP, Mehta AA. · · 2022 · cited 44× · PMID 35136858 · DOI 10.1016/j.crphar.2022.100086
6. Dietary Fish, Fish Nutrients, and Immune Function: A Review.
   Mendivil CO. · · 2020 · cited 39× · PMID 33553231 · DOI 10.3389/fnut.2020.617652
7. 2-Deoxy-D-Glucose and its Derivatives for the COVID-19 Treatment: An Update.
   Huang Z, Chavda VP, Vora LK, Gajjar N, et al · · 2022 · cited 29× · PMID 35496298 · DOI 10.3389/fphar.2022.899633
8. A randomized trial of icosapent ethyl in ambulatory patients with COVID-19.
   Kosmopoulos A, Bhatt DL, Meglis G, Verma R, et al · · 2021 · cited 19× · PMID 34462732 · DOI 10.1016/j.isci.2021.103040