EPA-FFA to Treat Hospitalised Patients With COVID-19 (SARS-CoV-2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04335032|
Recruitment Status : Recruiting
First Posted : April 6, 2020
Last Update Posted : December 3, 2021
|Condition or disease||Intervention/treatment||Phase|
|SARS-CoV-2||Drug: Eicosapentaenoic acid gastro-resistant capsules Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||284 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomised, Double-blind, Placebo Controlled Study of Eicosapentaenoic Acid (EPA-FFA) Gastro-resistant Capsules to Treat Hospitalised Subjects With Confirmed SARS-CoV-2|
|Actual Study Start Date :||January 8, 2021|
|Estimated Primary Completion Date :||November 30, 2021|
|Estimated Study Completion Date :||December 1, 2021|
Experimental: Eicosapentaenoic acid gastro-resistant capsules
Eicosapentaenoic acid free fatty acid (EPA-FFA) 500mg gastro-resistant capsules 2g daily (two capsules twice daily).
One capsule of EPA-FFA gastro-resistant capsules contains 500mg EPA-FFA in a capsule containing gelatin, glycerol, sorbitol, titanium dioxide, FD&C blue No. 1, hypromellose phthalate, dibutyl sebacate.
Drug: Eicosapentaenoic acid gastro-resistant capsules
same as in arm/group description
Other Name: Alfa
Placebo Comparator: Placebo
Placebo capsules that cannot be visually differentiated from the active treatment
same as in arm/group description
- Evaluation of EPA-FFA efficacy compared to placebo [ Time Frame: 28 days ]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.
- Time to and amount of clinical improvement [ Time Frame: 28 days ]To determine whether EPA-FFA gastro-resistant capsules decreases the time to and amount of clinical improvement as determined by the WHO 9-point ordinal scale during the study.
- Change in recovery and survival rate [ Time Frame: 28 days ]To determine whether EPA-FFA gastro-resistant capsules increases the number of subjects alive and discharged home without supplemental oxygen therapy.
- Reduction of CRP and IL-6 [ Time Frame: 28 days ]To determine whether EPA-FFA gastro-resistant capsules decreases CRP and IL-6 during the study.
- Increase in IFN-γ [ Time Frame: 28 days ]To determine whether EPA-FFA gastro-resistant capsules increases IFN-γ during the study
- Reduction in proinflammatory chemokines and cytokines. [ Time Frame: 28 days ]To determine whether EPA-FFA gastro-resistant capsules decreases other proinflammatory chemokines and cytokines.
- Safety - Vitals, AEs and Clinical lab parameters [ Time Frame: throughout the study, about 3 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04335032
|Contact: Justin Slagelemail@example.com|
|Hospital Universitario Vall d'Hebron||Recruiting|
|Barcelona, Spain, 119 129|
|Contact: Adrián Sánchez Montalva|
|Cottingham, United Kingdom, HU16 5JQ|
|Contact: Simon Hart|
|Coventry, United Kingdom, CV2 2DX|
|Contact: Beatriz L Gallego|
|Harrow, United Kingdom, HA1 3UJ|
|Contact: Ashley Whitington|
|Rotherham NHS Foundation Trust||Recruiting|
|Rotherham, United Kingdom, S60 2UD|
|Contact: Anil Hormis|