CoronavirusPhase 4LIBERATENCT04334629
LIBERATE Trial in COVID-19
A Phase 4 study testing Ibuprofen in people with Coronavirus and Respiratory Distress Syndrome, run by King's College London at 1 site in United Kingdom.
Trial summary
The study aims to evaluate the reduction in severity and progression of lung injury with three doses of lipid ibuprofen in patients with SARS-CoV-2 infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus, Respiratory Distress Syndrome, SARS-CoV Infection
- What is being tested?
- Ibuprofen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 May 2020to 25 Sep 2021
- Phase
- Phase 4
- 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
- Male or female patients aged 18 years and above;
- Hospitalised;
- Confirmed or suspected SARS-CoV-2 infection;
- National Early Warning Score (NEWS2) greater than or equal to 3 in a single parameter or NEWS2 > 5 overall;
- Acute hypoxemic respiratory failure: PaO2/FiO2 ratio less than or equal to 300 OR SpO2/FiO2 ratio < 315 (Kigali Modification)
- Provision of written informed consent by the patient OR by the patient's Legal Representative OR professional consultee.
Who cannot join
- Any of the following contraindications to ibuprofen:
- A known hypersensitivity to ibuprofen or any other constituent of the medicinal product;
- Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs);
- Patients with a history of, or existing gastrointestinal ulceration/perforation or bleeding, including that associated with NSAIDs;
- Patients with severe hepatic failure;
- Patients with acute renal failure;
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- Patients with severe heart failure.
- Participation in any other investigational drug products less than 30 days prior to study enrolment;
- Glasgow Coma Score < 12;
- Patients who cannot swallow oral capsules;
- Pregnant or lactating women;
- Any medical history that might, in the opinion of the attending clinician, put the patient at significant risk if he/she were to participate in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lipid Ibuprofen Versus Standard of Care for Acute Hypoxemic Respiratory Failure Due to COVID-19: a Multicentre, Randomised, Controlled Trial
The study aims to evaluate the reduction in severity and progression of lung injury with three doses of lipid ibuprofen in patients with SARS-CoV-2 infections.
- Being tested
- Ibuprofen
- Medical subject headings
- Coronavirus Infections, Respiratory Distress Syndrome, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Also called Flarin
Lipid ibuprofen 200 mg
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | Not described |
| Standard of care plus lipid ibuprofen | Experimental | Not described Receives: Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease progression
Worsening respiratory failure; defined using severity of hypoxaemia using [PaO2/FiO2 ratio OR SpO2/FiO2 ratio]
Measured: 14 days
Time to mechanical ventilation
Time to mechanical ventilation (or need of)
Measured: 14 days
Secondary outcomes (7)
Overall survival
Measured: 28 days
Reduction in proportion of patients who require ventilation
Measured: 28 days
Reduction in length of Critical Care stay
Measured: 28 days
Reduction in length of Hospital stay
Measured: 28 days
Modulation of serum pro- and anti-inflammatory cytokines
Measured: 28 days
Reduction in duration of ventilation
Measured: 28 days
Increase in ventilator-free days
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 start26 May 2020
- Primary completion25 May 2021
- Study completion25 Sep 2021
Why it stopped: Study withdrawn.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoronavirusStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Beale, MD, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04334629
- Sponsor's protocol ID
- 282009
- Acronym
- LIBERATE
- Status last verified
- May 2020
- First submitted
- 2 Apr 2020
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipid Ibuprofen Versus Standard of Care for Acute Hypoxemic Respiratory Failure Due to COVID-19: a Multicentre, Randomised, Controlled Trial
- ClinicalTrials.gov ID
- NCT04334629
- Acronym / sponsor ID
- LIBERATE / 282009
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 26 May 2020 (actual)
- Primary completion
- 25 May 2021 (actual)
- Study completion
- 25 Sep 2021 (actual)
- 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.
The study aims to evaluate the reduction in severity and progression of lung injury with three doses of lipid ibuprofen in patients with SARS-CoV-2 infections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | – |
| Standard of care plus lipid ibuprofen | Experimental | Drug: Ibuprofen |
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 patients aged 18 years and above;
- Hospitalised;
- Confirmed or suspected SARS-CoV-2 infection;
- National Early Warning Score (NEWS2) greater than or equal to 3 in a single parameter or NEWS2 > 5 overall;
- Acute hypoxemic respiratory failure: PaO2/FiO2 ratio less than or equal to 300 OR SpO2/FiO2 ratio < 315 (Kigali Modification)
Key exclusion criteria (12 listed)
- Any of the following contraindications to ibuprofen:
- Participation in any other investigational drug products less than 30 days prior to study enrolment;
- Glasgow Coma Score < 12;
- Patients who cannot swallow oral capsules;
- Pregnant or lactating women;
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 |
|---|---|---|
| IbuprofenAlso: FlarinLipid ibuprofen 200 mg | Drug | Standard of care plus lipid ibuprofen |
Primary outcome
Disease progression
Time frame: 14 days
Worsening respiratory failure; defined using severity of hypoxaemia using [PaO2/FiO2 ratio OR SpO2/FiO2 ratio]
Time to mechanical ventilation
Time frame: 14 days
Time to mechanical ventilation (or need of)
7 secondary outcomes
Overall survival
Time frame: 28 days
Reduction in proportion of patients who require ventilation
Time frame: 28 days
Reduction in length of Critical Care stay
Time frame: 28 days
Reduction in length of Hospital stay
Time frame: 28 days
Modulation of serum pro- and anti-inflammatory cytokines
Time frame: 28 days
Reduction in duration of ventilation
Time frame: 28 days
Increase in ventilator-free days
Time frame: 28 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Individual participant dataSharing planned: Undecided
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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.
Richard Beale, MD principal investigator
Guy's and St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ibuprofen in people with Coronavirus and Respiratory Distress Syndrome, run by King's College London at 1 site in United Kingdom.
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 12 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: withdrawn, as of the sponsor's last update on 25 Jul 2023. 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 United Kingdom. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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?
Disease progression (time frame: 14 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 25 Jul 2023.