NCT04877509

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
229

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 7, 2021

Completed
Last Updated

May 7, 2021

Status Verified

March 1, 2021

Enrollment Period

9 months

First QC Date

March 4, 2021

Last Update Submit

May 5, 2021

Conditions

Keywords

Covid19MicronutrimentsElderly

Outcome Measures

Primary Outcomes (1)

  • Selenium, Zinc and Copper, Vitamin A, D and E plasma concentrations of 229 over 50 year's patients hospitalized suffering from COVID-19.

    Up to 3 months

Study Arms (1)

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

Interventions

Micronutrient assays on heparinized plasma.

Over 50 year's COVID-19 patients hospitalized at HCL from 1st March to 29th May 2020.

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chls Cbap

Pierre-Bénite, France

Location

Related Links

MeSH Terms

Conditions

COVID-19

Interventions

SeleniumZincCopperVitamin AFumigant 93

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsMineralsMetals, HeavyTransition ElementsMetalsRetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological Factors

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2021

First Posted

May 7, 2021

Study Start

March 1, 2020

Primary Completion

December 1, 2020

Study Completion

May 1, 2021

Last Updated

May 7, 2021

Record last verified: 2021-03

Locations