COVID-19 InfectionPhase 4PRODEXNCT04350086
Use of Dexmedetomidine in Light to Moderate Sedation in the Patient in the Palliative Situation of a Sars-cov-2 / COVID-19 Infection
A Phase 4 study testing Treatment with Dexmedetomidine in people with COVID-19 Infection and Sars-cov-2, run by University Hospital, Limoges at 1 site in France.
Trial summary
The current sars-cov-2 epidemic is responsible for severe respiratory infections leading to end-of-life situations. Dexmedetomidine may be indicated in mild to moderate sedation in palliative patients, due to its pharmacological characteristics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Infection, Sars-cov-2, Respiratory Failure
- What is being tested?
- Treatment with Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 20 Apr 2020to 20 Nov 2020
- 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
- Major patient
- Relating to palliative care
- With sars-cov-2 infection
- Requiring light to moderate sedation corresponding to a RASS score of -1 to -3
Who cannot join
- Pregnant, lactating woman.
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the summary of product characteristics
- Advanced heart block (level 2 or 3) unless a pacemaker.
- Uncontrolled hypotension.
- Acute cerebrovascular pathologies.
- Use of other sedative drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study of the Use of Dexmedetomidine in Light to Moderate Sedation in the Patient in the Palliative Situation of a Sars-cov-2 / COVID-19 Infection
The current sars-cov-2 epidemic is responsible for severe respiratory infections leading to end-of-life situations.
Dexmedetomidine may be indicated in mild to moderate sedation in palliative patients, due to its pharmacological characteristics.
The hypothesis of this study is that Dexmedetomidine would allow effective and safe light sedation in patients with respiratory failure in palliative situations suffering from Covid-19 infection.
- Being tested
- Treatment with Dexmedetomidine
- Keywords
- COVID-19, sars-cov-2, infection, respiratory failure, palliative situation
- Medical subject headings
- COVID-19, Respiratory Insufficiency, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with DexmedetomidineDrug
Administration of Dexmedetomidine in continuous infusion by electric syringe pump at a dose of 0.4 µg / kg / h, with dose adjustment according to the sedation score and tolerance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Not described Receives: Drug: Treatment with Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of mild to moderate palliative sedation induced by Dexmedetomidine.
Number of days of mild to moderate sedation induced by dexmedetomidine until death or change of molecule.
Measured: Day 30
Secondary outcomes (4)
Overall survival of patients on Dexmedetomidine
Overall survival time in days from inclusion.
Measured: Day 30
Daily analgesic effect of Dexmedetomidine
The daily effectiveness of Dexmedetomidine on pain assessed by the NCS-R scale (Nociception Coma Scale) : the score is between 0 and 9.
Measured: Day 30
Other sedative pharmacological agents
Number of the various sedative molecules used in the subjects of the study in addition to Dexmedetomidine.
Measured: Day 30
Average dosage required for Dexmedetomidine to achieve mild to moderate sedation
Daily dosage measurement in ug / kg / h of Dexmedetomidine necessary to obtain light to moderate sedation
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start20 Apr 2020 (estimated)
- Primary completion20 Nov 2020 (estimated)
- Study completion20 Nov 2020 (estimated)
Why it stopped: unfavorable opinion of the ethics committee
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04350086
- Sponsor's protocol ID
- 87RI20_0011 (PRODEX)
- Acronym
- PRODEX
- Status last verified
- Apr 2020
- First submitted
- 13 Apr 2020
- Last updated
- 2 Sep 2020
- 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 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of the Use of Dexmedetomidine in Light to Moderate Sedation in the Patient in the Palliative Situation of a Sars-cov-2 / COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04350086
- Acronym / sponsor ID
- PRODEX / 87RI20_0011 (PRODEX)
- Keywords
- COVID-19, sars-cov-2, infection, respiratory failure, palliative situation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unfavorable opinion of the ethics committee
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 20 Apr 2020 (estimated)
- Primary completion
- 20 Nov 2020 (estimated)
- Study completion
- 20 Nov 2020 (estimated)
- First posted
- 16 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 current sars-cov-2 epidemic is responsible for severe respiratory infections leading to end-of-life situations.
Dexmedetomidine may be indicated in mild to moderate sedation in palliative patients, due to its pharmacological characteristics.
The hypothesis of this study is that Dexmedetomidine would allow effective and safe light sedation in patients with respiratory failure in palliative situations suffering from Covid-19 infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: Treatment with Dexmedetomidine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Major patient
- Relating to palliative care
- With sars-cov-2 infection
- Requiring light to moderate sedation corresponding to a RASS score of -1 to -3
Key exclusion criteria (6 listed)
- Pregnant, lactating woman.
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the summary of product characteristics
- Advanced heart block (level 2 or 3) unless a pacemaker.
- Uncontrolled hypotension.
- Acute cerebrovascular pathologies.
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 |
|---|---|---|
| Treatment with DexmedetomidineAdministration of Dexmedetomidine in continuous infusion by electric syringe pump at a dose of 0.4 µg / kg / h, with dose adjustment according to the sedation score and tolerance. | Drug | Experimental arm |
Primary outcome
Efficacy of mild to moderate palliative sedation induced by Dexmedetomidine.
Time frame: Day 30
Number of days of mild to moderate sedation induced by dexmedetomidine until death or change of molecule.
4 secondary outcomes
Overall survival of patients on Dexmedetomidine
Time frame: Day 30
Daily analgesic effect of Dexmedetomidine
Time frame: Day 30
Other sedative pharmacological agents
Time frame: Day 30
Average dosage required for Dexmedetomidine to achieve mild to moderate sedation
Time frame: Day 30
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 2 Sep 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Treatment with Dexmedetomidine in people with COVID-19 Infection and Sars-cov-2, run by University Hospital, Limoges at 1 site in France.
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 6 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 2 Sep 2020. 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 France. 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?
Efficacy of mild to moderate palliative sedation induced by Dexmedetomidine. (time frame: Day 30). 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 2 Sep 2020.