|
NCT04505098
|
A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults |
Active, not recruiting |
Phase 4 |
Aug/07/2020 |
Feb/28/2023 |
- Alternative id - 1597940
- Interventions - Drug: Icosapent ethyl
- Study type - Interventional
- Study results - No Results Available
- Locations - Kaiser Permanente Northern California, Oakland, California, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Prevention
- Enrollment - 39600
- Age - 50 Years and older (Adult, Older Adult)
- Outcome measures - Rate of confirmed viral URIs|Percentage of patients with moderate or severe confirmed viral URIs|Worst clinical status due to a confirmed viral URI
|
|
NCT04460651
|
PREPARE-IT. Prevention and Treatment of COVID19 With EPA in Subjects at Risk - Intervention Trial |
Completed |
Phase 3 |
Aug/14/2020 |
Aug/30/2021 |
- Alternative id - PREPARE-IT. Version 4.0
- Interventions - Drug: Icosapent ethyl (IPE)|Drug: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Instituto de Investigaciones Clínicas - Rosario, Rosario, Santa Fe, Argentina
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
- Enrollment - 4093
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - (A) Prevention Arm: SARS-CoV-2 positivity assesed up to day 60.|(B) Treatment Arm: COVID 19 related hospitalization (indication for hospitalization per the blinded investigator or actual hospitalization) or death assessed up to 28 days|(A) Prevention Arm: High-sensitivity C-reactive Protein (mg/dL) change from baseline to day 60 (key secondary outcome)|(A) Prevention Arm: Triglycerides (mg/dL) change from baseline to day 60|(A) Prevention Arm: FLU-PRO SCORE change from baseline to day 60 in a subset of subjects|(B) Treatment Arm: COVID 19 related hospitalization or death assessed up to 28 days (key secondary outcome)|(B) Treatment Arm: Alive and out of the hospital at 28 days.|(B) Treatment Arm: In hospital length of stay assessed up to 28 days|(B) Treatment Arm: New requirement of mechanical ventilation assed up to 28 days.|(B) Treatment Arm: Total events: non-fatal myocardial infarction or non-fatal stroke or death (initial and subsequent), until day 28.|(B) Treatment Arm: Total mortality assessed up to 28 days|(B) Treatment Arm: FLU-PRO SCORE change from baseline at 28 days
|
|
NCT04828538
|
Vitamin D, Omega-3, and Combination Vitamins B, C and Zinc Supplementation for the Treatment and Prevention of COVID-19 |
Active, not recruiting |
Not Applicable |
Jan/01/2021 |
Nov/30/2021 |
- Alternative id - MCI102020
- Interventions - Dietary Supplement: Vitamin D|Dietary Supplement: Omega DHA / EPA|Dietary Supplement: Vitamin C, Vitamin B complex and Zinc Acetate|Other: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Hospital de Soledad, San Luis Potosí, SLP, Mexico
- Study designs - Allocation: Randomized|Intervention Model: Factorial Assignment|Masking: Double (Participant, Care Provider)|Primary Purpose: Other
- Enrollment - 1800
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Covid infection rate (PREVENT Trial only)|Incidence of severe outcome (TREAT Trial only)|Incidence of hospitalization and death (PREVENT Trial only)|Length of hospitalization and death after discharge (TREAT Trial only)
|
|
NCT04412018
|
An Investigation on the Effects of Icosapent Ethyl (VascepaTM) on Inflammatory Biomarkers in Individuals With COVID-19 |
Completed |
Phase 2 |
Jun/04/2020 |
Dec/12/2020 |
- Alternative id - Pro00043601
- Interventions - Drug: Icosapent ethyl
- Study type - Interventional
- Study results - No Results Available
- Locations - North York Diagnostic and Cardiology Clinic, Toronto, Ontario, Canada
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 100
- Age - 18 Years to 75 Years (Adult, Older Adult)
- Outcome measures - Change in hs-CRP levels from the randomization visit (Day 1) to the Day 14 visit|Change in D-dimer levels from the randomization visit (Day 1) to the Day 14 visit|Change in erythrocyte sedimentation rate from the randomization visit (Day 1) to the Day 14 visit|Change in complete blood count from the randomization visit (Day 1) to the Day 14 visit|Change in differential count from the randomization visit (Day 1) to the Day 14 visit|Change in serum albumin levels from the randomization visit (Day 1) to the Day 14 visit|Change in neutrophil-to-lymphocyte ratio (NLR) from the randomization visit (Day 1) to the Day 14 visit|Change in systemic immune-inflammation index from the randomization visit (Day 1) to the Day 14 visit
|
|
NCT04335032
|
EPA-FFA to Treat Hospitalised Patients With COVID-19 (SARS-CoV-2) |
Recruiting |
Phase 3 |
Jan/08/2021 |
Dec/01/2021 |
- Alternative id - EPA-COV-001
- Interventions - Drug: Eicosapentaenoic acid gastro-resistant capsules|Drug: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Hospital Universitario Vall d'Hebron, Barcelona, Spain|Hull, Cottingham, United Kingdom|UHCW, Coventry, United Kingdom|NPH, Harrow, United Kingdom|Rotherham NHS Foundation Trust, Rotherham, United Kingdom
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
- Enrollment - 284
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Evaluation of EPA-FFA efficacy compared to placebo|Time to and amount of clinical improvement|Change in recovery and survival rate|Reduction of CRP and IL-6|Increase in IFN-γ|Reduction in proinflammatory chemokines and cytokines.
|
