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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04435223
Other study ID # NGUYEN AOIc 2020
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 7, 2020
Est. completion date May 7, 2020

Study information

Verified date June 2020
Source Centre Hospitalier Universitaire Dijon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

SARS-COV 2 infection might be responsible for sever pneumonia. Obesity seems to be a risk factor for severe SARS-COV 2 pneumonia. Lipid metabolism alteration are described with both obesity and sepsis. The aim of the present study was to describe association between lipid metabolism, obesity, sepsis inflammation and clinical outcome in COVID-19 patient with severe pneumonia compared with severe pneumonia caused by other pathogenes.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date May 7, 2020
Est. primary completion date May 7, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 2 of the following criteria: Cough/ Dyspnea/ Spitting/ Thoracic pain/ Hyperthermia (>=38 °C) Hypothermia (< 35°C) AND new radiologic pulmonary infiltrate

- At admission or within 48 hours following hospital admission

- With 2 qSOFA criteria: MAP =< 100 mmHg, Respiratory Rate >= 22, Glasgow score < 15 OR on mechanical ventilation OR under vasopressor

- Age > 18

- affiliated to social security

Exclusion Criteria:

- Pregnancy

- immunodepression

- Pathology known to cause severe lymphopenia

- hospitalisation within 3 month before inclusion AND sepsis

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
biological assays in particular on the lipid metabolism
bioassays carried out on samples already collected and conserved

Locations

Country Name City State
France Chu Dijon Bourgogne Dijon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cholesterol concentration Within 48 hours following hospital admission
Secondary LDL cholesterol / HDL cholesterol/ Lipoprotein size and composition/ Non esterified Fatty acid/ Triglyceridemia/ CETP and PLTP activity/ apolipoprotein canceration/ lipid peroxidation/ Pro and anti inflammatory profile. Ventilator free days (28 days) Within 48 hours following hospital admission
See also
  Status Clinical Trial Phase
Terminated NCT04369469 - Efficacy and Safety Study of IV Ravulizumab in Patients With COVID-19 Severe Pneumonia Phase 3