COVID-19 Prevalence in UNIVI Geriatric Institutions: Epidemiological Study of Immunological Status With Rapid Serological Tests

NCT04790994 | Unknown

• 1 other identifier: 2020-A01838-31
• Study Type: observational
• Target: 1,145
• Locations: 1 country
• Sites: 1

Brief Summary

To date, little information is available on the prevalence of Covid-19 and data are lacking on the proportion of patients, institutional residents and caregivers who have actually been exposed to SARS Cov-2. With the NG Biotech rapid serological test, an individual's immunological status (presence of IgM and IgG antibodies) can be determined in 15 minutes on a finger-prick blood sample. The proposed trial will be a noninterventional study of immunological status among the residents and caregivers of 26 nursing homes and 4 geriatric healthcare institutions belonging to the UNIVI Group who are representative of the institutional geriatric population in France. The NG Biotech rapid test will be carried out concomitantly with polymerase chain reaction (PCR) tests performed within the framework of a national screening campaign. Data on risk factors in staff members and on specific COVID 19 symptoms in residents will also be collected. The study will terminate for residents and caregivers whose tests are both negative (absence of infection and no exposure to the virus). For residents and caregivers who have at least one positive test, follow-up visits will be scheduled in order to study the serology time course and the occurrence of reinfection (follow-up questionnaire).

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• Among asymptomatic residents and caregivers in French nursing homes and geriatric healthcare institutions belonging to the UNIVI Group: prevalence of covid 19

  positive RT-PCR test and/or (for residents) clinical diagnosis recorded in the medical file

  three months

• Exposure to SARS Cov-2 Among asymptomatic residents and caregivers in French nursing homes and geriatric healthcare institutions belonging to the UNIVI Group

  positive NG Biotech rapid serological test

  three months

Secondary Outcomes (4)

• Recurrence of Covid-19 at 1, 3 and 6 months among residents and caregivers who had at least on positive test at inclusion (RT-PCR test or NB Biotech rapid serological test)

  Time Frame: one, three and six months after inclusion]

• Risk factors for Covid-19 infection in caregivers

  three months

• Covid-19 symptoms among residents

  three months

• Prevalence of Covid-19 at 3 months

  three months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

1145 residents and 1134 professionals in 26 nursing homes and 4 geriatric hospitals

You may qualify if:

• Residents of participating nursing home - who benefited from a rapid diagnostic orientation serological test for COVID-19 - having given their agreement
• All staff members (doctors, nurses, health executives, caregivers, physiotherapists, ASH, stretcher bearers, psychologists, dieteticians, administrative staff, secretaries, ...) - who benefited from a rapid diagnostic orientation serologic test for COVID-19 - having given their agreement

You may not qualify if:

• Refusal to participate

Sponsors & Collaborators

• Centre Médical Porte Verte: lead

Study Sites (1)

CentreMédicalPorteVerte

Versailles, 78000, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

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

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: March 10, 2021
• Study Start: July 24, 2020
• Primary Completion: October 16, 2020
• Study Completion: April 16, 2021
• Last Updated: March 10, 2021

Record last verified: 2021-02

Locations

FR (1)