COVID19Phase 3PREPARE-ITNCT04460651
PREPARE-IT. Prevention and Treatment of COVID19 With EPA in Subjects at Risk - Intervention Trial
A Phase 3 study testing Icosapent ethyl (IPE) in people with COVID19, run by Estudios Clínicos Latino América at 1 site in Argentina.
Trial summary
The PREPARE-IT investigator-initiated trial program is a simple, pragmatic, therapeutic strategy evaluating pure icosapent ethyl (IPE) at initially higher doses intended to reduce infection rates and subsequent morbidity and mortality among subjects at high risk of infection due to COVID-19 (prevention arm), and to… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID19
- What is being tested?
- Icosapent ethyl (IPE)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,093 participants
- Where
- 1 siteArgentina
- Study dates
- 14 Aug 2020to 30 Aug 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older and
- any subject that is circulating and exposed to the public
- 40 years of age or older and
- Covid 19 diagnosis confirmed with SARS Cov-2 test (RT-PCR) and
- No more than 7 days from the onset of symptoms and
- Without clear indication for hospitalization (1-2 in the WHO COVID-19 Descriptive Score).
Who cannot join
- Previously diagnosed with COVID-19
- Positive pregnancy test at the time of study entry in potentially fertile women
- Pregnant or breastfeeding women
- Subject who has received one or more doses of any vaccine for Sars-Cov-2 or who is scheduled to be vaccinated within the next 60 days
- Unable to provide informed consent
- Clear contraindication to EPA
Show all 19Show fewer
- Known hypersensitivity to the study drug
- Administration of a drug with anticoagulant effects (antiplatelet agents are allowed)
- Hemorrhagic Diathesis
- Treatment arm:
- Hospitalized patient or with a clear indication of hospitalization for COVID-19
- Pregnant or breastfeeding women
- Lack of access to adequate means of communication via the web
- Unable to provide informed consent
- Clear contraindication to EPA
- Known hypersensitivity to the study drug
- Administration of a drug with anticoagulant effects (antiplatelet agents are allowed)
- Hemorrhagic Diathesis
- Subjects who fill out the pre-selection form will be evaluated and approved for admission to the clinical trial after confirming their entry criteria
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Instituto de Investigaciones Clínicas - Rosario
Rosario, Santa Fe Province, 2000
About this study
The PREPARE-IT investigator-initiated trial program is a simple, pragmatic, therapeutic strategy evaluating pure icosapent ethyl (IPE) at initially higher doses intended to reduce infection rates and subsequent morbidity and mortality among subjects at high risk of infection due to COVID-19 (prevention arm), and to reduce the hospitalization rate and complications in patients with a positive diagnosis of COVID-19 (treatment arm).
Read the detailed description
Few vaccines have received emergency authorization providing relative immunity, reducing both transmission and infection rates and subsequent associated morbidity and mortality. However, broad access to vaccines is limited globally, and emergence of COVID-19 viral mutations and vaccine breakthrough cases underscore the need for complementary effective therapies.
To date, there are limited systemic options available for effective treatment from viral-inhibitors, polyclonal antibodies (immunomodulatory drugs) to mitigate the inflammatory cascade and subsequent cytokine storm, and low-dose steroids such as dexamethasone in high-risk patients, which was associated with a reduction in mortality.
Icosapent ethyl (IPE) is a safe, well-tolerated oral therapy proven to be effective in improving outcomes in patients with established cardiovascular disease or diabetes with one or more additional risk factors.
In the context of COVID-19, a recent pilot study on 50 patients on a loading dose of 8g/day for three days, followed by 4g/daily showed a significant improvement in validated patient-reported FLU-PRO score symptoms. A corresponding reduction in a key biomarker of inflammation (hs-CRP) was also detected within the IPE arm at 14 days.
While this pilot study provides the first evidence of an early anti-inflammatory effect of IPE, to confirm these findings, we designed a randomized, placebo-controlled study program investigating IPE with a similar loading dose intended to reduce infection rates and subsequent morbidity and mortality among subjects at high risk of infection from SARS-CoV-2 (prevention arm), and to reduce the hospitalization rate and complications in patients with a positive diagnosis of COVID-19 (treatment arm).
- Conditions
- COVID19
- Being tested
- Icosapent ethyl (IPE), Placebo
- Keywords
- Icosapent ethyl, Vascepa, Eicosapentaenoic acid ethyl ester, Ethyl-EPA, AMR101
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Icosapent ethyl (IPE)Drug
Also called Vascepa®
Participants in this arm will receive study medication IPE with the following dosage schedule:
8 g of IPE (4 capsules every 12 hours - morning and evening, with food) for the first three days followed by 4 g of IPE (2 capsules every 12 hours - morning and evening, with food) thereafter (days 4-28 for treatment arm and 4-60 for prevention arm)
PlaceboDrug
Participants in this arm will receive placebo with the following dosage schedule: 8 g of placebo (4 capsules every 12 hours - morning and evening, with food) for the first three days followed by 4 g of placebo (2 capsules every 12 hours - morning and evening, with food) thereafter (days 4-28 for treatment arm and 4-60 for prevention arm)
| Study group | Role | What they receive |
|---|---|---|
| Active treatment | Active comparator | Participants in this arm will receive study medication icosapent ethyl (IPE) with a specific dose scheme. Receives: Drug: Icosapent ethyl (IPE) |
| Placebo | Placebo comparator | Participants in this arm will receive Placebo with the same dose scheme as the active comparator: Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
(A) Prevention Arm: SARS-CoV-2 positivity assesed up to day 60.
SARS-CoV-2 positive subjects are defined as subjects with positive tests for SARS-CoV-2 RT-PCR or for SARS-CoV-2 lgG antibodies after developing COVID-19 disease at any stage within the follow-up period (including those subjects with or without symptomatic COVID-19 evaluated before the final visit) or those individuals who test positive for SARS-CoV-2 RT-PCR or for SARS-CoV-2 lgG antibodies at the final visit (day 60).
Measured: 60 days
(B) Treatment Arm: COVID 19 related hospitalization (indication for hospitalization per the blinded investigator or actual hospitalization) or death assessed up to 28 days
Measured: 28 days
Secondary outcomes (10)
(A) Prevention Arm: High-sensitivity C-reactive Protein (mg/dL) change from baseline to day 60 (key secondary outcome)
Mean change from baseline will be computed
Measured: baseline, 60 days
(A) Prevention Arm: Triglycerides (mg/dL) change from baseline to day 60
Mean change from baseline will be computed
Measured: baseline, 60 days
(A) Prevention Arm: FLU-PRO SCORE change from baseline to day 60 in a subset of subjects
Mean change from baseline will be computed
Measured: baseline, 60 days
(B) Treatment Arm: COVID 19 related hospitalization or death assessed up to 28 days (key secondary outcome)
Measured: 28 days
(B) Treatment Arm: Alive and out of the hospital at 28 days.
Measured: 28 days
(B) Treatment Arm: In hospital length of stay assessed up to 28 days
Measured: 28 days
(B) Treatment Arm: New requirement of mechanical ventilation assed up to 28 days.
Measured: 28 days
(B) Treatment Arm: Total events: non-fatal myocardial infarction or non-fatal stroke or death (initial and subsequent), until day 28.
Measured: 28 days
(B) Treatment Arm: Total mortality assessed up to 28 days
Measured: 28 days
(B) Treatment Arm: FLU-PRO SCORE change from baseline at 28 days
Measured: (B) Treatment Arm:
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start14 Aug 2020
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID19Studies 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
- Model description
- Simple, pragmatic, double-blind, placebo-controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 4,093 participants (actual)
Sponsor and investigators
- Lead sponsor
- Estudios Clínicos Latino América
- Sponsor type
- University, hospital or other
- Collaborators
- Amarin Pharma Inc.
- Responsible party
- Sponsor
- Investigators
- Rafael Diaz, MD, Principal investigator, ECLA- Estudios Clínicos Latino América
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460651
- Sponsor's protocol ID
- PREPARE-IT. Version 4.0
- Acronym
- PREPARE-IT
- Status last verified
- Aug 2021
- First submitted
- 2 Jul 2020
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREPARE-IT. Prevention and Treatment of COVID19 With EPA in Subjects at Risk - Intervention Trial
- ClinicalTrials.gov ID
- NCT04460651
- Acronym / sponsor ID
- PREPARE-IT / PREPARE-IT. Version 4.0
- Conditions
- COVID19
- Keywords
- Icosapent ethyl, Vascepa, Eicosapentaenoic acid ethyl ester, Ethyl-EPA, AMR101
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,093 participants (actual)
- Lead sponsor
- Estudios Clínicos Latino AméricaUniversity, hospital or other
- Collaborators
- Amarin Pharma Inc.
- Study start
- 14 Aug 2020 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 7 Jul 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.
The PREPARE-IT investigator-initiated trial program is a simple, pragmatic, therapeutic strategy evaluating pure icosapent ethyl (IPE) at initially higher doses intended to reduce infection rates and subsequent morbidity and mortality among subjects at high risk of infection due to COVID-19 (prevention arm), and to reduce the hospitalization rate and complications in patients with a positive diagnosis of COVID-19 (treatment arm).
Detailed description
Few vaccines have received emergency authorization providing relative immunity, reducing both transmission and infection rates and subsequent associated morbidity and mortality. However, broad access to vaccines is limited globally, and emergence of COVID-19 viral mutations and vaccine breakthrough cases underscore the need for complementary effective therapies.
To date, there are limited systemic options available for effective treatment from viral-inhibitors, polyclonal antibodies (immunomodulatory drugs) to mitigate the inflammatory cascade and subsequent cytokine storm, and low-dose steroids such as dexamethasone in high-risk patients, which was associated with a reduction in mortality.
Icosapent ethyl (IPE) is a safe, well-tolerated oral therapy proven to be effective in improving outcomes in patients with established cardiovascular disease or diabetes with one or more additional risk factors.
In the context of COVID-19, a recent pilot study on 50 patients on a loading dose of 8g/day for three days, followed by 4g/daily showed a significant improvement in validated patient-reported FLU-PRO score symptoms. A corresponding reduction in a key biomarker of inflammation (hs-CRP) was also detected within the IPE arm at 14 days.
While this pilot study provides the first evidence of an early anti-inflammatory effect of IPE, to confirm these findings, we designed a randomized, placebo-controlled study program investigating IPE with a similar loading dose intended to reduce infection rates and subsequent morbidity and mortality among subjects at high risk of infection from SARS-CoV-2 (prevention arm), and to reduce the hospitalization rate and complications in patients with a positive diagnosis of COVID-19 (treatment arm).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Simple, pragmatic, double-blind, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Active treatment | Active comparator | Drug: Icosapent ethyl (IPE)Participants in this arm will receive study medication icosapent ethyl (IPE) with a specific dose scheme. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants in this arm will receive Placebo with the same dose scheme as the active comparator: |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older and
- any subject that is circulating and exposed to the public
- 40 years of age or older and
- Covid 19 diagnosis confirmed with SARS Cov-2 test (RT-PCR) and
- No more than 7 days from the onset of symptoms and
Key exclusion criteria (19 listed)
- Previously diagnosed with COVID-19
- Positive pregnancy test at the time of study entry in potentially fertile women
- Pregnant or breastfeeding women
- Subject who has received one or more doses of any vaccine for Sars-Cov-2 or who is scheduled to be vaccinated within the next 60 days
- Unable to provide informed consent
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 |
|---|---|---|
| Icosapent ethyl (IPE)Also: Vascepa®Participants in this arm will receive study medication IPE with the following dosage schedule: 8 g of IPE (4 capsules every 12 hours - morning and evening, with food) for the first three days followed by 4 g of IPE (2 capsules every 12 hours - morning and evening, with food) thereafter (days 4-28 for treatment arm and 4-60 for prevention arm) | Drug | Active treatment |
| PlaceboParticipants in this arm will receive placebo with the following dosage schedule: 8 g of placebo (4 capsules every 12 hours - morning and evening, with food) for the first three days followed by 4 g of placebo (2 capsules every 12 hours - morning and evening, with food) thereafter (days 4-28 for treatment arm and 4-60 for prevention arm) | Drug | Placebo |
Primary outcome
(A) Prevention Arm: SARS-CoV-2 positivity assesed up to day 60.
Time frame: 60 days
SARS-CoV-2 positive subjects are defined as subjects with positive tests for SARS-CoV-2 RT-PCR or for SARS-CoV-2 lgG antibodies after developing COVID-19 disease at any stage within the follow-up period (including those subjects with or without symptomatic COVID-19 evaluated before the final visit) or those individuals who test positive for SARS-CoV-2 RT-PCR or for SARS-CoV-2 lgG antibodies at the final visit (day 60).
(B) Treatment Arm: COVID 19 related hospitalization (indication for hospitalization per the blinded investigator or actual hospitalization) or death assessed up to 28 days
Time frame: 28 days
10 secondary outcomes
(A) Prevention Arm: High-sensitivity C-reactive Protein (mg/dL) change from baseline to day 60 (key secondary outcome)
Time frame: baseline, 60 days
(A) Prevention Arm: Triglycerides (mg/dL) change from baseline to day 60
Time frame: baseline, 60 days
(A) Prevention Arm: FLU-PRO SCORE change from baseline to day 60 in a subset of subjects
Time frame: baseline, 60 days
(B) Treatment Arm: COVID 19 related hospitalization or death assessed up to 28 days (key secondary outcome)
Time frame: 28 days
(B) Treatment Arm: Alive and out of the hospital at 28 days.
Time frame: 28 days
(B) Treatment Arm: In hospital length of stay assessed up to 28 days
Time frame: 28 days
(B) Treatment Arm: New requirement of mechanical ventilation assed up to 28 days.
Time frame: 28 days
(B) Treatment Arm: Total events: non-fatal myocardial infarction or non-fatal stroke or death (initial and subsequent), until day 28.
Time frame: 28 days
(B) Treatment Arm: Total mortality assessed up to 28 days
Time frame: 28 days
(B) Treatment Arm: FLU-PRO SCORE change from baseline at 28 days
Time frame: (B) Treatment Arm:
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 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.
Rafael Diaz, MD principal investigator
ECLA- Estudios Clínicos Latino América
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Icosapent ethyl (IPE) in people with COVID19, run by Estudios Clínicos Latino América at 1 site in Argentina.
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 19 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: finished, as of the sponsor's last update on 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(A) Prevention Arm: SARS-CoV-2 positivity assesed up to day 60. (time frame: 60 days). The study lists 2 primary outcomes in all. 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 17 Sep 2021.