Characteristics of SARS-CoV-2 Reinfection
Department of Infectious Diseases, Shanghai Key Laboratory of Infectious Diseases and Biosafety Emergency Response, National Medical Center for Infectious Diseases, Huashan Hospital, Fudan University, Shanghai, China;
1 other identifier
observational
1,144
1 country
1
Brief Summary
As the COVID-19 pandemic continues and the number of individuals with previous infection rises, numbers of SARS-CoV-2 reinfection are increasing. The second Omicron wave in Shanghai, China caused by BA.5-sublineages led to a large fraction of reinfections among BA.2 primary infections. To better understand the SARS-CoV-2 reinfection rate and clinical severity of reinfections, the investigators conducted a multi-centre cohort study. The investigators hope to provide valuable clinical evidences for reinfections and offer guidance for future policy making.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 15, 2022
CompletedFirst Submitted
Initial submission to the registry
February 12, 2023
CompletedFirst Posted
Study publicly available on registry
February 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2023
CompletedFebruary 28, 2023
February 1, 2023
3 months
February 12, 2023
February 24, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Characteristics of all enrolled SARS-CoV-2 patients during two periods.
Basic information, vaccination status, time interval between two infections, and clinical manifestations
2022-12~2023-2
Characteristics and multivariate analysis of risk factors for SARS-CoV-2 reinfection by gender, age, vaccination status, clinical severity and Ct values of primary infection.
Sex, age, vaccination status, clinical severity of primary infection, and Ct values during primary infection
2022-12~2023-2
Clinical characteristics of SARS-CoV-2 primary infection and reinfection among patients with reinfection in Shanghai
Fever, fatigue, sore throat, cough, anosmia and/or ageusia, muscle and/or joint pain, headache, chest congestion, diarrhea, runny nose, sleeping disorders, and pneumonia
2022-12~2023-2
Study Arms (2)
Primary infections during March-May 2022
Hospitalized COVID-19 patients infected with BA·2 during 1 March to 23 May 2022 from Huashan Hospital, Renji Hospital, and Shanghai Jing' an Central Hospital.
Primary infections during December 2022-January 2023
Primary infections with BA.5-sublineages during 1 December 2022 to 14 January 2023, matched 1:1 by age and sex with reinfections during the same period.
Eligibility Criteria
A Primary SARS-CoV-2 infection was defined as having a positive PCR test result for the first time. A suspect SARS-CoV-2 reinfection (generally referred as reinfection in this paper) was defined as having a positive PCR of RAT sample over 90 days following primary infection.
You may qualify if:
- All PCR- or RAT-confirmed SARS-CoV-2 reinfections were included in the study.
You may not qualify if:
- Patients who did not know if they were reinfected were excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jiming Zhanglead
Study Sites (1)
Huashan Hospital Affiliated to Fudan University
Shanghai, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jiming Zhang, PhD
Huashan Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
February 12, 2023
First Posted
February 28, 2023
Study Start
December 15, 2022
Primary Completion
March 20, 2023
Study Completion
March 20, 2023
Last Updated
February 28, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- The time period for data sharing begins nine months and ends 36 months following article publication.
- Access Criteria
- Data is available with investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for individual participant data meta-analysis.
Individual participant data (including data dictionaries) will be available. Individual participant data that underlie the results reported in this article will be shared after de-identification (text, tables, figures, and appendices). Study protocol will also be available. The time period for data sharing begins nine months and ends 36 months following article publication. Data is available with investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for individual participant data meta-analysis. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our university's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at https://yxky.fudan.edu.cn.