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;

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: COVID-19

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.

• Study Type: Observational
• Enrollment (Anticipated): 1144

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Huashan Hospital affiliated to Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Jiming Zhang
• Investigators: Study Director: Jiming Zhang, PhD, Huashan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Anticipated): March 20, 2023
• Study Completion (Anticipated): March 20, 2023

Study Registration Dates

• First Submitted: February 12, 2023
• First Submitted That Met QC Criteria: February 24, 2023
• First Posted (Estimate): February 28, 2023

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 24, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Reinfection; risk factor; clinical severity
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence; Reinfection
• Other Study ID Numbers: 2022-721

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: The time period for data sharing begins nine months and ends 36 months following article publication.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No