Covid19NCT06468761
2-year Mortality After COVID-19 in Nursing Home Residents
An observational study of Covid19, run by Bichat Hospital at 1 site in France.
Trial summary
This was a retrospective study conducted in three Nursing Homes (NHs). Residents who had survived the 1st CoPW (March to May 2020) were included. The diagnosis of COVID-19 was based on the results of a positive reverse transcriptase-polymerase chain reaction test. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Covid19
- How many people
- 315 participants
- Where
- 1 siteFrance
- Study dates
- 11 May 2020to 26 Jul 2022
- 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: 315 residents of 3 nursibg omes, mean age 86 years old. 50% severe disability. 111 contracted COVID-19 and survived the first pandemic wave.
Who may be able to join
- Living in one of the Nursing Homes during the fiorst COVID-19 pandemic wave
- Having survived the first pandemic wave
Who cannot join
- Residents who died during the first pandemic wave
- Refusal for articipation to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COVID-19 Infection and 2-year Mortality in Nursing Home Residents Who Survived the First Wave of the Pandemic
This was a retrospective study conducted in three Nursing Homes (NHs). Residents who had survived the 1st CoPW (March to May 2020) were included. The diagnosis of COVID-19 was based on the results of a positive reverse transcriptase-polymerase chain reaction test. The collected data also included age, sex, length of residence in the NH, disability status, legal guardianship status, nutritional status, need for texture-modified food, hospitalization or Emergency Department visits during lockdown and SARS-COV2 vaccination status during the follow-up. Non-adjusted and adjusted Cox models were used to analyse factors associated with 2-year post-1stCoPW mortality.
- Conditions
- Covid19
- Keywords
- COVID-19, Older Adults, Nursing home, Long-tem mortality
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Measured: months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start11 May 2020
- Primary completion25 Jul 2022
- Study completion26 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- 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
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bichat Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Sanchez, Bichat Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06468761
- Sponsor's protocol ID
- 22021
- Status last verified
- Jun 2024
- First submitted
- 18 Jun 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Infection and 2-year Mortality in Nursing Home Residents Who Survived the First Wave of the Pandemic
- ClinicalTrials.gov ID
- NCT06468761
- Acronym / sponsor ID
- 22021
- Conditions
- Covid19
- Keywords
- COVID-19, Older Adults, Nursing home, Long-tem mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Bichat HospitalUniversity, hospital or other
- Study start
- 11 May 2020 (actual)
- Primary completion
- 25 Jul 2022 (actual)
- Study completion
- 26 Jul 2022 (actual)
- First posted
- 21 Jun 2024 (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.
This was a retrospective study conducted in three Nursing Homes (NHs). Residents who had survived the 1st CoPW (March to May 2020) were included. The diagnosis of COVID-19 was based on the results of a positive reverse transcriptase-polymerase chain reaction test. The collected data also included age, sex, length of residence in the NH, disability status, legal guardianship status, nutritional status, need for texture-modified food, hospitalization or Emergency Department visits during lockdown and SARS-COV2 vaccination status during the follow-up. Non-adjusted and adjusted Cox models were used to analyse factors associated with 2-year post-1stCoPW mortality.
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
- 315 residents of 3 nursibg omes, mean age 86 years old. 50% severe disability. 111 contracted COVID-19 and survived the first pandemic wave.
Key inclusion criteria (2 listed)
- Living in one of the Nursing Homes during the fiorst COVID-19 pandemic wave
- Having survived the first pandemic wave
Key exclusion criteria (2 listed)
- Residents who died during the first pandemic wave
- Refusal for articipation to the study
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
All cause mortality
Time frame: months
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 21 Jun 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Covid19, run by Bichat Hospital 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 2 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 21 Jun 2024. 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?
All cause mortality (time frame: months). 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 21 Jun 2024.