Symptom Spectrum and Risk Factors for Fever in Pediatric and Adult Patients With Omicron Infection

NCT06463821 | Completed

• 1 other identifier: SCMCIRB-K2022040-1
• Study Type: observational
• Target: 2,591
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Symptom Spectrum and Risk Factors for Fever

Keywords

COVID-19, omicron, symptom spectrum, fever, vaccination, antipyretic

Outcome Measures

Primary Outcomes (1)

• 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.

  From April 8, 2022 to May 17, 2022

Study Arms (2)

pediatric patients

pediatric patients who attended the child-parent sections of the Fangcang shelter hospitals with laboratory-confirmed COVID-19

Other: observational questionnaires

adult patients

adult patients who attended the child-parent sections of the Fangcang shelter hospitals with laboratory-confirmed COVID-19

Other: observational questionnaires

Interventions

observational questionnaires OTHER

Patient data were collected from questionnaires.

adult patients; pediatric patients

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who attended the child-parent sections of the Fangcang shelter hospitals in Shanghai, China, with laboratory-confirmed COVID-19

You may qualify if:

• hospitalized in the child-parent sections of the Fangcang shelter hospitals in Shanghai, China
• diagnosis of laboratory-confirmed COVID-19

You may not qualify if:

• ● have poor compliance (defined as inability to comply with the protocol)

Sponsors & Collaborators

• Shanghai Children's Medical Center: lead

Study Sites (1)

child-parent sections of the Fangcang shelter hospitals

Shanghai, China

Location

MeSH Terms

Conditions

COVID-19; Fever

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 18, 2024
• Study Start: April 8, 2022
• Primary Completion: May 17, 2022
• Study Completion: May 17, 2022
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)