Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT04790994 |
Other study ID # |
2020-A01838-31 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
July 24, 2020 |
Est. completion date |
April 16, 2021 |
Study information
Verified date |
February 2021 |
Source |
Centre Médical Porte Verte |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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).
Description:
Type of study: multicentric prospective observational Study location: 26 nursing homes and 4
geriatric hospitals belonging to the UNIVI Group in France
Context:
At the end of the Covid-19 containment period in France, data published by Public Health
France revealed that frail and dependent elderly people in nursing homes and geriatric
healthcare institutions had paid a heavy tribute. As of May 4, 2020, the majority of reported
Covid-19 cases (n=4,600; 63%) had occurred in nursing home residents and more than one-third
(n=2,664; 37%) in patients in geriatric healthcare institutions. A total of 71,216 Covid-19
cases of which 33,948 (48%) were confirmed by reverse transferase polymerase chain reaction
(RT-PCR) tests were reported to health authorities (Agence Régionale de Santé, ARS). Among
reported cases, there were 12,726 deaths. Three-quarters of these deaths (9,501; 75%)
occurred in geriatric institutions, the vast majority (99%) in nursing homes and 3,321 (25%)
in hospitals. Reports of infection among staff members of these institutions reached 39,294
cases, of which 18,175 (46%) were confirmed by RT- PCR.
The confinement allowed a significant and continuous decrease in the number of Covid cases in
French geriatric institutions since the beginning of April. The proportion of new cases
observed among institutionalized geriatric residents has since fallen sharply, particularly
in the most affected geographic regions. This is why deconfinement should be gradual and
should be constantly reassessed on the basis of national and regional epidemiological data.
Each nursing home should to take into account its own daily data showing the number of new
diagnoses or suspected cases among residents and caregivers, keeping in mind the risk of
transmission by visitors in the event of a recurrence of the epidemic.
In France, the deconfinement strategy began on April 20, 2020 in Île-de-France. Family visits
under strict conditions were authorized in geriatric institutions. Currently, the modus
operandi is accompanied by a PCR test campaign in order to have an inventory of the COVID
status of all institutional residents and caregivers. Thus, any resident with a positive PCR
test will be isolated until recovery and any caregiver with a positive PCR test will be
quarantined.
For nursing home admissions, in accordance with ARS guidelines, a PCR test may be requested
upon prescription from the institution's coordinating physician. Room confinement for newly
admitted residents will be determined by the institution's geographical localization.
Administrative districts are classified in two zones, red and green. For institutions in the
red zone, room confinement with close medical supervision is compulsory for 14 days,
corresponding to the viral incubation time. For institutions in the green zone, room
confinement is not mandatory, but close medical surveillance is recommended.
What could NG Biotech rapid serological tests bring to the deconfinement strategy? These
tests make it possible to determine an individual's immunological status (presence of IgM and
IgG antibodies) in 15 minutes on a finger-prick blood sample. The test cannot be used in the
acute phase of the disease, but makes it possible to confirm the serological status of an
asymptomatic patient 15 days after the first clinical signs. Test sensitivity (ability to
identify antibodies) is 100%. Serological testing does not answer the same question as PCR.
PCR directly detects the presence of the virus, optimal in the first 7 days, it can remain
positive for up to 3 weeks or even beyond. The serological test provides information on
whether or not there is contact with the virus. If the serological test is positive in an
asymptomatic patient, the patient is likely more than 15 days from symptom onset. It does not
provide information on the risk of contagiousness. For nursing homes and geriatric healthcare
institutions, use of serological testing, common law is applicable. The superior French
health agency (Haute Autorité de Santé, HAS) specifies that these tests are indicated for
epidemiological study or as a diagnostic catch-up tool (Place of rapid serotests in the
strategy for the management of the COVID-19, HAS, May 14, 2020). The HAS recommendation
specifies that rapid diagnostic tests must be performed by: - Professionals and staff who
have previously received training in the use of COVID-19 rapid diagnostic tests - Doctors
practicing in private practice - Doctors, medical biologists, midwives working in an
institution or in a healthcare service (e.g. specialized screening structures) - Nurses or
laboratory technicians working in an institution or in a healthcare service under the
supervision of a doctor or a medical biologist - Midwives or nurses working in a prevention
structure or an associative structure involved in health prevention - Community pharmacists -
Employees or volunteers, non-healthcare professionals working in a prevention structure or an
association structure, provided that they have previously received training in the use of
rapid diagnostic tests.
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. Likewise, in the scientific literature, there is uncertainty among
people who have acquired immunity as to the persistence of neutralizing antibodies at 6
months and the risk of re-infection with COVID 19 after a primary infection. A major campaign
of serological tests is in preparation in the geriatric institutions of the UNIVI Group. This
study is based on this campaign using data collected in 26 nursing homes and 4 geriatric
healthcare institutions. In total, around 2,000 residents, and 2,000 caregivers will be
tested. The residents and caregivers of the tested institutions are representative of the
institutionalized geriatric population in France. It is thus proposed to carry out a
non-interventional study among residents and caregivers in nursing homes and in healthcare
institutions belonging to the UNIVI Group. NG Biotech rapid tests will be performed
concomitantly with PCR tests made within the framework of the national screening campaign.