Characteristics of SARS-CoV-2 Reinfection

February 24, 2023 updated by: Jiming Zhang

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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1144

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Characteristics of all enrolled SARS-CoV-2 patients during two periods.
Time Frame: 2022-12~2023-2
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.
Time Frame: 2022-12~2023-2
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
Time Frame: 2022-12~2023-2
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiming Zhang

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jiming Zhang, PhD, Huashan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 20, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 20, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2023

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2023

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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