There is one clinical trial.
This is an open-label, randomized, controlled study in hospitalized subjects with confirmed SARS-CoV-2.
Description: Time to treatment failure during the 28-day treatment period. Treatment failure is defined as additional or alternative treatment required, or intubation and invasive ventilation, or transfer to intensive care unit, or death.
Measure: Evaluation of EPA-FFA efficacy compared to standard of care Time: 28 daysDescription: Time to (in days) and number of days with oxygen saturation >95% without oxygen inhalation during the 28-day treatment period
Measure: Increase in oxygen saturation Time: 28 daysDescription: Time to (in days) and number of days with PaO2/FiO2 >300mmHg without oxygen inhalation during the 28-day treatment period
Measure: PaO2/FiO2 >300mmHg increase Time: 28 daysDescription: Change in IL-6 level during the 28-day treatment period
Measure: Reduction of IL-6 Time: 28 daysDescription: To determine whether EPA-FFA gastro-resistant capsules decreases mortality rate during the study.
Measure: Mortality rate reduction Time: throughout the study, about 3 monthsDescription: To determine whether EPA-FFA gastro-resistant capsules decreases ICU days during the study.
Measure: Reduction in ICU stays Time: throughout the study, about 3 monthsDescription: To determine whether EPA-FFA gastro-resistant capsules decreases hospitalisation days during the study
Measure: Reducing hospitalisation days Time: throughout the study, about 3 monthsDescription: To determine whether EPA-FFA gastro-resistant capsules decreases the need for invasive mechanical ventilation during the study
Measure: reduction in need for mechanical ventilation Time: throughout the study, about 3 monthsDescription: Time to (in days) and number of days with fever normalization < 36.6°C armpit, < 37.2°C oral, < 37.8°C rectal, during the 28-day treatment period
Measure: Fever reduction Time: 28 daysDescription: To evaluate the safety of EPA-FFA gastro-resistant capsules in the treatment of COVID-19 (SARS-CoV-2) by assessing subjects clinical lab parameters and vital signs, and the number and proportion of subjects with AEs.
Measure: Safety - Vitals, AEs and Clinical lab parameters Time: throughout the study, about 3 months