COVID-19NCT05680896
SARS-CoV-2 Infection Among Healthcare Workers
An observational study of COVID-19, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
At present, COVID-19 vaccine is considered as the safest, economic and effective measure to prevent and control COVID-19. Adaptive immunity, including humoral immunity and cellular immunity, plays a role in anti-viral responses. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- inactivated COVID-19 vaccines; orally aerosolized Ad5-nCoV
- Type of treatment
- Vaccines, Pill or oral medicine
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 22 Dec 2024
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthcare workers in Nanjing Drum Tower Hospital, Nanjing, China
Who may be able to join
- Age ≥18 years
- SARS-CoV-2 nucleic acid testing showed negative within 72 hours
Who cannot join
- 1.Do not consent to enroll in this study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
Chao Wu, PhD, dr.wu@nju.edu.cn
About this study
Official title: The Risk of SARS-CoV-2 Infection and Severity of COVID-19 Among Healthcare Workers With or Without Previous COVID-19 Vaccines
At present, COVID-19 vaccine is considered as the safest, economic and effective measure to prevent and control COVID-19. Adaptive immunity, including humoral immunity and cellular immunity, plays a role in anti-viral responses. Cellular immunity includes virus specific B cells and T cells, which can provide long-term memory immunity. For acute viral infection, neutralizing antibody is of great significance in preventing infection, while memory cell immunity can maintain a good broad-spectrum and persistence in controlling mutant strains, which is a key factor in controlling viral replication after infection and reducing severe disease and death. However, there is no systematic study on the specific immune response and infection risk of novel coronavirus, and there is no definite conclusion on which specific protective immune response induced by vaccine can reduce the risk of infection. Therefore, this study aims to establish a prospective real-world cohort, analyze the correlation between multiple baseline immune protection indicators and infection risk, follow up the population with breakthrough infection, and monitor the dynamic specific immune response to COVID-19 in peripheral blood and respiratory mucosa. This study will provide an important scientific basis for us to scientifically assess the risk of individual infection with COVID-19.
- Conditions
- COVID-19
- Being tested
- inactivated COVID-19 vaccines; orally aerosolized Ad5-nCoV
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inactivated COVID-19 vaccines; orally aerosolized Ad5-nCoVBiological
the protection of COVID-19 vaccines on breakthrough infection
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2 infection
SARS-CoV-2 infection confirmed by either by nucleic acid testing or antigen testing
Measured: from Dec 2022 to April 2023
The severity of COVID-19
the severity of COVID-19 symptoms including the period from SARS-CoV-2 positive to negative, fever days, etc.
Measured: from Dec 2022 to April 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start1 Feb 2023 (estimated)
- Primary completion21 Mar 2023 (estimated)
- Study completion22 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chao Wu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Chao Wu, Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680896
- Sponsor's protocol ID
- 20222-746
- Status last verified
- Jan 2023
- First submitted
- 22 Dec 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chen Y, Zhao T, Chen L, Jiang G, Geng Y, Li W, Yin S, Tong X, Tao Y, Ni J, Lu Q, Ning M, Wu C. SARS-CoV-2 Omicron infection augments the magnitude and durability of systemic and mucosal immunity in triple-dose CoronaVac recipients. mBio. 2024 Apr 10;15(4):e0240723. doi: 10.1128/mbio.02407-23. Epub 2024 Mar 8.
PubMed 38456703
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Risk of SARS-CoV-2 Infection and Severity of COVID-19 Among Healthcare Workers With or Without Previous COVID-19 Vaccines
- ClinicalTrials.gov ID
- NCT05680896
- Acronym / sponsor ID
- 20222-746
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 21 Mar 2023 (estimated)
- Study completion
- 22 Dec 2024 (estimated)
- First posted
- 11 Jan 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.
At present, COVID-19 vaccine is considered as the safest, economic and effective measure to prevent and control COVID-19. Adaptive immunity, including humoral immunity and cellular immunity, plays a role in anti-viral responses. Cellular immunity includes virus specific B cells and T cells, which can provide long-term memory immunity. For acute viral infection, neutralizing antibody is of great significance in preventing infection, while memory cell immunity can maintain a good broad-spectrum and persistence in controlling mutant strains, which is a key factor in controlling viral replication after infection and reducing severe disease and death. However, there is no systematic study on the specific immune response and infection risk of novel coronavirus, and there is no definite conclusion on which specific protective immune response induced by vaccine can reduce the risk of infection. Therefore, this study aims to establish a prospective real-world cohort, analyze the correlation between multiple baseline immune protection indicators and infection risk, follow up the population with breakthrough infection, and monitor the dynamic specific immune response to COVID-19 in peripheral blood and respiratory mucosa. This study will provide an important scientific basis for us to scientifically assess the risk of individual infection with COVID-19.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthcare workers in Nanjing Drum Tower Hospital, Nanjing, China
Key inclusion criteria (2 listed)
- Age ≥18 years
- SARS-CoV-2 nucleic acid testing showed negative within 72 hours
Key exclusion criteria (1 listed)
- 1.Do not consent to enroll in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inactivated COVID-19 vaccines; orally aerosolized Ad5-nCoVthe protection of COVID-19 vaccines on breakthrough infection | Biological | – |
Primary outcome
SARS-CoV-2 infection
Time frame: from Dec 2022 to April 2023
SARS-CoV-2 infection confirmed by either by nucleic acid testing or antigen testing
The severity of COVID-19
Time frame: from Dec 2022 to April 2023
the severity of COVID-19 symptoms including the period from SARS-CoV-2 positive to negative, fever days, etc.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Derived from this study: PubMed 38456703Chen Y, Zhao T, Chen L, Jiang G, Geng Y, Li W, Yin S, Tong X, Tao Y, Ni J, Lu Q, Ning M, Wu C. SARS-CoV-2 Omicron infection augments the magnitude and durability of systemic and mucosal immunity in triple-dose CoronaVac recipients. mBio. 2024 Apr 10;15(4):e0240723. doi: 10.1128/mbio.02407-23. Epub 2024 Mar 8.
- Individual participant dataSharing planned: Undecided
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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.
Chao Wu principal investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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 The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 2 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 11 Jan 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?
Contact Chao Wu, PhD (+8613809022921, dr.wu@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SARS-CoV-2 infection (time frame: from Dec 2022 to April 2023). The study lists 2 primary outcomes in all. 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 NCT05680896, which also lists 1 linked publication.
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 11 Jan 2023.