Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04460651 | PREPARE-IT. Prevention and Treatment of COVID19 With EPA in Subjects at Risk - Intervention Trial | PHASE3 | COMPLETED | 4,093 | — | — | Aug 14, 2020 | Aug 30, 2021 | Sep 17, 2021 | 1 | Argentina |
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).
| Arm | Type | Description |
|---|---|---|
| Active treatment | ACTIVE_COMPARATOR | Participants in this arm will receive study medication icosapent ethyl (IPE) with a specific dose scheme. |
| Placebo | PLACEBO_COMPARATOR | Participants in this arm will receive Placebo with the same dose scheme as the active comparator: |
| Name | Type | Description |
|---|---|---|
| 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) |
| 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) |
(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 breastf...