COVID-19 InfectionCOVIDNCT05774093
Evaluation of COVID-19 Immune Barrier and Reinfection Risk
An observational study of COVID-19 Infection and Immunization; Infection, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Infection, Immunization; Infection
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 6 Mar 2023to 31 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The participants need to be sure whether they have ever been infected with COVID-19, and need to be clearly remember the time when they first infected with COVID-19.
Who may be able to join
- No age limit, no gender limit;
- Medical staff, administrative and logistics staff who work in the Third Affiliated Hospital of Sun Yat-Sen University or other participants who can cooperate with the follow-up for 48 weeks;
- The participants need to be sure whether they have ever been infected with COVID-19, and need to be clearly remember the time when they first infected with COVID-19.
Who cannot join
- Have the following serious respiratory diseases: such as asthma, bronchiectasis, chronic obstructive pulmonary disease, pulmonary interstitial disease, tuberculosis and other respiratory diseases that may interfere with symptom observation;
- Those with other serious diseases or disease history that affect immune function, including but not limited to uncontrolled and unresectable malignant tumors,hematological diseases, cachexia, active bleeding, severe malnutrition, mental diseases, autoimmune diseases, HIV, etc.
- Those who have long-term assignment plans and cannot return to the hospital regularly for follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Liang Bing Lin, MD, 13924129928, lamikin@126.com
Ying Zi Lei, MD, 13560440923, leiziy@mail.sysu.edu.cn
About this study
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.
Read the 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.
- Conditions
- COVID-19 Infection, Immunization; Infection
- Medical subject headings
- COVID-19, Infections
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 |
|---|---|---|
| COVID-19 Antibody Group 1 | Participants will be divided into positive group and negative group according to the baseline of COVID-19 antibody titer.Group 1 is for those COVID-19 antibody are positive. | |
| COVID-19 Antibody Group 2 | Participants will be divided into positive group and negative group according to the baseline of COVID-19 antibody titer.Group 1 is for those COVID-19 antibody are negative. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of COVID-19 reinfection in COVID-19 antibody positive and negative groups.
This study is an observational study. The incidence of COVID-19 reinfection is mainly based on the participants with positive COVID-19 nucleic acid test. The proportion of participants with positive COVID-19 nucleic acid test in the total number during the observation period after 48 weeks observation will be counted.
Measured: 48weeks
Secondary outcomes (5)
Dynamic changes of COVID-19 antibody titer in 48 weeks after COVID-19 infection.
We will test COVID-19 antibody every 4-8 weeks and record the data to observe the dynamic change of titer.
Measured: 48weeks
Dynamic changes of cellular immune function in 48 weeks after COVID-19 infection.
Flow cytometry will be used to detect the cellular immune function of participants every 4-8 weeks, and record data to analyze its dynamic changes.
Measured: 48weeks
Antibody titer of COVID-19 in uninfected persons.
The "uninfected person" refers to the participant who is still uninfected with COVID-19 at the end of our study. We will record and analyze the dynamic change of COVID-19 antibody titer within 48 weeks.
Measured: 48weeks
The cellular immune function of COVID-19 in uninfected persons.
We will record and analyze the dynamic change of the cellular immune function by flow-cytometry within 48 weeks.
Measured: 48weeks
The change of antibody titer in uninfected people after COVID-19 vaccine.
We will test and analyze the changes of COVID-19 antibody titer of uninfected people within 48 weeks after the booster immunization with COVID-19 vaccine.
Measured: 48weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start6 Mar 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVID-19 InfectionStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Bingliang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774093
- Sponsor's protocol ID
- COVID-19 Immune Barrier Study
- Acronym
- COVID
- Status last verified
- Mar 2023
- First submitted
- 12 Mar 2023
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hall VJ, Foulkes S, Charlett A, Atti A, Monk EJM, Simmons R, Wellington E, Cole MJ, Saei A, Oguti B, Munro K, Wallace S, Kirwan PD, Shrotri M, Vusirikala A, Rokadiya S, Kall M, Zambon M, Ramsay M, Brooks T, Brown CS, Chand MA, Hopkins S; SIREN Study Group. SARS-CoV-2 infection rates of antibody-positive compared with antibody-negative health-care workers in England: a large, multicentre, prospective cohort study (SIREN). Lancet. 2021 Apr 17;397(10283):1459-1469. doi: 10.1016/S0140-6736(21)00675-9. Epub 2021 Apr 9.
PubMed 33844963Michlmayr D, Hansen CH, Gubbels SM, Valentiner-Branth P, Bager P, Obel N, Drewes B, Moller CH, Moller FT, Legarth R, Molbak K, Ethelberg S. Observed protection against SARS-CoV-2 reinfection following a primary infection: A Danish cohort study among unvaccinated using two years of nationwide PCR-test data. Lancet Reg Health Eur. 2022 Sep;20:100452. doi: 10.1016/j.lanepe.2022.100452. Epub 2022 Jun 30.
PubMed 35791335Servellita V, Syed AM, Morris MK, Brazer N, Saldhi P, Garcia-Knight M, Sreekumar B, Khalid MM, Ciling A, Chen PY, Kumar GR, Gliwa AS, Nguyen J, Sotomayor-Gonzalez A, Zhang Y, Frias E, Prostko J, Hackett J Jr, Andino R, Wadford DA, Hanson C, Doudna J, Ott M, Chiu CY. Neutralizing immunity in vaccine breakthrough infections from the SARS-CoV-2 Omicron and Delta variants. Cell. 2022 Apr 28;185(9):1539-1548.e5. doi: 10.1016/j.cell.2022.03.019. Epub 2022 Mar 18.
PubMed 35429436
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of COVID-19 Immune Barrier and Reinfection Risk
- ClinicalTrials.gov ID
- NCT05774093
- Acronym / sponsor ID
- COVID / COVID-19 Immune Barrier Study
- Conditions
- COVID-19 Infection, Immunization; Infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 17 Mar 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Antibody Group 1 | – | –Participants will be divided into positive group and negative group according to the baseline of COVID-19 antibody titer.Group 1 is for those COVID-19 antibody are positive. |
| COVID-19 Antibody Group 2 | – | –Participants will be divided into positive group and negative group according to the baseline of COVID-19 antibody titer.Group 1 is for those COVID-19 antibody are negative. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The participants need to be sure whether they have ever been infected with COVID-19, and need to be clearly remember the time when they first infected with COVID-19.
Key inclusion criteria (3 listed)
- No age limit, no gender limit;
- Medical staff, administrative and logistics staff who work in the Third Affiliated Hospital of Sun Yat-Sen University or other participants who can cooperate with the follow-up for 48 weeks;
- The participants need to be sure whether they have ever been infected with COVID-19, and need to be clearly remember the time when they first infected with COVID-19.
Key exclusion criteria (3 listed)
- Have the following serious respiratory diseases: such as asthma, bronchiectasis, chronic obstructive pulmonary disease, pulmonary interstitial disease, tuberculosis and other respiratory diseases that may interfere with symptom observation;
- Those with other serious diseases or disease history that affect immune function, including but not limited to uncontrolled and unresectable malignant tumors,hematological diseases, cachexia, active bleeding, severe malnutrition, mental diseases, autoimmune diseases, HIV, etc.
- Those who have long-term assignment plans and cannot return to the hospital regularly for follow-up.
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
The incidence of COVID-19 reinfection in COVID-19 antibody positive and negative groups.
Time frame: 48weeks
This study is an observational study. The incidence of COVID-19 reinfection is mainly based on the participants with positive COVID-19 nucleic acid test. The proportion of participants with positive COVID-19 nucleic acid test in the total number during the observation period after 48 weeks observation will be counted.
5 secondary outcomes
Dynamic changes of COVID-19 antibody titer in 48 weeks after COVID-19 infection.
Time frame: 48weeks
Dynamic changes of cellular immune function in 48 weeks after COVID-19 infection.
Time frame: 48weeks
Antibody titer of COVID-19 in uninfected persons.
Time frame: 48weeks
The cellular immune function of COVID-19 in uninfected persons.
Time frame: 48weeks
The change of antibody titer in uninfected people after COVID-19 vaccine.
Time frame: 48weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Results publication: PubMed 33844963Hall VJ, Foulkes S, Charlett A, Atti A, Monk EJM, Simmons R, Wellington E, Cole MJ, Saei A, Oguti B, Munro K, Wallace S, Kirwan PD, Shrotri M, Vusirikala A, Rokadiya S, Kall M, Zambon M, Ramsay M, Brooks T, Brown CS, Chand MA, Hopkins S; SIREN Study Group. SARS-CoV-2 infection rates of antibody-positive compared with antibody-negative health-care workers in England: a large, multicentre, prospective cohort study (SIREN). Lancet. 2021 Apr 17;397(10283):1459-1469. doi: 10.1016/S0140-6736(21)00675-9. Epub 2021 Apr 9.
- Results publication: PubMed 35791335Michlmayr D, Hansen CH, Gubbels SM, Valentiner-Branth P, Bager P, Obel N, Drewes B, Moller CH, Moller FT, Legarth R, Molbak K, Ethelberg S. Observed protection against SARS-CoV-2 reinfection following a primary infection: A Danish cohort study among unvaccinated using two years of nationwide PCR-test data. Lancet Reg Health Eur. 2022 Sep;20:100452. doi: 10.1016/j.lanepe.2022.100452. Epub 2022 Jun 30.
- Results publication: PubMed 35429436Servellita V, Syed AM, Morris MK, Brazer N, Saldhi P, Garcia-Knight M, Sreekumar B, Khalid MM, Ciling A, Chen PY, Kumar GR, Gliwa AS, Nguyen J, Sotomayor-Gonzalez A, Zhang Y, Frias E, Prostko J, Hackett J Jr, Andino R, Wadford DA, Hanson C, Doudna J, Ott M, Chiu CY. Neutralizing immunity in vaccine breakthrough infections from the SARS-CoV-2 Omicron and Delta variants. Cell. 2022 Apr 28;185(9):1539-1548.e5. doi: 10.1016/j.cell.2022.03.019. Epub 2022 Mar 18.
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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.
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 Infection and Immunization; Infection, run by Sun Yat-sen University 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 17 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of COVID-19 reinfection in COVID-19 antibody positive and negative groups. (time frame: 48weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05774093, which also lists 3 linked publications.
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 17 Mar 2023.