Coronavirus InfectionNCT04385212
Outcomes in Hospitalized Older Patients With COVID-19
An observational study of Coronavirus Infection and Sars-CoV2, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
In December 2019, the first patients infected with the 2019 novel coronavirus (2019-nCoV) were diagnosed in Wuhan. The clinical presentation and course of Severe Acute Respiratory Syndrome-CoV-2 (SARS-CoV-2) infection is poorly understood in older patients and is certainly different from the general population. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Coronavirus Infection, Sars-CoV2, Elderly Infection
- How many people
- 230 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Mar 2020to 14 Apr 2020
- 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 65 years and older
- All sexes
- Older adult
Study population: All the patients hospitalized in our geriatrics department with Sars-Cov-2 infection
Who may be able to join
- Diagnosis of COVID-19, defined by a positive polymerase chain reaction (PCR) test for SARS-CoV-2 detection, obtained by a nasopharyngeal swab or sputum sample.
- Or patients with negative virus detection in the PCR test, but with a high clinical suspicion will also be considered with COVID-19.
Who cannot join
- Presence of document indicating a refusal to participate in a research study.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Rehabilitation and Geriatrics
Geneva, 1256
About this study
Official title: COVIDAge Study- Hospital Des Trois-Chêne
In December 2019, the first patients infected with the 2019 novel coronavirus (2019-nCoV) were diagnosed in Wuhan. The clinical presentation and course of Severe Acute Respiratory Syndrome-CoV-2 (SARS-CoV-2) infection is poorly understood in older patients and is certainly different from the general population. This project is designed to better understand and to determine clinical, biological and radiological markers of poor adverse outcomes in hospitalized older patients diagnosed with COVID-19.
- Conditions
- Coronavirus Infection, Sars-CoV2, Elderly Infection, Old Age; Debility
- Medical subject headings
- Coronavirus Infections, Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the relative contributions of comorbidities on intra-hospitalized death
We measure functional score of comorbidities
Measured: 1 month
Secondary outcomes (2)
To evaluate the relative contributions of functional characteristics on intra-hospitalized death
We measure Functional Independence Measure scale
Measured: 1 month
To explore specific clinical profiles that may influence COVID-19 disease outcomes in the elderly based on geriatrics syndromes
We describe the role fo geriatric syndrome such as delirium, falls
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start13 Mar 2020
- Primary completion14 Apr 2020
- Study completion14 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- 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
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Serratrice, MD, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385212
- Sponsor's protocol ID
- 2020-00819
- Status last verified
- May 2020
- First submitted
- 29 Apr 2020
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVIDAge Study- Hospital Des Trois-Chêne
- ClinicalTrials.gov ID
- NCT04385212
- Acronym / sponsor ID
- 2020-00819
- Conditions
- Coronavirus Infection, Sars-CoV2, Elderly Infection, Old Age; Debility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 13 Mar 2020 (actual)
- Primary completion
- 14 Apr 2020 (actual)
- Study completion
- 14 Apr 2020 (actual)
- First posted
- 12 May 2020 (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.
In December 2019, the first patients infected with the 2019 novel coronavirus (2019-nCoV) were diagnosed in Wuhan. The clinical presentation and course of Severe Acute Respiratory Syndrome-CoV-2 (SARS-CoV-2) infection is poorly understood in older patients and is certainly different from the general population. This project is designed to better understand and to determine clinical, biological and radiological markers of poor adverse outcomes in hospitalized older patients diagnosed with COVID-19.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- All the patients hospitalized in our geriatrics department with Sars-Cov-2 infection
Key inclusion criteria (2 listed)
- Diagnosis of COVID-19, defined by a positive polymerase chain reaction (PCR) test for SARS-CoV-2 detection, obtained by a nasopharyngeal swab or sputum sample.
- Or patients with negative virus detection in the PCR test, but with a high clinical suspicion will also be considered with COVID-19.
Key exclusion criteria (1 listed)
- Presence of document indicating a refusal to participate in a research 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
To evaluate the relative contributions of comorbidities on intra-hospitalized death
Time frame: 1 month
We measure functional score of comorbidities
2 secondary outcomes
To evaluate the relative contributions of functional characteristics on intra-hospitalized death
Time frame: 1 month
To explore specific clinical profiles that may influence COVID-19 disease outcomes in the elderly based on geriatrics syndromes
Time frame: 1 month
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 12 May 2020.
- Individual participant dataSharing planned: Undecided
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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 Coronavirus Infection and Sars-CoV2, run by University Hospital, Geneva at 1 site in Switzerland.
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 1 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 12 May 2020. 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 Switzerland. 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?
To evaluate the relative contributions of comorbidities on intra-hospitalized death (time frame: 1 month). 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 12 May 2020.