Trial NCT04412018
Publication Kosmopoulos A, iScience, 2021 (published paper)
Dates: 2020-06-04 to 2020-10-30
Funding: Private (Amarin Pharma Inc. and HLS Therapeutics Inc)
Conflict of interest: Yes
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Single center / Canada Follow-up duration (days): 14 | |
| Inclusion criteria | adults 18-75; positive local SARS0CoV-2 PCR test result within the preceding 72 hours of enrollment and at least one of the following symptoms: fever, cough, sore throat, shortness of breath or myalgia |
| Exclusion criteria | 1) Participating in another interventional trial; 2) hospitalized; 3) icurrent medical condition for which life expectancy was less than 3 months; 4) individuals with a history of acute end-organ injury (e.g., myocardial infarction, stroke, hospitalization for acute lung, liver, or kidney disease) within the last month; 5) active severe liver disease; 6) history of acute or chronic pancreatitis; 7) women who were pregnant, may be pregnant, were planning on becoming pregnant, or were lactating; 7) women of child-bearing potential who were not using at least one form of highly effective (hormonal contraceptives [e.g., combined oral contraceptives, patch, vaginal ring, injectables, and implants]; intrauterine device or intrauterine system; tubal ligation or whose partner had a vasectomy) and one effective (barrier methods such male condom, female condom, cervical cap, diaphragm, or contraceptive sponge) method of contraception; 8) history of hemodynamic instability within the past 72 hours including a systolic blood pressure of <95 mmHg and/or a diastolic blood pressure of <50 mmHg; 9) known hypersensitivity to fish and/or shellfish, or ingredients of IPE; 10) any other condition which, in the opinion of the investigator, would place the participant at increased risk, preclude obtaining voluntary consent or confound the objectives of study; 11) unable to swallow IPE capsules whole. |
| Interventions | |
| Treatment
Icosapent ethyl Initial dose: 4 g orally twice a day for 3 days - Maintenance dose: 2 g orally twice a day for 11 days. |
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| Control
Standard care ( / ) Definition of Standard care: * | |
| Participants | |
| Randomized 100 participants (n1=50 / n2= 50) | |
| Characteristics of participants N=100 Mean age : NR 45 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=0 | |
| Primary outcome | |
| In the register Change in hs-CRP levels from the randomization visit (Day 1) to the Day 14 visit [ Time Frame: 14 days ] | |
| In the report Biomarker: unadjusted change in high-sensitivity C-reactive protein (hs-CRP) levels from baseline (day 1) to follow-up (day 14 + 3). Clinical: change in symptomatology as assessed by the InFLUenza Patient-Reported Outcome (FLU-PRO) score. | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated
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| Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
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| General comment |