COVID-19NCT05748262
Characteristics of SARS-CoV-2 Reinfection
An observational study of COVID-19, run by Jiming Zhang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- COVID-19
- How many people
- 1,144 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2022to 20 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All PCR- or RAT-confirmed SARS-CoV-2 reinfections were included in the study.
Who cannot join
- Patients who did not know if they were reinfected were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
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;
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.
Read the 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.
- Conditions
- COVID-19
- Keywords
- Reinfection, risk factor, clinical severity
- Medical subject headings
- COVID-19, Reinfection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Characteristics of all enrolled SARS-CoV-2 patients during two periods.
Basic information, vaccination status, time interval between two infections, and clinical manifestations
Measured: 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
Measured: 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
Measured: 2022-12~2023-2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start15 Dec 2022
- Primary completion20 Mar 2023 (estimated)
- Study completion20 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiming Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jiming Zhang, Huashan Hospital
- Investigators
- Jiming Zhang, PhD, Study director, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748262
- Sponsor's protocol ID
- 2022-721
- Status last verified
- Feb 2023
- First submitted
- 12 Feb 2023
- Last updated
- 28 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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;
- ClinicalTrials.gov ID
- NCT05748262
- Acronym / sponsor ID
- 2022-721
- Conditions
- COVID-19
- Keywords
- Reinfection, risk factor, clinical severity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,144 participants (estimated)
- Lead sponsor
- Jiming ZhangUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 20 Mar 2023 (estimated)
- Study completion
- 20 Mar 2023 (estimated)
- First posted
- 28 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All PCR- or RAT-confirmed SARS-CoV-2 reinfections were included in the study.
Key exclusion criteria (1 listed)
- Patients who did not know if they were reinfected were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiming Zhang, PhD study director
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Jiming Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characteristics of all enrolled SARS-CoV-2 patients during two periods. (time frame: 2022-12~2023-2). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.