Covid19NCT06321367
Model to Predict Coinfection in Elderly Patients With COVID-19
An observational study of Covid19, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
The goal of this observational study is to learn about the clinical characteristics and construction of a predictive model in elderly COVID-19 patients. The main question it aims to answer is the main clinical characteristics and risk factors of elderly COVID-19 patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2022to 30 Jun 2023
- How long will I take part?
- 4 Weeks
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Elderly COVID-19 patients admitted into Xiangya Hospital of Central South University (in Changsha, Hunan) and Xiangya Hospital of Central South University, Jiangxi (in Nanchang, Jiangxi)
Who may be able to join
- Age greater than or equal to 65 years old;
- COVID-19 was diagnosed with SARS-CoV-2 reverse transcription-polymerase chain reaction positive or rapid antigen test positive or a clinical diagnosis made by the radiological responsible clinician based on signs, symptoms, or radiology consistent with COVID-19;
- Hospitalization more than one day, including patients in emergency.
Who cannot join
- Age less than 65 years old;
- Pregnancy;
- Hospitalization less than one day;
- Outpatients;
- Patients with missing or incomplete information.
Trial locations and contacts
1 site in 1 country.
China1 site
Xiangya Hospital of Central South University
Changsha, Hunan, 410000
About this study
Official title: Construction and Validation of a Predictive Model of Coinfections in Elderly COVID-19 Patients After Abandoning Zero Policy
The goal of this observational study is to learn about the clinical characteristics and construction of a predictive model in elderly COVID-19 patients. The main question it aims to answer is the main clinical characteristics and risk factors of elderly COVID-19 patients. Participants will not be asked to do any other intervening measure.
- Conditions
- Covid19
- Keywords
- COVID-19, elderly, nomogram, coinfections, diagnosis
- Medical subject headings
- COVID-19, Coinfection, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| elderly COVID-19 patients with coinfection | Not described | |
| elderly COVID-19 without coinfection | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coinfection
The investigators defined coinfection as coinfected bacteria, fungi, or other viruses with SARS-CoV-2 that occurred from admission to 7 days after admission. If a diagnosis was at the time of or within the first 48 hours of COVID-19 hospital admission, these infections were defined as community-acquired infections. If diagnosis occurred ≥48 hours to 7 days after admission for COVID-19, these infections were defined as early-onset hospital-acquired infections.
Measured: from admission to 7 days after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start20 Dec 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
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.
- More trials run by Xiangya Hospital of Central South UniversityThe 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
- Prospective
- Enrolment
- 1,000 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06321367
- Sponsor's protocol ID
- 202401002
- Other IDs
- 82070613, 82370638, 2022RC1212, 2023JJ10095
- Status last verified
- Mar 2024
- First submitted
- 19 Mar 2024
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Validation of a Predictive Model of Coinfections in Elderly COVID-19 Patients After Abandoning Zero Policy
- ClinicalTrials.gov ID
- NCT06321367
- Acronym / sponsor ID
- 202401002
- Conditions
- Covid19
- Keywords
- COVID-19, elderly, nomogram, coinfections, diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 20 Mar 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.
The goal of this observational study is to learn about the clinical characteristics and construction of a predictive model in elderly COVID-19 patients. The main question it aims to answer is the main clinical characteristics and risk factors of elderly COVID-19 patients. Participants will not be asked to do any other intervening measure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| elderly COVID-19 patients with coinfection | – | – |
| elderly COVID-19 without coinfection | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elderly COVID-19 patients admitted into Xiangya Hospital of Central South University (in Changsha, Hunan) and Xiangya Hospital of Central South University, Jiangxi (in Nanchang, Jiangxi)
Key inclusion criteria (3 listed)
- Age greater than or equal to 65 years old;
- COVID-19 was diagnosed with SARS-CoV-2 reverse transcription-polymerase chain reaction positive or rapid antigen test positive or a clinical diagnosis made by the radiological responsible clinician based on signs, symptoms, or radiology consistent with COVID-19;
- Hospitalization more than one day, including patients in emergency.
Key exclusion criteria (5 listed)
- Age less than 65 years old;
- Pregnancy;
- Hospitalization less than one day;
- Outpatients;
- Patients with missing or incomplete information.
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
Coinfection
Time frame: from admission to 7 days after admission
The investigators defined coinfection as coinfected bacteria, fungi, or other viruses with SARS-CoV-2 that occurred from admission to 7 days after admission. If a diagnosis was at the time of or within the first 48 hours of COVID-19 hospital admission, these infections were defined as community-acquired infections. If diagnosis occurred ≥48 hours to 7 days after admission for COVID-19, these infections were defined as early-onset hospital-acquired infections.
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 Mar 2024.
- Individual participant dataSharing planned: No
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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 Xiangya Hospital of Central South University at 1 site in China.
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 3 inclusion and 5 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 Mar 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 China. 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?
Coinfection (time frame: from admission to 7 days after admission). 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 Mar 2024.