Characteristics of SARS-CoV-2 Reinfection

COVID-19 Clinical Trial

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;

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05748262
• Other study ID #: 2022-721
• Status: Enrolling by invitation
• Start date: December 15, 2022
• Est. completion date: March 20, 2023

Study information

• Verified date: February 2023
• Source: Huashan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1144
• Est. completion date: March 20, 2023
• Est. primary completion date: March 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
China	Huashan Hospital Affiliated to Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiming Zhang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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