EPA-FFA to treat hospitalised patients with SARS-CoV-2 [COVID-19]
Research type
Research Study
Full 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
IRAS ID
282222
Contact name
Beatriz Lara Gallego
Contact email
Sponsor organisation
SLA Pharma (UK) Ltd
Eudract number
2020-001396-33
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 7 months, 0 days
Research summary
The Covid-19 infection is characterized by a very strong inflammatory response of the body and often results in a “Covid-19 pneumonia”, similar to what is known as Acute Respiratory Distress Syndrome (ARDS). Drug therapies that moderate inflammation in ARDS/Covid-19 pneumonia are lacking.
By providing this medication to patients visiting a hospital emergency department or admitted to hospital aged over 18 with SARS-CoV-2 (COVID-19 infection) we want to show that 2 capsules of Eicosapentaenoic acid (EPA-FFA) taken twice a day can reduce the negative effects of the disease, and reduce the fatality rate compared to current standard of care.
Details relating to the mechanisms of Covid-19 infection are limited. It is known however, that Covid-19 infection causes severe inflammation, triggering the release of high amounts of inflammatory molecules, many of which can cause damage to healthy cells. Additionally, at the late stage of the disease, formation of new blood vessels has been seen to be a crucial step of lung tissue damage, potentially leading to a fatal ARDS condition.
Eicosapentaenoic acid (EPA) is a natural molecule found in oily fish. The effects of omega-3 fatty acids, in particular EPA (the active ingredient of this study medication), on the many different inflammatory pathways have been well studied. Due to the competitive nature of signalling molecules, it is well documented that a high concentration of EPA promotes the production of anti-inflammatory molecules, reducing the intensity of inflammatory attacks.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
20/SC/0418
Date of REC Opinion
13 Nov 2020
REC opinion
Further Information Favourable Opinion