Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-25 @ 1:21 AM
NCT ID:
NCT05774093
Brief Summary:
The goal of this observational study is to evaluate the protective effect of immune barrier on secondary infection after COVID-19 (coronavirus disease 2019) vaccination or COVID-19 virus Omicron B A. 5.2 strain infection by dynamically monitoring the COVID-19 antibody titer, cellular immune function and the occurrence of secondary infection of healthy participants, mainly medical staff in our hospital, to understand the cross protective effect of COVID-19 antibody on different variants of Omicron, and explore the best time to use COVID-19 vaccine to strengthen immunity after Omicron mutant infection.
Detailed Description:
This study is a single center, prospective, non-intervention study. It is planned to recruit 300 medical and nursing participants, administrative and logistics participants or other participants who can cooperate with the follow-up for 48 weeks to voluntarily join the group.
Participants will be investigated about the vaccination history of COVID-19 vaccine, whether they have ever been infected with COVID-19, the time of initial infection with COVID-19, and following clinical symptoms.The COVID-19 antibody titer of peripheral blood will be used for baseline.
The participants will be divided into positive group and negative group according to the COVID-19 antibody titer results,then they wii be followed up for 48 weeks.If the participants have no symptoms related to COVID-19 infection, COVID-19 antibody and COVID-19 nucleic acid will be tested every 4-8 weeks according to the epidemic situation (the specific visit time is initially set as 0 week, 6 ± 2 weeks, 12 ± 4 weeks, 20 ± 4 weeks, 28 ± 4 weeks, 36 ± 4 weeks, 48 ± 4 weeks). There will be about 7 visits in total, according to the epidemic situation and the time of secondary infection of the participants). If the nucleic acid turns to be positive, we will consider it as the asymptomatic infection, then we will collect nasal/pharyngeal swabs for gene sequencing of virus strains, and terminate the study.
If the participants get fever, fatigue, sore throat, cough, nasal congestion, runny nose, muscle soreness or headache and other symptoms related to COVID-19 infection during the study period, they need to test the COVID-19 antigen or COVID-19 nucleic acid within 48 hours. If it is positive, we will collect nasal/pharyngeal swabs for gene sequencing of virus strains, and terminate the study in advance.
Study:
NCT05774093
Study Brief:
Protocol Section:
NCT05774093