Symptom Spectrum and Risk Factors for FeverNCT06463821
Symptom Spectrum and Risk Factors for Fever in Pediatric and Adult Patients With Omicron Infection
An observational study of Symptom Spectrum and Risk Factors for Fever, run by Shanghai Children's Medical Center at 1 site in China.
Trial summary
The omicron variant of coronavirus disease 2019 (COVID-19) has caused a global epidemic in 2022. The aim was to investigate the symptom spectrum and risk factors for fever in pediatric and adult patients with omicron infection. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Symptom Spectrum and Risk Factors for Fever
- What is being tested?
- observational questionnaires
- How many people
- 2,591 participants
- Where
- 1 siteChina
- Study dates
- 8 Apr 2022to 17 May 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who attended the child-parent sections of the Fangcang shelter hospitals in Shanghai, China, with laboratory-confirmed COVID-19
Who may be able to join
- hospitalized in the child-parent sections of the Fangcang shelter hospitals in Shanghai, China
- diagnosis of laboratory-confirmed COVID-19
Who cannot join
- ● have poor compliance (defined as inability to comply with the protocol)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Symptom Spectrum and Risk Factors for Fever in Pediatric and Adult Patients With Omicron Infection: a Prospective Observational Study
The omicron variant of coronavirus disease 2019 (COVID-19) has caused a global epidemic in 2022. The aim was to investigate the symptom spectrum and risk factors for fever in pediatric and adult patients with omicron infection. From April 8, 2022 to May 17, 2022, this prospective observational study included patients who attended the child-parent sections of the Fangcang shelter hospitals with laboratory-confirmed COVID-19. Patient data were collected from questionnaires. The risk factors for prolonged fever and high fever were identified by univariate and multivariate analyses.
Read the detailed description
Study design and participants A prospective multicenter study was designed. It was conducted in accordance with the Declaration of Helsinki (as revised in 2013). Informed consent was obtained for all participants. From April 8, 2022 to May 17, 2022, Patients who attended the child-parent sections of the Fangcang shelter hospitals in Shanghai, China, with laboratory-confirmed COVID-19 were included. Those who had poor compliance (defined as inability to comply with the protocol) were excluded. Data from the included cases were collected. Adult patients and caregivers of children patients received two kinds of questionnaires after admission. Type I questionnaire (supplemental material) for basic characteristic were finished as soon as they were admitted. Type II questionnaire (supplemental material) for symptom and medication use tracking were filled out every day until discharge. This study was approved by the ethics committee of Shanghai Children's Medical Center.
Definition of outcomes The outcomes were the likelihood of developing prolonged fever and the likelihood of developing high fever. Fever was defined as temperature ≥ 38.0℃. Prolonged fever was defined as fever for more than 2 days. High fever was defined as temperature ≥ 39.1℃.
Statistical analysis SPSS version 25.0 (IBM SPSS Statistics, Armonk, NY, USA) was used to analyze the data. Data are presented as median values and interquartile ranges (IQRs) for continuous variables and frequencies and percentages for categorical variables. The investigators used Mann-Whitney U test to compare continuous variables between two groups. The investigators used χ2 test or Fisher exact test to compare categorical variables. Univariable analysis was used to investigate the association of each clinical variable with the outcomes. To determine the risk factors for each outcome, multivariable analysis was performed by logistic regression with a stepwise variable model. Variables of P value < 0.05 were candidates for multivariable analysis. Statistical significance was determined as a 2-sided P value of < 0.05.
- Being tested
- observational questionnaires
- Keywords
- COVID-19, omicron, symptom spectrum, fever, vaccination, antipyretic
- Medical subject headings
- COVID-19, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational questionnairesOther
Patient data were collected from questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| pediatric patients | pediatric patients who attended the child-parent sections of the Fangcang shelter hospitals with laboratory-confirmed COVID-19 Receives: Other: observational questionnaires | |
| adult patients | adult patients who attended the child-parent sections of the Fangcang shelter hospitals with laboratory-confirmed COVID-19 Receives: Other: observational questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with prolonged fever or high fever
Fever's defined as temperature ≥ 38.0℃. Prolonged fever's defined as fever for more than 2 days. High fever's defined as temperature ≥ 39.1℃. Questionnaires for basic characteristic're finished as soon as they're admitted. Questionnaires for symptom and medication use tracking're filled out every day until discharge. The risk factors for prolonged fever and high fever're identified by univariate and multivariate analyses.
Measured: From April 8, 2022 to May 17, 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start8 Apr 2022
- Primary completion17 May 2022
- Study completion17 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptom Spectrum and Risk Factors for FeverStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 2,591 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463821
- Sponsor's protocol ID
- SCMCIRB-K2022040-1
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 18 Jun 2024
- Results posted
- No
- 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 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom Spectrum and Risk Factors for Fever in Pediatric and Adult Patients With Omicron Infection: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06463821
- Acronym / sponsor ID
- SCMCIRB-K2022040-1
- Keywords
- COVID-19, omicron, symptom spectrum, fever, vaccination, antipyretic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,591 participants (actual)
- Lead sponsor
- Shanghai Children's Medical CenterUniversity, hospital or other
- Study start
- 8 Apr 2022 (actual)
- Primary completion
- 17 May 2022 (actual)
- Study completion
- 17 May 2022 (actual)
- First posted
- 18 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.
The omicron variant of coronavirus disease 2019 (COVID-19) has caused a global epidemic in 2022. The aim was to investigate the symptom spectrum and risk factors for fever in pediatric and adult patients with omicron infection. From April 8, 2022 to May 17, 2022, this prospective observational study included patients who attended the child-parent sections of the Fangcang shelter hospitals with laboratory-confirmed COVID-19. Patient data were collected from questionnaires. The risk factors for prolonged fever and high fever were identified by univariate and multivariate analyses.
Detailed description
Study design and participants A prospective multicenter study was designed. It was conducted in accordance with the Declaration of Helsinki (as revised in 2013). Informed consent was obtained for all participants. From April 8, 2022 to May 17, 2022, Patients who attended the child-parent sections of the Fangcang shelter hospitals in Shanghai, China, with laboratory-confirmed COVID-19 were included. Those who had poor compliance (defined as inability to comply with the protocol) were excluded. Data from the included cases were collected. Adult patients and caregivers of children patients received two kinds of questionnaires after admission. Type I questionnaire (supplemental material) for basic characteristic were finished as soon as they were admitted. Type II questionnaire (supplemental material) for symptom and medication use tracking were filled out every day until discharge. This study was approved by the ethics committee of Shanghai Children's Medical Center.
Definition of outcomes The outcomes were the likelihood of developing prolonged fever and the likelihood of developing high fever. Fever was defined as temperature ≥ 38.0℃. Prolonged fever was defined as fever for more than 2 days. High fever was defined as temperature ≥ 39.1℃.
Statistical analysis SPSS version 25.0 (IBM SPSS Statistics, Armonk, NY, USA) was used to analyze the data. Data are presented as median values and interquartile ranges (IQRs) for continuous variables and frequencies and percentages for categorical variables. The investigators used Mann-Whitney U test to compare continuous variables between two groups. The investigators used χ2 test or Fisher exact test to compare categorical variables. Univariable analysis was used to investigate the association of each clinical variable with the outcomes. To determine the risk factors for each outcome, multivariable analysis was performed by logistic regression with a stepwise variable model. Variables of P value < 0.05 were candidates for multivariable analysis. Statistical significance was determined as a 2-sided P value of < 0.05.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pediatric patients | – | Other: observational questionnairespediatric patients who attended the child-parent sections of the Fangcang shelter hospitals with laboratory-confirmed COVID-19 |
| adult patients | – | Other: observational questionnairesadult patients who attended the child-parent sections of the Fangcang shelter hospitals with laboratory-confirmed COVID-19 |
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who attended the child-parent sections of the Fangcang shelter hospitals in Shanghai, China, with laboratory-confirmed COVID-19
Key inclusion criteria (2 listed)
- hospitalized in the child-parent sections of the Fangcang shelter hospitals in Shanghai, China
- diagnosis of laboratory-confirmed COVID-19
Key exclusion criteria (1 listed)
- ● have poor compliance (defined as inability to comply with the protocol)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational questionnairesPatient data were collected from questionnaires. | Other | adult patients, pediatric patients |
Primary outcome
Number of Participants with prolonged fever or high fever
Time frame: From April 8, 2022 to May 17, 2022
Fever's defined as temperature ≥ 38.0℃. Prolonged fever's defined as fever for more than 2 days. High fever's defined as temperature ≥ 39.1℃. Questionnaires for basic characteristic're finished as soon as they're admitted. Questionnaires for symptom and medication use tracking're filled out every day until discharge. The risk factors for prolonged fever and high fever're identified by univariate and multivariate analyses.
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 18 Jun 2024.
- Individual participant dataSharing planned: No
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 Symptom Spectrum and Risk Factors for Fever, run by Shanghai Children's Medical Center 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 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 18 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 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?
Number of Participants with prolonged fever or high fever (time frame: From April 8, 2022 to May 17, 2022). 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 18 Jun 2024.