Covid19MicroCovAgingNCT04877509
Micronutrient Status Involved in Immunity in Elderly Patients With COVID-19
An observational study of Covid19, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Selenium, Zinc and Copper, Vitamin A, D, E plasma concentrations during patient hospitalization
- How many people
- 229 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2020to 1 May 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Adult patient < 50 years at the time of admission
- Negative quantitative PCR for SARS-Cov-2
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Covid19
- Being tested
- Selenium, Zinc and Copper, Vitamin A, D, E plasma concentrations during patient hospitalization
- Keywords
- Covid19, Micronutriments, Elderly
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selenium, Zinc and Copper, Vitamin A, D, E plasma concentrations during patient hospitalizationBiological
Micronutrient assays on heparinized plasma.
| Study group | Role | What they receive |
|---|---|---|
| Over 50 year's COVID-19 patients hospitalized at HCL from 1st March to 29th May 2020. | Not described Receives: Biological: Selenium, Zinc and Copper, Vitamin A, D, E plasma concentrations during patient hospitalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Selenium, Zinc and Copper, Vitamin A, D and E plasma concentrations of 229 over 50 year's patients hospitalized suffering from COVID-19.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start1 Mar 2020
- Primary completion1 Dec 2020
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Other
- Enrolment
- 229 participants (actual)
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
- NCT04877509
- Sponsor's protocol ID
- 69HCL20_0730 A067
- Acronym
- MicroCovAging
- Status last verified
- Mar 2021
- First submitted
- 4 Mar 2021
- Last updated
- 7 May 2021
- 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 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micronutrient Status Involved in Immunity in Elderly Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04877509
- Acronym / sponsor ID
- MicroCovAging / 69HCL20_0730 A067
- Conditions
- Covid19
- Keywords
- Covid19, Micronutriments, Elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 7 May 2021 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Adult patient < 50 years at the time of admission
- Negative quantitative PCR for SARS-Cov-2
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 |
|---|---|---|
| Selenium, Zinc and Copper, Vitamin A, D, E plasma concentrations during patient hospitalizationMicronutrient assays on heparinized plasma. | Biological | Over 50 year's COVID-19 patients hospitalized at HCL from 1st March to 29th May 2020. |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Related InfoLink provided by the sponsor.
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Hospices Civils de Lyon at 1 site 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 7 May 2021.