COVID-19Phase 2NCT04647604
Resolving Inflammatory Storm in COVID-19 Patients by Omega-3 Polyunsaturated Fatty Acids -
A Phase 2 study testing Omegaven® and Sodium chloride in people with COVID-19, run by Karolinska University Hospital at 2 sites in Sweden.
Trial summary
A study on patients who are hospitalized and tested positive for COVID-19 or have a typical CT image of COVID-19 infection, to establish if omega-3 Polyunsaturated Fatty Acid (PUFA) supplementation by intravenous route is a possible treatment option in COVID-19 with minimal risks to the patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Omegaven® and Sodium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 2 sitesSweden
- Study dates
- 23 Jun 2020to 7 Jul 2021
- Phase
- Phase 2
- 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
- Provision of signed informed consent prior to any study specific procedures.
- Female and male patients ≥18 years of age.
- COVID-19 positive or typical CT image of COVID-19 infection.
- Clinical status requiring hospitalization.
Who cannot join
- According to Omegaven® contraindications (serious bleeding disorders, acute life-threatening condition, including acute shock, acute myocardial infarction, acute stroke, acute emboli, and coma).
- Known hypersensitivity to Omegaven® or any of the ingredients.
- Participation in any clinical research study evaluating an investigational medicinal product (IMP) within 3 months prior to screening.
- Pregnancy and breastfeeding.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Karolinska Universitetssjuhuset
Stockholm
Södersjukhuset
Stockholm
About this study
Official title: Resolving Inflammatory Storm in COVID-19 Patients by Omega-3 Polyunsaturated Fatty Acids - A Single-blind, Randomized, Placebo-controlled Feasibility Study
A study on patients who are hospitalized and tested positive for COVID-19 or have a typical CT image of COVID-19 infection, to establish if omega-3 Polyunsaturated Fatty Acid (PUFA) supplementation by intravenous route is a possible treatment option in COVID-19 with minimal risks to the patients.
- Conditions
- COVID-19
- Being tested
- Omegaven®, Sodium chloride
- Keywords
- Inflammatory Storm, COVID-19 infection, Omega-3 fatty acids, Inflammatory biomarkers, Omega-3 index
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omegaven®Drug
A highly refined fish oil in an emulsion for infusion with purified egg phosphatides and glycerol.
Sodium chlorideDrug
intravenously administered 2 mL/kg/day
| Study group | Role | What they receive |
|---|---|---|
| Omega | Active comparator | Omegaven® (2 mL/kg/day, equivalent to 6 g Docosahexaenoic Acid (DHA)+Eicosapentaenoic Acid (EPA) in a 70 kg individual) once daily for 5 days Receives: Drug: Omegaven® |
| Sodium chloride (NaCl) | Placebo comparator | 2 mL/kg/day) once daily for 5 days Receives: Drug: Sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in inflammatory biomarkers
white blood cell counts
Measured: 5 days
Changes in inflammatory biomarkers
CRP
Measured: 5 days
Changes in inflammatory biomarkers
lipidomic profiling
Measured: 5 days
Changes in inflammatory biomarkers
cytokines
Measured: 5 days
Changes in inflammatory biomarkers
metabolomic profiling
Measured: 5 days
Secondary outcomes (11)
Changes in proresolving mediators
lipidomics
Measured: 5 days
Changes in fatty acids in the erythrocyte fraction
fatty acid profile
Measured: 5 days
Changes in cardiac biomarkers
Troponin, NTproBNP
Measured: 5 days
Changes in biomarkers of organ damage
LD, creatinine
Measured: 5 days
Changes in thrombosis parameters
platelet count, D-dimer,
Measured: 5 days
Changes in coagulation parameters
fibrinogen
Measured: 5 days
Changes in markers of infection
procalcitonin concentrations
Measured: 5 days
Changes in infection load
SARS-CoV2-RNAemia
Measured: 5 days
Changes in clinical parameters
National Early Warning Score (NEWS2)
Measured: through study completion, on average 10 days
Length of hospital stay
Days of hospital stay
Measured: through study completion, on average 10 days
Complications
ICU need, mortality
Measured: through study completion, on average 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start23 Jun 2020
- Primary completion5 Jan 2021
- Study completion7 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magnus Bäck, Karolinska University Hospital
- Investigators
- Magnus Bäck, Professor, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647604
- Sponsor's protocol ID
- 2020-002293-28
- Status last verified
- Jan 2022
- First submitted
- 12 Jun 2020
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported will be shared, after deidentification, with researchers who provide a methodologically sound proposal.
Publications
Arnardottir H, Pawelzik SC, Ohlund Wistbacka U, Artiach G, Hofmann R, Reinholdsson I, Braunschweig F, Tornvall P, Religa D, Back M. Stimulating the Resolution of Inflammation Through Omega-3 Polyunsaturated Fatty Acids in COVID-19: Rationale for the COVID-Omega-F Trial. Front Physiol. 2021 Jan 11;11:624657. doi: 10.3389/fphys.2020.624657. eCollection 2020.
PubMed 33505321
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resolving Inflammatory Storm in COVID-19 Patients by Omega-3 Polyunsaturated Fatty Acids - A Single-blind, Randomized, Placebo-controlled Feasibility Study
- ClinicalTrials.gov ID
- NCT04647604
- Acronym / sponsor ID
- 2020-002293-28
- Conditions
- COVID-19
- Keywords
- Inflammatory Storm, COVID-19 infection, Omega-3 fatty acids, Inflammatory biomarkers, Omega-3 index
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- 5 Jan 2021 (actual)
- Study completion
- 7 Jul 2021 (actual)
- First posted
- 1 Dec 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.
A study on patients who are hospitalized and tested positive for COVID-19 or have a typical CT image of COVID-19 infection, to establish if omega-3 Polyunsaturated Fatty Acid (PUFA) supplementation by intravenous route is a possible treatment option in COVID-19 with minimal risks to the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega | Active comparator | Drug: Omegaven®Omegaven® (2 mL/kg/day, equivalent to 6 g Docosahexaenoic Acid (DHA)+Eicosapentaenoic Acid (EPA) in a 70 kg individual) once daily for 5 days |
| Sodium chloride (NaCl) | Placebo comparator | Drug: Sodium chloride2 mL/kg/day) once daily for 5 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provision of signed informed consent prior to any study specific procedures.
- Female and male patients ≥18 years of age.
- COVID-19 positive or typical CT image of COVID-19 infection.
- Clinical status requiring hospitalization.
Key exclusion criteria (4 listed)
- According to Omegaven® contraindications (serious bleeding disorders, acute life-threatening condition, including acute shock, acute myocardial infarction, acute stroke, acute emboli, and coma).
- Known hypersensitivity to Omegaven® or any of the ingredients.
- Participation in any clinical research study evaluating an investigational medicinal product (IMP) within 3 months prior to screening.
- Pregnancy and breastfeeding.
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 |
|---|---|---|
| Omegaven®A highly refined fish oil in an emulsion for infusion with purified egg phosphatides and glycerol. | Drug | Omega |
| Sodium chlorideintravenously administered 2 mL/kg/day | Drug | Sodium chloride (NaCl) |
Primary outcome
Changes in inflammatory biomarkers
Time frame: 5 days
white blood cell counts
Changes in inflammatory biomarkers
Time frame: 5 days
CRP
Changes in inflammatory biomarkers
Time frame: 5 days
lipidomic profiling
Changes in inflammatory biomarkers
Time frame: 5 days
cytokines
Changes in inflammatory biomarkers
Time frame: 5 days
metabolomic profiling
11 secondary outcomes
Changes in proresolving mediators
Time frame: 5 days
Changes in fatty acids in the erythrocyte fraction
Time frame: 5 days
Changes in cardiac biomarkers
Time frame: 5 days
Changes in biomarkers of organ damage
Time frame: 5 days
Changes in thrombosis parameters
Time frame: 5 days
Changes in coagulation parameters
Time frame: 5 days
Changes in markers of infection
Time frame: 5 days
Changes in infection load
Time frame: 5 days
Changes in clinical parameters
Time frame: through study completion, on average 10 days
Length of hospital stay
Time frame: through study completion, on average 10 days
Complications
Time frame: through study completion, on average 10 days
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 5 Jan 2022.
- Derived from this study: PubMed 33505321Arnardottir H, Pawelzik SC, Ohlund Wistbacka U, Artiach G, Hofmann R, Reinholdsson I, Braunschweig F, Tornvall P, Religa D, Back M. Stimulating the Resolution of Inflammation Through Omega-3 Polyunsaturated Fatty Acids in COVID-19: Rationale for the COVID-Omega-F Trial. Front Physiol. 2021 Jan 11;11:624657. doi: 10.3389/fphys.2020.624657. eCollection 2020.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported will be shared, after deidentification, with researchers who provide a methodologically sound proposal.
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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.
Magnus Bäck, Professor principal investigator
Karolinska University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omegaven® and Sodium chloride in people with COVID-19, run by Karolinska University Hospital at 2 sites in Sweden.
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 4 inclusion and 4 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 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Changes in inflammatory biomarkers (time frame: 5 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04647604, which also lists 1 linked publication.
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 5 Jan 2022.