Clinical trial NCT05748262: Characteristics of SARS-CoV-2 Reinfection
Official title: 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;
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Keywords: Reinfection
risk factor
clinical severity
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 1144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Detailed description: The investigators used data from Huashan Hospital, Renji Hospital, and Shanghai Jing' an Central Hospital to collect information on SARS-CoV-2 primary infections with BA.2 during 1 March to 23 May 2022, and followed up for participants' reinfections with BA.5-lineages during 1 December 2022 to 14 January 2023. After matched 1:1 by age and gender with the reinfection cohort, data of primary infections with BA.5-sublineages were also collected. Reinfection cases were defined as having positive COVID-19 PCR or antigen test, at least 90 days after participants' first positive testing. Basic information, vaccination status, time interval between two infections, and clinical manifestations were collected.

Eligibility criteria: Inclusion Criteria:

* All PCR- or RAT-confirmed SARS-CoV-2 reinfections were included in the study.

Exclusion Criteria:

* Patients who did not know if they were reinfected were excluded.

Primary outcomes:
measure: Characteristics of all enrolled SARS-CoV-2 patients during two periods.
timeFrame: 2022-12~2023-2
measure: 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.
timeFrame: 2022-12~2023-2
measure: Clinical characteristics of SARS-CoV-2 primary infection and reinfection among patients with reinfection in Shanghai
timeFrame: 2022-12~2023-2
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital Affiliated to Fudan University
Study officials:
affiliation: Huashan Hospital
name: Jiming Zhang, PhD
role: STUDY_DIRECTOR
References: