SARS-CoV-2Phase 3NCT04335032
EPA-FFA to Treat Hospitalised Patients With COVID-19 (SARS-CoV-2)
A Phase 3 study testing Eicosapentaenoic acid gastro-resistant capsules in people with SARS-CoV-2, run by S.L.A. Pharma AG at 5 sites in 2 countries.
Trial summary
This is an double-blind, randomized, placebo controlled phase III study in hospitalized subjects with confirmed SARS-CoV-2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- Eicosapentaenoic acid gastro-resistant capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 284 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 8 Jan 2021to 1 Dec 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United Kingdom4 sites, 4 recruiting
- Recruiting
Hull
Cottingham, HU16 5JQ
Simon Hart
- Recruiting
UHCW
Coventry, CV2 2DX
Beatriz L Gallego
- Recruiting
NPH
Harrow, HA1 3UJ
Ashley Whitington
- Recruiting
Rotherham NHS Foundation Trust
Rotherham, S60 2UD
Anil Hormis
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Vall d'Hebron
Barcelona, 119 129
Adrián Sánchez Montalva
About this study
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
This is an double-blind, randomized, placebo controlled phase III study in hospitalized subjects with confirmed SARS-CoV-2.
Read the 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.
- Conditions
- SARS-CoV-2
- Being tested
- Eicosapentaenoic acid gastro-resistant capsules, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eicosapentaenoic acid gastro-resistant capsulesDrug
Also called Alfa
same as in arm/group description
PlaceboDrug
same as in arm/group description
| Study group | Role | What they receive |
|---|---|---|
| Eicosapentaenoic acid gastro-resistant capsules | Experimental | 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. Receives: Drug: Eicosapentaenoic acid gastro-resistant capsules |
| Placebo | Placebo comparator | Placebo capsules that cannot be visually differentiated from the active treatment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation 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.
Measured: 28 days
Secondary outcomes (5)
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.
Measured: 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.
Measured: 28 days
Reduction of CRP and IL-6
To determine whether EPA-FFA gastro-resistant capsules decreases CRP and IL-6 during the study.
Measured: 28 days
Increase in IFN-γ
To determine whether EPA-FFA gastro-resistant capsules increases IFN-γ during the study
Measured: 28 days
Reduction in proinflammatory chemokines and cytokines.
To determine whether EPA-FFA gastro-resistant capsules decreases other proinflammatory chemokines and cytokines.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start8 Jan 2021
- Primary completion30 Nov 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 284 participants (estimated)
Sponsor and investigators
- Lead sponsor
- S.L.A. Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335032
- Sponsor's protocol ID
- EPA-COV-001
- Status last verified
- Nov 2021
- First submitted
- 1 Apr 2020
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04335032
- Acronym / sponsor ID
- EPA-COV-001
- Conditions
- SARS-CoV-2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 284 participants (estimated)
- Lead sponsor
- S.L.A. Pharma AGIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 6 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eicosapentaenoic acid gastro-resistant capsules | Experimental | Drug: Eicosapentaenoic acid gastro-resistant capsulesEicosapentaenoic 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. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsules that cannot be visually differentiated from the active treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eicosapentaenoic acid gastro-resistant capsulesAlso: Alfasame as in arm/group description | Drug | Eicosapentaenoic acid gastro-resistant capsules |
| Placebosame as in arm/group description | Drug | Placebo |
Primary outcome
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.
5 secondary outcomes
Time to and amount of clinical improvement
Time frame: 28 days
Change in recovery and survival rate
Time frame: 28 days
Reduction of CRP and IL-6
Time frame: 28 days
Increase in IFN-γ
Time frame: 28 days
Reduction in proinflammatory chemokines and cytokines.
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eicosapentaenoic acid gastro-resistant capsules in people with SARS-CoV-2, run by S.L.A. Pharma AG at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Justin Slagel (01923681001, jslagel@slapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of EPA-FFA efficacy compared to placebo (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2021.