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Micronutrient Status Involved in Immunity in Elderly Patients With COVID-19 (MicroCovAging)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04877509
Recruitment Status : Completed
First Posted : May 7, 2021
Last Update Posted : May 7, 2021
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

During the ongoing COVID-19 pandemic, age was clearly the major factor of mortality. Increasing age was strongly associated with this risk, with the upper 80 years age group having more than 12-fold increased risk compared with those aged 50-59 years. Male gender was also associated with a doubling of risk.

The elderly subject is particularly exposed to global denutrition with risk of micronutrients deficiencies such as vitamins and trace elements. Those deficits expose to lower immunity. In addition, viral infection as COVID-19 can also worsen these deficits.

In general, low levels or intakes of micronutrients such as Zn, Se and vitamin A have been associated with adverse clinical outcomes during viral infections. This notion has been confirmed in a recent review proposing that besides vitamins A and D also B vitamins, vitamin C, omega-3 polyunsaturated fatty acids, as well as selenium, zinc and iron should be considered in the assessment of micronutrients in COVID-19 patients.

In this context, the MicroCovAging study will evaluate copper, zinc and selenium, vitamin A, D and E status in elderly subjects affected by COVID- 19 and to correlate this status with prognosis of this disease.


Condition or disease Intervention/treatment
Covid19 Biological: Selenium, Zinc and Copper, Vitamin A, D, E plasma concentrations during patient hospitalization

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Study Type : Observational
Actual Enrollment : 229 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Micronutrient Status Involved in Immunity in Elderly Patients With COVID-19
Actual Study Start Date : March 1, 2020
Actual Primary Completion Date : December 1, 2020
Actual Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Over 50 year's COVID-19 patients hospitalized at HCL from 1st March to 29th May 2020. Biological: Selenium, Zinc and Copper, Vitamin A, D, E plasma concentrations during patient hospitalization
Micronutrient assays on heparinized plasma.




Primary Outcome Measures :
  1. Selenium, Zinc and Copper, Vitamin A, D and E plasma concentrations of 229 over 50 year's patients hospitalized suffering from COVID-19. [ Time Frame: Up to 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This is an observational study based on a monocentric historical cohort of ≥ 50 years patients hospitalized at HCL from 1st March 2020 to 30th May 2020and suffering from COVID-19.
Criteria

Inclusion Criteria:

  • Hospitalized adult patient ≥ 50 years at the time of admission,
  • Suffering from confirmed COVID-19 (positive quantitative PCR for SARS-CoV-2 and/or chest scanner suggestive of COVID-19),
  • Informed and non-opposed to the research. Patient will be informed of the study by his medical doctor during hospitalization or by post thanks to a generic information sheet dedicated to COVID-19 researches.

Exclusion Criteria:

  • Adult patient < 50 years at the time of admission
  • Negative quantitative PCR for SARS-Cov-2

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04877509


Locations
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France
Chls Cbap
Pierre-Bénite, France
Sponsors and Collaborators
Hospices Civils de Lyon
Additional Information:
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04877509    
Other Study ID Numbers: 69HCL20_0730 A067
First Posted: May 7, 2021    Key Record Dates
Last Update Posted: May 7, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Covid19
Micronutriments
Elderly
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vitamin D
Vitamin A
Selenium
Copper
Vitamins
Micronutrients
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Trace Elements
Bone Density Conservation Agents