CoronavirusCOVIT-EHPADNCT04435119
Covid-19 and Vitamin D in Nursing-home
An observational study of Coronavirus, run by University Hospital, Angers at 1 site in France.
Trial summary
First epidemiological data about COVID-19 pandemic confirm that older adults are likely to experience severe and lethal forms of SARS-CoV-2 infection, in particular frail elderly living in nursing-homes. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Coronavirus
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2020to 15 May 2020
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: All residents in the nursing-home of Saint Laurent-de-Chamousset, France, during the COVID-19 epidemic (March-April 2020) This residents are suspected or diagnosed with COVID-19 (RT-PCR, chest CT scan)
Who may be able to join
- Living in the nursing-home of Saint Laurent-de-Chamousset, France, during the COVID-19 epidemic (March-April 2020)
- Being suspected or diagnosed with COVID-19 (RT-PCR, chest CT scan)
Who cannot join
- Opposition of the resident and/or relatives to the use of anonymized clinical-biological data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COvid-19 et VITamine d en EHPAD
First epidemiological data about COVID-19 pandemic confirm that older adults are likely to experience severe and lethal forms of SARS-CoV-2 infection, in particular frail elderly living in nursing-homes. Vitamin D could be a biological determinant of COVID-19, as indicated by genomic-guided tracing of SARS-CoV-2 targets in human cells. Epidemiological observational data are necessary for better understanding the links between vitamin D supplementation and COVID-19 outcomes, in particular in nursing-homes (in which the risk of hypovitaminosis D is very high).
The investigators had the opportunity to use information collected in a French middle-sized nursing-home affected by COVID-19 in March-April 2020, to determine whether recent vitamin D3 supplementation was associated with the prognosis of COVID-19 in residents infected with SARS-CoV-2. As recommended in French nursing-homes, all residents are systematically and regularly supplemented with bolus vitamin D3 (every single, 2 or 3 months, depending on residents).
Read more
The main objective of this study is to determine whether bolus vitamin D3 supplementation taken during or in the month before COVID-19 was effective in improving survival among frail elderly nursing-home residents infected with COVID-19 compared to those having received supplementation longer ago.
The secondary objective is to determine whether bolus vitamin D3 supplementation taken during or in the month before COVID-19 was effective in limiting the clinical severity of the infection according to the World Health Organization's Ordinal Scale for Clinical Improvement (OSCI) for COVID-19 compared to those having received supplementation longer ago.
Read the detailed description
Retrospective observational unicentric study in nursing-home residents with COVID-19. Health status monitoring data available until May 15, 2020. For all participants, gender, age, disability, history and comorbidities, treatments, date of last vitamin D3 supplementation, results of last blood test, date of suspicion / diagnosis of COVID-19, COVID-19 OSCI score, and eventual hospitalization or death (surveillance data available until May 15, 2020) are collected.
- Conditions
- Coronavirus
- Medical subject headings
- Coronavirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of deaths of any cause in nursing-home residents with SARS-CoV-2 infection, depending on the use of bolus vitamin D3 supplementation during or just before COVID-19
Measured: From March 2020 to 15 May 2020
Secondary outcomes (1)
Clinical severity score of COVID19 in nursing-home residents with SARS-CoV-2 infection, depending on the use of bolus vitamin D3 supplementation during or just before COVID-19
Clinical severity score of COVID19 is assessed with Ordinal Scale for Clinical Improvement (OSCI). OSCI ranges from 0 to 8, higher score meaning poorer outcome.
Measured: From March 2020 to 15 May 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start15 Mar 2020
- Primary completion15 May 2020
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoronavirusStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Retrospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Cédric ANNWEILER, MD, PhD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04435119
- Sponsor's protocol ID
- 2020/67
- Acronym
- COVIT-EHPAD
- Status last verified
- Jun 2020
- First submitted
- 12 Jun 2020
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COvid-19 et VITamine d en EHPAD
- ClinicalTrials.gov ID
- NCT04435119
- Acronym / sponsor ID
- COVIT-EHPAD / 2020/67
- Conditions
- Coronavirus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 17 Jun 2020 (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.
First epidemiological data about COVID-19 pandemic confirm that older adults are likely to experience severe and lethal forms of SARS-CoV-2 infection, in particular frail elderly living in nursing-homes. Vitamin D could be a biological determinant of COVID-19, as indicated by genomic-guided tracing of SARS-CoV-2 targets in human cells. Epidemiological observational data are necessary for better understanding the links between vitamin D supplementation and COVID-19 outcomes, in particular in nursing-homes (in which the risk of hypovitaminosis D is very high).
The investigators had the opportunity to use information collected in a French middle-sized nursing-home affected by COVID-19 in March-April 2020, to determine whether recent vitamin D3 supplementation was associated with the prognosis of COVID-19 in residents infected with SARS-CoV-2. As recommended in French nursing-homes, all residents are systematically and regularly supplemented with bolus vitamin D3 (every single, 2 or 3 months, depending on residents).
The main objective of this study is to determine whether bolus vitamin D3 supplementation taken during or in the month before COVID-19 was effective in improving survival among frail elderly nursing-home residents infected with COVID-19 compared to those having received supplementation longer ago.
The secondary objective is to determine whether bolus vitamin D3 supplementation taken during or in the month before COVID-19 was effective in limiting the clinical severity of the infection according to the World Health Organization's Ordinal Scale for Clinical Improvement (OSCI) for COVID-19 compared to those having received supplementation longer ago.
Detailed description
Retrospective observational unicentric study in nursing-home residents with COVID-19. Health status monitoring data available until May 15, 2020. For all participants, gender, age, disability, history and comorbidities, treatments, date of last vitamin D3 supplementation, results of last blood test, date of suspicion / diagnosis of COVID-19, COVID-19 OSCI score, and eventual hospitalization or death (surveillance data available until May 15, 2020) are collected.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All residents in the nursing-home of Saint Laurent-de-Chamousset, France, during the COVID-19 epidemic (March-April 2020) This residents are suspected or diagnosed with COVID-19 (RT-PCR, chest CT scan)
Key inclusion criteria (2 listed)
- Living in the nursing-home of Saint Laurent-de-Chamousset, France, during the COVID-19 epidemic (March-April 2020)
- Being suspected or diagnosed with COVID-19 (RT-PCR, chest CT scan)
Key exclusion criteria (1 listed)
- Opposition of the resident and/or relatives to the use of anonymized clinical-biological data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of deaths of any cause in nursing-home residents with SARS-CoV-2 infection, depending on the use of bolus vitamin D3 supplementation during or just before COVID-19
Time frame: From March 2020 to 15 May 2020
1 secondary outcome
Clinical severity score of COVID19 in nursing-home residents with SARS-CoV-2 infection, depending on the use of bolus vitamin D3 supplementation during or just before COVID-19
Time frame: From March 2020 to 15 May 2020
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 17 Jun 2020.
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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.
Cédric ANNWEILER, MD, PhD principal investigator
University Hospital, Angers
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 Coronavirus, run by University Hospital, Angers 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 2 inclusion and 1 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 17 Jun 2020. 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?
Number of deaths of any cause in nursing-home residents with SARS-CoV-2 infection, depending on the use of bolus vitamin D3 supplementation during or just before COVID-19 (time frame: From March 2020 to 15 May 2020). 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 17 Jun 2020.