SARS-CoV 2DEXDO-COVIDNCT04413864
Immunomodulatory Profile of Dexmedetomidine Sedation in Patients Recovering After ARDS Covid-19
A study testing Inflammatory cytokines and chemokines profiles of patients with dexmedetomidine administration in people with SARS-CoV 2, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Covid-19 infection is due to SARS-CoV-2 member of the Coronavirus family represented by SARS- and MERS-CoVwith neuronal tropism capacity for the brainstem and thalami. Dexmedetomidine has(i) central antihypertensive (ii) sedative and (iii) neuroprotective properties and is often used during patient recovering after… 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?
- Inflammatory cytokines and chemokines profiles of patients with dexmedetomidine administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 24 Apr 2020to 24 Oct 2022
- Phase
- Interventional
- 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
- Patient ≥ 18 years at time of inclusion
- Hospitalized in intensive care unit (ICU)
- Administration of dexmedetomidine scheduled for 7 days
- Intubated/ventilated patient infected with SARS-CoV-2 (Covid-19 positive patient)
- Patient affiliated to a social security system (French State medical aid excluded)
- Hemoglobin level ≥ 9 g /dL
- Patient or parent / close / trusted person having been informed about the study and having given informed consent (or inclusion procedure in an emergency situation)
Who cannot join
- Protected major (under safeguardship, curatorship or guardianship)
- Pregnancy or breastfeeding
- Contra-indication to dexmedetomidine administration
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Intensive Care Unit and Respiratory division ; Groupe hospitalier Pitie-Salpetriere and Universite Pierre et Marie Curie Paris 6
Paris, 75013
Alexandre Demoule, Md, PhD, + 33 1 42 16 77 61
Alexandre Demoule, MD, PhD
About this study
Covid-19 infection is due to SARS-CoV-2 member of the Coronavirus family represented by SARS- and MERS-CoVwith neuronal tropism capacity for the brainstem and thalami. Dexmedetomidine has(i) central antihypertensive (ii) sedative and (iii) neuroprotective properties and is often used during patient recovering after mechanical ventilation withdrawal.
Dexmedetomidine administration could change the immunomodulatory profile of Covid-19 patients and reduce inflammatory response.CAM-ICU scores and Blood samples from Covid-19 ICU patients will be collected at 4 different timepoints (before Dexmedetomidine administration, at D2, D7 and M6) to analyse the inflammatory profile with different approaches:i) chromatin accessibility, ii) transcriptome analysis, iii) inflammatory cytokines and chemokines levels.
Read the detailed description
Coronaviruses (CoV) cause enteric and respiratory diseases. Most human CoVs, such as hCoV - 229E, OC43, NL63 and HKU1, cause mild respiratory disease, but the global spread of two previously well-knownCoVs: Severe Acute Respiratory Syndrome (SARS-CoV) and Middle East respiratory syndrome (MERS-CoV) has proven the lethal potential of human CoV.
While MERS-CoV is still not eliminated from the world, another highly pathogenic CoV, currently named SARS- CoV-2, started in December 2019 in Wuhan, in China. This new CoV caused a Chinese outbreak of severe pneumonia (coronavirus 2019 [COVID - 19]), and quickly spread to other countries.
Genomic analyzes show that SARS-CoV-2 shares a highly homological sequence with other beta-coronavirus (βCoV) as MERS-CoV and SARS-CoV.
Some work published in the 2000s has shown the presence of SARS-CoV viruses in neurons. Similarly, some experimental work has demonstrate that the MERS-COV5 and SARS-CoV6 viruses detected in the intra-nasal airways have an affinity for several brain regions such as brainstem or thalami. MERS-Cov viral particles have been found in several organs, including brain after injection of an inoculum in mice.
Several studies indicate that the brain region involved in this context is the brainstem.
The path taken by the virus is not yet clear, but several arguments in the literature indicate the hematogenous or lymphatic pathway, in particular during the acute phase of the infection. In addition, a viral invasion of the peripheral nerves could occur, followed by a secondary cerebral invasion with synaptic transmission already shown for other viruses. Epidemiological data for SARS-CoV-2 (COVID-19 infection) showing median time between first symptoms and dyspnea of 5 days, and hospitalization of 7 days10. This delayed period seems sufficient to allow the virus to invade the central nervous system. A recent work shows that patients infected with COVID-19 have neurological symptoms (headache, nausea, vomiting).
Large doses of sedation could be required to control a phase of severe delirium found in Covid-19 positive patients during the recovering phase in ICU. This delirium could be explained by the manifestation of septic encephalopathy, or even direct spread of the virus in the central nervous system. Study of neuroinflammation biomarkers in bleed could understand the progression of the disease and propose therapeutic strategies according to the patient phenotype. In this context, the idea of finding a neuroprotective treatment to limit the toxic effect of this virus on the brain is promising.
Dexmedetomidine is a selective adrenergic receptor agonist with antihypertensive, hypnotic and analgesic properties. This molecule has an important capacity of diffusion in the central nervous system with a central action in the locus cœruleus involved in vigilance thus explaining its sedative action; it also acts on the posterior grey column also providing analgesia via hyperpolarization of nerve fibers type C. Its distribution and its elimination are done according to a bicompartmental model. It is strongly linked to plasma proteins (94%) and is metabolized by the liver by glucuronidation, with an elimination half-life of two hours, 90% eliminated by the kidney and 10% in the stool. Dexmedetomidine is a powerful sympatholytic and should never be administered as a bolus or as a loading dose, it should be administered as a continuous infusion at a start dose of 0.7 µg / kg / min and then adjusted to sedation scores between 0,4 and 1,1 µg/kg/h.
Dexmedetomidine has neuroprotective effects. In experimental models such as the intraperitoneal injection of LPS, spinal cord lesions and ischemia-reperfusion, dexmedetomidine lower the cerebral inflammation directly on the microglial phenotype. The molecular pathway involved is not clear yet, however several studies show an action of Dexmedetomidine on the MAP kinase pathway.
Dexmedetomidine could be a direct neuroprotective agent by decreasing the brain inflammation induced by Covid-19 infection. Adapted utilisation of Dexmedetomidine for each patient profile could facilitate recovery and shorten the stay of patients in intensive care.
- Conditions
- SARS-CoV 2
- Being tested
- Inflammatory cytokines and chemokines profiles of patients with dexmedetomidine administration
- Keywords
- SARS-CoV-2, Covid-19, Dexmedetomidine, Neuroinflammation
- Medical subject headings
- COVID-19, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inflammatory cytokines and chemokines profiles of patients with dexmedetomidine administrationOther
Assigned Interventions:
- Blood samples collection at inclusion (D0) and follow-up visits (D2, D7 and M6)
- CAM-ICU scores during ICU hospitalisation, neurological questionnaires at M6 (GOAT, GOSE, MOCA, Barthel Index, PTSD, GDS, Rankin score, HADS)
| Study group | Role | What they receive |
|---|---|---|
| SARS-CoV-2 (Covid-19 positive) | Other | Patients hospitalized in intensive care unit (ICU), infected with SARS-CoV-2 Receives: Other: Inflammatory cytokines and chemokines profiles of patients with dexmedetomidine administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of inflammatory cytokines concentration (mmol / L) in Covid19 + patients from Baseline at 6 months
Measured: Month6
Secondary outcomes (4)
Change of interrelationship between inflammation (cytokines levels) and ICU delirium in Covid19 + patient from Baseline at 6 months
Measured: Month6
Modification in inflammatory genes expressed (expressed / non expressed) in PBMC between Baseline and M6
Measured: Month6
Change in quantity of chromatine's openings (chromatin accessibility profiles) in ICU patient recovering from covid19 infection
Measured: Day2, Month6
Change in genes expression in Covid-19 patient with delirium in ICU between Day2 and Month6
Measured: Day2, Month6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start24 Apr 2020
- Primary completion24 Oct 2022 (estimated)
- Study completion24 Oct 2022 (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.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- open-label monocentric cohort study, with intervention added
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent DEGOS, Pr, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413864
- Sponsor's protocol ID
- APHP200413
- Other IDs
- 2020-A00799-30
- Acronym
- DEXDO-COVID
- Status last verified
- May 2021
- First submitted
- 21 Apr 2020
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunomodulatory Profile of Dexmedetomidine Sedation in Patients Recovering After ARDS Covid-19
- ClinicalTrials.gov ID
- NCT04413864
- Acronym / sponsor ID
- DEXDO-COVID / APHP200413
- Conditions
- SARS-CoV 2
- Keywords
- SARS-CoV-2, Covid-19, Dexmedetomidine, Neuroinflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 24 Apr 2020 (actual)
- Primary completion
- 24 Oct 2022 (estimated)
- Study completion
- 24 Oct 2022 (estimated)
- First posted
- 4 Jun 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.
Covid-19 infection is due to SARS-CoV-2 member of the Coronavirus family represented by SARS- and MERS-CoVwith neuronal tropism capacity for the brainstem and thalami. Dexmedetomidine has(i) central antihypertensive (ii) sedative and (iii) neuroprotective properties and is often used during patient recovering after mechanical ventilation withdrawal.
Dexmedetomidine administration could change the immunomodulatory profile of Covid-19 patients and reduce inflammatory response.CAM-ICU scores and Blood samples from Covid-19 ICU patients will be collected at 4 different timepoints (before Dexmedetomidine administration, at D2, D7 and M6) to analyse the inflammatory profile with different approaches:i) chromatin accessibility, ii) transcriptome analysis, iii) inflammatory cytokines and chemokines levels.
Detailed description
Coronaviruses (CoV) cause enteric and respiratory diseases. Most human CoVs, such as hCoV - 229E, OC43, NL63 and HKU1, cause mild respiratory disease, but the global spread of two previously well-knownCoVs: Severe Acute Respiratory Syndrome (SARS-CoV) and Middle East respiratory syndrome (MERS-CoV) has proven the lethal potential of human CoV.
While MERS-CoV is still not eliminated from the world, another highly pathogenic CoV, currently named SARS- CoV-2, started in December 2019 in Wuhan, in China. This new CoV caused a Chinese outbreak of severe pneumonia (coronavirus 2019 [COVID - 19]), and quickly spread to other countries.
Genomic analyzes show that SARS-CoV-2 shares a highly homological sequence with other beta-coronavirus (βCoV) as MERS-CoV and SARS-CoV.
Some work published in the 2000s has shown the presence of SARS-CoV viruses in neurons. Similarly, some experimental work has demonstrate that the MERS-COV5 and SARS-CoV6 viruses detected in the intra-nasal airways have an affinity for several brain regions such as brainstem or thalami. MERS-Cov viral particles have been found in several organs, including brain after injection of an inoculum in mice.
Several studies indicate that the brain region involved in this context is the brainstem.
The path taken by the virus is not yet clear, but several arguments in the literature indicate the hematogenous or lymphatic pathway, in particular during the acute phase of the infection. In addition, a viral invasion of the peripheral nerves could occur, followed by a secondary cerebral invasion with synaptic transmission already shown for other viruses. Epidemiological data for SARS-CoV-2 (COVID-19 infection) showing median time between first symptoms and dyspnea of 5 days, and hospitalization of 7 days10. This delayed period seems sufficient to allow the virus to invade the central nervous system. A recent work shows that patients infected with COVID-19 have neurological symptoms (headache, nausea, vomiting).
Large doses of sedation could be required to control a phase of severe delirium found in Covid-19 positive patients during the recovering phase in ICU. This delirium could be explained by the manifestation of septic encephalopathy, or even direct spread of the virus in the central nervous system. Study of neuroinflammation biomarkers in bleed could understand the progression of the disease and propose therapeutic strategies according to the patient phenotype. In this context, the idea of finding a neuroprotective treatment to limit the toxic effect of this virus on the brain is promising.
Dexmedetomidine is a selective adrenergic receptor agonist with antihypertensive, hypnotic and analgesic properties. This molecule has an important capacity of diffusion in the central nervous system with a central action in the locus cœruleus involved in vigilance thus explaining its sedative action; it also acts on the posterior grey column also providing analgesia via hyperpolarization of nerve fibers type C. Its distribution and its elimination are done according to a bicompartmental model. It is strongly linked to plasma proteins (94%) and is metabolized by the liver by glucuronidation, with an elimination half-life of two hours, 90% eliminated by the kidney and 10% in the stool. Dexmedetomidine is a powerful sympatholytic and should never be administered as a bolus or as a loading dose, it should be administered as a continuous infusion at a start dose of 0.7 µg / kg / min and then adjusted to sedation scores between 0,4 and 1,1 µg/kg/h.
Dexmedetomidine has neuroprotective effects. In experimental models such as the intraperitoneal injection of LPS, spinal cord lesions and ischemia-reperfusion, dexmedetomidine lower the cerebral inflammation directly on the microglial phenotype. The molecular pathway involved is not clear yet, however several studies show an action of Dexmedetomidine on the MAP kinase pathway.
Dexmedetomidine could be a direct neuroprotective agent by decreasing the brain inflammation induced by Covid-19 infection. Adapted utilisation of Dexmedetomidine for each patient profile could facilitate recovery and shorten the stay of patients in intensive care.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open-label monocentric cohort study, with intervention added
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV-2 (Covid-19 positive) | Other | Other: Inflammatory cytokines and chemokines profiles of patients with dexmedetomidine administrationPatients hospitalized in intensive care unit (ICU), infected with SARS-CoV-2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient ≥ 18 years at time of inclusion
- Hospitalized in intensive care unit (ICU)
- Administration of dexmedetomidine scheduled for 7 days
- Intubated/ventilated patient infected with SARS-CoV-2 (Covid-19 positive patient)
- Patient affiliated to a social security system (French State medical aid excluded)
Key exclusion criteria (3 listed)
- Protected major (under safeguardship, curatorship or guardianship)
- Pregnancy or breastfeeding
- Contra-indication to dexmedetomidine administration
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 |
|---|---|---|
| Inflammatory cytokines and chemokines profiles of patients with dexmedetomidine administrationAssigned Interventions: * Blood samples collection at inclusion (D0) and follow-up visits (D2, D7 and M6) * CAM-ICU scores during ICU hospitalisation, neurological questionnaires at M6 (GOAT, GOSE, MOCA, Barthel Index, PTSD, GDS, Rankin score, HADS) | Other | SARS-CoV-2 (Covid-19 positive) |
Primary outcome
Change of inflammatory cytokines concentration (mmol / L) in Covid19 + patients from Baseline at 6 months
Time frame: Month6
4 secondary outcomes
Change of interrelationship between inflammation (cytokines levels) and ICU delirium in Covid19 + patient from Baseline at 6 months
Time frame: Month6
Modification in inflammatory genes expressed (expressed / non expressed) in PBMC between Baseline and M6
Time frame: Month6
Change in quantity of chromatine's openings (chromatin accessibility profiles) in ICU patient recovering from covid19 infection
Time frame: Day2, Month6
Change in genes expression in Covid-19 patient with delirium in ICU between Day2 and Month6
Time frame: Day2, Month6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
- Individual participant dataSharing planned: Undecided
Related trials for SARS-CoV 2
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
Not yet recruiting
Effect of MxA Guidance on Antiviral Treatment in Respiratory Viral Infections
Respiratory Viral Infections, Influenza
Recruiting
Effectiveness of Transcranial Direct Current in Patients With Persistent COVID-19 With Headaches and Chronic Pain.
COVID-19, Long COVID
Active, not recruiting
Clinical Validation of the NowFuture Digital Flu / COVID Test in Anterior Nasal Samples for Over-the-Counter (OTC) Use in Australia
SARS CoV 2 Infection, Influenza A Virus Infection
RecruitingObservational study
Determinants of SARS (Severe Acute Respiratory Syndrome)-COV2 (COVID-19) Persistence After Convalescence
COVID-19, Corona Virus Infection
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.
Vincent DEGOS, Pr study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inflammatory cytokines and chemokines profiles of patients with dexmedetomidine administration in people with SARS-CoV 2, run by Assistance Publique - Hôpitaux de Paris 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 7 inclusion and 3 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 21 Jun 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 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.
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 Vincent DEGOS, Pr (142163761 ext. +33, vincent.degos@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of inflammatory cytokines concentration (mmol / L) in Covid19 + patients from Baseline at 6 months (time frame: Month6). 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 21 Jun 2021.