Covid19 Clinical Trial
— FRA-COVIDOfficial title:
Relationship Between Frailty and Clinical Outcomes in Elderly Patients With COVID-19
NCT number | NCT04412265 |
Other study ID # | FRA-COVID |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 16, 2020 |
Est. completion date | December 15, 2021 |
Verified date | April 2022 |
Source | University of Milano Bicocca |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is a multicentric retro-prospective observational study that wants to evaluate the relation between frailty and clinical outcomes in elderly patients with COVID-19.
Status | Completed |
Enrollment | 1344 |
Est. completion date | December 15, 2021 |
Est. primary completion date | June 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria - Diagnosis of COVID related pneumonia - Informed consent freely granted Exclusion criteria - Age less than 18 years |
Country | Name | City | State |
---|---|---|---|
Italy | Dipartimento di Geriatria, Fondazione Poliambulanza | Brescia | |
Italy | Dipartimento di Medicina e Riabilitazione, Istituto Clinico Ospedale S. Anna | Brescia | |
Italy | UO Malattie Infettive, Spedali Civili | Brescia | |
Italy | UOC Medicina I a indirizzo Geriatrico, Spedali Civili | Montichiari | |
Italy | ASST Monza-Ospedale San Gerardo | Monza | |
Italy | SCDU Geriatria, AOU Città della Salute e della Scienza - Presidio Molinette | Torino |
Lead Sponsor | Collaborator |
---|---|
University of Milano Bicocca |
Italy,
Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8. Review. Erratum in: Lancet. 2013 Oct 19;382(9901):1328. — View Citation
Johnstone J, Parsons R, Botelho F, Millar J, McNeil S, Fulop T, McElhaney J, Andrew MK, Walter SD, Devereaux PJ, Malekesmaeili M, Brinkman RR, Mahony J, Bramson J, Loeb M. Immune biomarkers predictive of respiratory viral infection in elderly nursing home residents. PLoS One. 2014 Oct 2;9(9):e108481. doi: 10.1371/journal.pone.0108481. eCollection 2014. — View Citation
Subbe CP, Kruger M, Rutherford P, Gemmel L. Validation of a modified Early Warning Score in medical admissions. QJM. 2001 Oct;94(10):521-6. — View Citation
Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994. Erratum in: JAMA Intern Med. 2020 Jul 1;180(7):1031. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Development of a tool to measure frailty | The aim of the project is to evaluate whether a tool built to measure frailty in elderly patients admitted to the COVID + hospital wards is more accurate in predicting clinical states than a clinical evaluation developed on age and comorbidity. | Until patient discharge from the hospital (approximately 1 year). | |
Secondary | A "proxy" variable of the fragility index can be built on the basis of regional administrative databases only. | Assess whether a "proxy" variable of the fragility index can be built on the basis of regional administrative databases only, which is able to predict the clinical outcomes of COVID + patients better than age and comorbidities alone. | Until patient discharge from the hospital (approximately 1 year). | |
Secondary | Give elements to focus the screening policies for COVID19. | Relate different levels of chronicity with the susceptibility of the elderly subject to infection to give elements to focus the screening policies for COVID19. | Until patient discharge from the hospital (approximately 1 year). | |
Secondary | Give the prevention of contagion at the elderly population level. | Relate different levels of chronicity with the susceptibility of the elderly subject to infection to prevent the contagion at the elderly population level. | Until patient discharge from the hospital (approximately 1 year). |
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