Coronavirus Clinical Trial
— COVIT-EHPADOfficial title:
COvid-19 et VITamine d en EHPAD
NCT number | NCT04435119 |
Other study ID # | 2020/67 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 15, 2020 |
Est. completion date | May 15, 2020 |
Verified date | June 2020 |
Source | University Hospital, Angers |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 96 |
Est. completion date | May 15, 2020 |
Est. primary completion date | May 15, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 70 Years and older |
Eligibility |
Inclusion Criteria: - 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) Exclusion Criteria: - Opposition of the resident and/or relatives to the use of anonymized clinical-biological data |
Country | Name | City | State |
---|---|---|---|
France | Angers University Hospital | Angers |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Angers |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | From March 2020 to 15 May 2020 | ||
Secondary | 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. | From March 2020 to 15 May 2020 |
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