Patients Hospitalized in the Hospices Civils of LyonCODYSNCT04522037
Measurement of the Efficacy of MORPHINE in the Early Management of Dyspnea in COVID-19 Positive Patients
An observational study of Patients Hospitalized in the Hospices Civils of Lyon and COVID-19 Disease, run by Hospices Civils de Lyon at 3 sites in France.
Trial summary
Morphine is used in the treatment of dyspnea and polypnea with a proven benefit on the improvement of these symptoms, both etiologically and symptomatically. This medication is used in particular in palliative care for this type of symptom. The Sars CoV2 viral pneumonia table can lead to respiratory distress. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Hospitalized in the Hospices Civils of Lyon, COVID-19 Disease, Moderate to Severe Dyspnea
- How many people
- 200 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Jun 2020to Feb 2021
- Phase
- Observational
- 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
Study population: patients hospitalized at the hospices civils of Lyon with a level of care 3 or 4 receiving morphinic and not receiving morphinic treatment for COVID-19 disease dyspnea.
Who may be able to join
- Age over 18 years.
- Having had a Covid-19 respiratory disease confirmed by PCR or TDM or anamnestic criterion for patients living in communities for the elderly (respiratory symptomatology suggestive and at least 3 cases confirmed in the living environment).
- Having had respiratory severity criteria: respiratory distress syndrome including FR> 25 / min and oxygen-demand> 4 L / min to maintain a SpO2> 90% at inclusion.
- Having had a defined level of care after collegial discussion notified in the file rejecting the external cardiac massage and admission to the intensive care unit (Level 3 and 4 on the protocols of the Hospices Civils de Lyon).
- Collection of non-opposition
Who cannot join
- -
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
Hôpital de la Croix Rousse / GHN
Lyon, 69004
Myriam Legenne, Dr, 4 72 07 25 79 ext. +33, myriam.legenne@chu-lyon.fr
- Recruiting
Hôpital Edouard Herriot
Lyon, 69008
Sophie Francioni, Dr, 4 72 11 96 08 ext. +33, sophie.francioni@chu-lyon.fr
- Recruiting
Hôpital Lyon Sud
Pierre-Bénite, 69445
Guillaume Economos, Dr, 4 78 86 41 48 ext. +33, guillaume.economos@chu-lyon.fr
About this study
Official title: Retrospective Study of the Measurement of the Efficacy of MORPHINE in the Early Management of Dyspnea in COVID-19 Positive Patients With Moderate to Severe Impairment Without Objective of Resuscitation Management (Level of Care 3 and 4) at the Hospices Civils of Lyon
Morphine is used in the treatment of dyspnea and polypnea with a proven benefit on the improvement of these symptoms, both etiologically and symptomatically. This medication is used in particular in palliative care for this type of symptom.
The Sars CoV2 viral pneumonia table can lead to respiratory distress. In patients with moderate to severe impairment without goal of resuscitation (level of care 3 and 4), the introduction of morphine may sometimes be necessary to relieve respiratory symptoms. These also lead to major exhaustion which can worsen the clinical picture. However, the prescription of morphine is not systematic in front of a respiratory distress table.
Read more
The investigators hypothesized that early treatment with morphine lead to a better management of dyspnea, quality of live and survival in COVID-19 positive participants patients when there is not resuscitation objective management (level of care 3 and 4).
The objective is to measure the efficacy of morphine in the early management of dyspnea, quality of life and survival in COVID-19 positive participants patients treated in the Hospices Civils of Lyon during COVID-19 pandemic.
- Conditions
- Patients Hospitalized in the Hospices Civils of Lyon, COVID-19 Disease, Moderate to Severe Dyspnea, Without Resuscitation Objective Management
- Being tested
- No intervention / Compare the difference in respiratory rate between H0 and H12 of the initiation of morphine between the control and interventional groups
- Keywords
- COVID-19 disease, level of care 3 and 4, morphinic treatment, dyspnea
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention / Compare the difference in respiratory rate between H0 and H12 of the initiation of morphine between the control and interventional groupsOther
Respiratory rate is analyzed with the scope (approved by the French national medical authorities)
| Study group | Role | What they receive |
|---|---|---|
| interventional group | patients hospitalized at the hospices civils of Lyon with a level of care 3 or 4 receiving morphinic treatment for COVID-19 disease dyspnea. Receives: Other: No intervention / Compare the difference in respiratory rate between H0 and H12 of the initiation of morphine between the control and interventional groups | |
| control group | patients hospitalized at the hospices civils of Lyon with a level of care 3 or 4 not receiving morphinic treatment for COVID-19 disease dyspnea. Receives: Other: No intervention / Compare the difference in respiratory rate between H0 and H12 of the initiation of morphine between the control and interventional groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Title : Reduction of respiratory rate between Hour 0 and Hour 12 at initiation of morphine treatment
The respiratory rate is analyzed at Hour 0 and Hour 12 by a scope.
Measured: Hour 0 and Hour 12 after initiation of morphinic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start1 Jun 2020
- Primary completionSep 2020 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Hospitalized in the Hospices Civils of LyonStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522037
- Sponsor's protocol ID
- CODYS_2020
- Acronym
- CODYS
- Status last verified
- Jul 2020
- First submitted
- 6 Jul 2020
- Last updated
- 21 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of the Measurement of the Efficacy of MORPHINE in the Early Management of Dyspnea in COVID-19 Positive Patients With Moderate to Severe Impairment Without Objective of Resuscitation Management (Level of Care 3 and 4) at the Hospices Civils of Lyon
- ClinicalTrials.gov ID
- NCT04522037
- Acronym / sponsor ID
- CODYS / CODYS_2020
- Conditions
- Patients Hospitalized in the Hospices Civils of Lyon, COVID-19 Disease, Moderate to Severe Dyspnea, Without Resuscitation Objective Management
- Keywords
- COVID-19 disease, level of care 3 and 4, morphinic treatment, dyspnea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 21 Aug 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.
Morphine is used in the treatment of dyspnea and polypnea with a proven benefit on the improvement of these symptoms, both etiologically and symptomatically. This medication is used in particular in palliative care for this type of symptom.
The Sars CoV2 viral pneumonia table can lead to respiratory distress. In patients with moderate to severe impairment without goal of resuscitation (level of care 3 and 4), the introduction of morphine may sometimes be necessary to relieve respiratory symptoms. These also lead to major exhaustion which can worsen the clinical picture. However, the prescription of morphine is not systematic in front of a respiratory distress table.
The investigators hypothesized that early treatment with morphine lead to a better management of dyspnea, quality of live and survival in COVID-19 positive participants patients when there is not resuscitation objective management (level of care 3 and 4).
The objective is to measure the efficacy of morphine in the early management of dyspnea, quality of life and survival in COVID-19 positive participants patients treated in the Hospices Civils of Lyon during COVID-19 pandemic.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interventional group | – | Other: No intervention / Compare the difference in respiratory rate between H0 and H12 of the initiation of morphine between the control and interventional groupspatients hospitalized at the hospices civils of Lyon with a level of care 3 or 4 receiving morphinic treatment for COVID-19 disease dyspnea. |
| control group | – | Other: No intervention / Compare the difference in respiratory rate between H0 and H12 of the initiation of morphine between the control and interventional groupspatients hospitalized at the hospices civils of Lyon with a level of care 3 or 4 not receiving morphinic treatment for COVID-19 disease dyspnea. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients hospitalized at the hospices civils of Lyon with a level of care 3 or 4 receiving morphinic and not receiving morphinic treatment for COVID-19 disease dyspnea.
Key inclusion criteria (5 listed)
- Age over 18 years.
- Having had a Covid-19 respiratory disease confirmed by PCR or TDM or anamnestic criterion for patients living in communities for the elderly (respiratory symptomatology suggestive and at least 3 cases confirmed in the living environment).
- Having had respiratory severity criteria: respiratory distress syndrome including FR> 25 / min and oxygen-demand> 4 L / min to maintain a SpO2> 90% at inclusion.
- Having had a defined level of care after collegial discussion notified in the file rejecting the external cardiac massage and admission to the intensive care unit (Level 3 and 4 on the protocols of the Hospices Civils de Lyon).
- Collection of non-opposition
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| No intervention / Compare the difference in respiratory rate between H0 and H12 of the initiation of morphine between the control and interventional groupsRespiratory rate is analyzed with the scope (approved by the French national medical authorities) | Other | control group, interventional group |
Primary outcome
Title : Reduction of respiratory rate between Hour 0 and Hour 12 at initiation of morphine treatment
Time frame: Hour 0 and Hour 12 after initiation of morphinic treatment
The respiratory rate is analyzed at Hour 0 and Hour 12 by a scope.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Hospitalized in the Hospices Civils of Lyon and COVID-19 Disease, run by Hospices Civils de Lyon at 3 sites 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 5 inclusion and 1 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 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Myriam Legenne (4 72 07 25 79 ext. +33, myriam.legenne@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Title : Reduction of respiratory rate between Hour 0 and Hour 12 at initiation of morphine treatment (time frame: Hour 0 and Hour 12 after initiation of morphinic treatment). 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 Aug 2020.