Measurement of the Efficacy of MORPHINE in the Early Management of Dyspnea in COVID-19 Positive Patients

COVID-19 Disease Clinical Trial

— CODYS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04522037
• Other study ID #: CODYS_2020
• Status: Recruiting
• Start date: June 1, 2020
• Est. completion date: February 2021

Study information

• Verified date: July 2020
• Source: Hospices Civils de Lyon
• Contact: Myriam Legenne
• Phone: 4 72 07 25 79
• Email: myriam.legenne[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 2021
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• COVID-19 Disease
• Dyspnea
• Moderate to Severe Dyspnea
• Patients Hospitalized in the Hospices Civils of Lyon
• Without Resuscitation Objective Management

Intervention

Other:
• No intervention / Compare the difference in respiratory rate between H0 and H12 of the initiation of morphine between the control and interventional groups
Respiratory rate is analyzed with the scope (approved by the French national medical authorities)

Locations

Country	Name	City	State
France	Hôpital de la Croix Rousse / GHN	Lyon
France	Hôpital Edouard Herriot	Lyon
France	Hôpital Lyon Sud	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Hour 0 and Hour 12 after initiation of morphinic treatment