This is an double-blind, randomized, placebo controlled phase III study in hospitalized subjects with confirmed SARS-CoV-2.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
284
same as in arm/group description
same as in arm/group description
Hospital Universitario Vall d'Hebron
Barcelona, Spain
RECRUITINGHull
Cottingham, United Kingdom
RECRUITINGUHCW
Coventry, United Kingdom
RECRUITINGEvaluation of EPA-FFA efficacy compared to placebo
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 frame: 28 days
Time to and amount of clinical improvement
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.
Time frame: 28 days
Change in recovery and survival rate
To determine whether EPA-FFA gastro-resistant capsules increases the number of subjects alive and discharged home without supplemental oxygen therapy.
Time frame: 28 days
Reduction of CRP and IL-6
To determine whether EPA-FFA gastro-resistant capsules decreases CRP and IL-6 during the study.
Time frame: 28 days
Increase in IFN-γ
To determine whether EPA-FFA gastro-resistant capsules increases IFN-γ during the study
Time frame: 28 days
Reduction in proinflammatory chemokines and cytokines.
To determine whether EPA-FFA gastro-resistant capsules decreases other proinflammatory chemokines and cytokines.
Time frame: 28 days
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NPH
Harrow, United Kingdom
RECRUITINGRotherham NHS Foundation Trust
Rotherham, United Kingdom
RECRUITING