EPA-FFA to Treat Hospitalised Patients With COVID-19 (SARS-CoV-2)
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|ClinicalTrials.gov Identifier: NCT04335032|
Recruitment Status : Recruiting
First Posted : April 6, 2020
Last Update Posted : December 3, 2021
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|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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
The subject must satisfy the following criteria for entry into the study:
- Male or female, aged 18 years and above.
- Provide informed consent prior to any study specific procedure being conducted; for older patients who lack mental or physical capacity, next of kin or legal guardians will be allowed to provide consent on their behalf. This consent can be obtained remotely by telephone to the next of kin, or by a doctor with relevant experience in COVID-19 disease not directly involved in the study acting as the patient's advocate and then subsequently informing the next of kin (eg by a telephone call also offering them an opportunity to review and agree the ICF with them; the patient may then continue in the study or withdraw at a later date if the next of kin subsequently decides to withdraw consent).
- Positive local approved test to confirm diagnosis of SARS-CoV-2 within 7 days prior to baseline.
- Classified as moderate or severe based on the modified WHO/NIH baseline severity criteria. Moderate: evidence of lower respiratory disease by clinical assessment (e.g. signs or symptoms of lung infection) or by chest X-ray/CT/ultrasound imaging (e.g. viral pneumonia, lung infiltrates) and a saturation of oxygen (SaO2) ≥ 94% on room air at sea level. Severe: respiratory frequency >30 bpm, SaO2 < 94% on room air at sea level, ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) < 300 mmHg, or lung infiltrates >50%.
- Hospitalised or attended the hospital ED due to clinical and/or virological diagnosis of SARS-CoV-2; subsequent follow up after screening may be carried out in hospital (hospitalised) or at a COVID-19 hospital OP clinic as clinically indicated at the investigator's discretion. Where it is not possible for the subject to attend a hospital OP clinic, then providing a suitably trained healthcare professional (eg part of the clinical research team) as directed by the investigator, is available to visit the subject at home to conduct the necessary clinical and SaO2 assessments and blood tests, subsequent assessments post-hospitalisation or ED visit may be conducted at the subject's home.
The subject will be excluded from the study if any of the following applies:
- No symptoms or signs or lung imaging abnormalities of SARS-CoV-2.
- On or clinically diagnosed as requiring intubation at screening.
- On or clinically diagnosed as requiring mechanical ventilation at screening.
- On or clinically diagnosed as requiring oxygen delivered by high flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates > 20 L/min with fraction of delivered oxygen ≥ 0.5).
- On or clinically diagnosed as requiring noninvasive positive pressure ventilation.
- On or clinically diagnosed as requiring extracorporeal membrane oxygenation (ECMO).
- Unable to swallow study capsules easily.
- Known allergic reaction or intolerant to fish or fish oils.
- Known allergic reaction to excipients of IMP.
- Pregnant or breast-feeding at screening.
- Taking other fish-oil supplements (e.g. cod liver oil) who are unwilling to stop them for the duration of the study.
- Taking immunomodulators/immunosuppressants, including corticosteroids on entry into the study.
- Used another investigational drug in the past 48 hours or 5 half-lives, whichever is longer, prior to Screening.
- Participating in other clinical studies at the same time.
- Evidence of multi-organ failure, SOFA score > 9.
- Deemed, by the investigator, unlikely to be able to comply with the requirements of the protocol.
- Deemed, by the investigator, likely to require transfer to the intensive care unit (ICU) or unlikely to survive for at least 48 hours.
- Any gastro-intestinal symptoms at screening considered clinically significant.
- Clinically significant abnormalities, which in the opinion of the investigator would significantly risk the safety of the subject or the main objectives of the study.
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|
|Responsible Party:||S.L.A. Pharma AG|
|Other Study ID Numbers:||
|First Posted:||April 6, 2020 Key Record Dates|
|Last Update Posted:||December 3, 2021|
|Last Verified:||November 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|