EPA-FFA to Treat Hospitalised Patients With COVID-19 (SARS-CoV-2)
- Conditions
- SARS-CoV-2
- Interventions
- Drug: PlaceboDrug: Eicosapentaenoic acid gastro-resistant capsules
- Registration Number
- NCT04335032
- Lead Sponsor
- S.L.A. Pharma AG
- Brief Summary
This is an double-blind, randomized, placebo controlled phase III study in hospitalized subjects with confirmed SARS-CoV-2.
- Detailed Description
Recruitment SSubjects hospitalised or attended the hospital ED with a confirmed diagnosis of SARS-CoV-2, will be contacted.
Potential subjects will have the opportunity to ask any questions to the researchers.
A member of the research team will provide a copy of the information sheet to the subject, who will have the opportunity to ask any questions to the researchers.
Subjects expressing an interest in participating will be interviewed to explain the study in detail, and discuss the risks, benefits, goals and limitations of the study.
Screening Procedures. Potentially eligible subjects will provide informed consent prior to any study specific procedures being conducted.
Following the provision of informed consent, the subject's demographics and medical history especially that relating to SARS-CoV-2 will be documented.
A physical examination and checks on vital signs (BP, pulse, temperature, respiration) will be conducted. Female subjects of child-bearing potential will undergo a urine pregnancy test. A blood sample will be drawn for routine haematology and biochemistry. Subjects will undergo tests for oxygen saturation, PaO2/FiO2 and interleukin-6 (IL-6).
Subjects will be asked to provide details of any concomitant medications. Subjects with confirmed diagnosis of SARS-CoV-2, compliance with the inclusion and exclusion criteria and providing informed consent will be registered on the e-CRF to obtain a randomisation number.
Baseline/Randomisation A physical examination and checks on vital signs (BP, pulse, temperature, respiration) will be conducted. Subjects will undergo tests for oxygen saturation, PaO2/FiO2 and interleukin-6. Haematology and biochemistry test (from screening) results will be confirmed as being acceptable.
The study centre will dispense the IMP under blinded conditions according to a permuted block randomisation sequence (1:1 ratio for the two subject groups).
The subjects will be trained on the dosing and asked to administer two capsules twice daily for 4 weeks. Subjects will then be provided with IMP on a daily basis by a suitably qualified and delegated member of the Investigator's team, for the duration of the treatment phase.
Treatment Phase (Week 1-3) All subjects will receive standard of care treatment throughout the treatment phase on a day to day basis. This will include assessment of additional or alternative medication required for the treatment of SARS-CoV-2, requirement for intubation and invasive ventilation, requirement to transfer to intensive care unit or death.
On a weekly basis, a physical examination and checks on vital signs (BP, pulse, temperature, respiration) will be conducted. Subjects will undergo tests for oxygen saturation, PaO2/FiO2 and IL-6.
Subjects will be asked to provide details of any concomitant medications and changes in condition via adverse event (AE) query.
Week 4 A physical examination and checks on vital signs (BP, pulse, temperature, respiration) will be conducted. Subjects will undergo tests for oxygen saturation, PaO2/FiO2 and IL-6. Female subjects of child-bearing potential will undergo a urine pregnancy test. A blood sample will be drawn for routine haematology and biochemistry. Subjects will be asked to provide details of any concomitant medications and changes in condition via AE query.
Week 6 (Follow -up) 6 weeks after randomisation (or two weeks after early withdrawal), the subject will be contacted to check the occurrence of any other adverse events and review of medications. Haematology and biochemistry test (from week 4) results will be confirmed as being acceptable.
Adverse events will be assessed by spontaneous reports by subjects.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 284
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo capsules that cannot be visually differentiated from the active treatment Eicosapentaenoic acid gastro-resistant capsules 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.
- Primary Outcome Measures
Name Time Method Evaluation of EPA-FFA efficacy compared to placebo 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.
- Secondary Outcome Measures
Name Time Method Time to and amount of clinical improvement 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 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 28 days To determine whether EPA-FFA gastro-resistant capsules decreases CRP and IL-6 during the study.
Increase in IFN-γ 28 days To determine whether EPA-FFA gastro-resistant capsules increases IFN-γ during the study
Reduction in proinflammatory chemokines and cytokines. 28 days To determine whether EPA-FFA gastro-resistant capsules decreases other proinflammatory chemokines and cytokines.
Trial Locations
- Locations (5)
Hospital Universitario Vall d'Hebron
🇪🇸Barcelona, Spain
Hull
🇬🇧Cottingham, United Kingdom
UHCW
🇬🇧Coventry, United Kingdom
NPH
🇬🇧Harrow, United Kingdom
Rotherham NHS Foundation Trust
🇬🇧Rotherham, United Kingdom