COVID-19COVID-19NCT05758675
Study on the Antibody Level Against SARS-CoV-2 （COVID-19）in Dazhu County in 2023
An observational study of COVID-19, run by Sinocelltech Ltd. at 1 site in China.
Trial summary
About 15,000 to 25,000 subjects will be screened. Their information will be collected, venous blood will be sampled, their serum antibody levels will be detected, and the incidence of COVID-19 wil be followed up. Read more about this study
- Who is it for?
- Ages 3 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- How many people
- 20,000 participants
- Where
- 1 siteChina
- Study dates
- 21 Feb 2023to 8 Dec 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 3 to 120 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Screening by sampling from natural communities.
Who may be able to join
- The age when signing ICF should be ≥3 year, male or female.
- The Subject and/or guardian or client of both parties are able to sign a written ICF and voluntarily participate in the trial, fully understand the trial procedure, the risks of participating in the study.
- Healthy subjects or subjects with stable underlying diseases. Stable underlying diseases were defined as those who were in stable condition at least 3 months before inclusion in the study, had no significant change in treatment regimen and had not been admitted to hospital due to disease progression.
Who cannot join
- a history of contraindications for venous blood collection such as thrombocytopenia or other clotting disorders.
- Current severe or uncontrollable cardiovascular disease, endocrine disease, blood and lymphatic system disease, liver and kidney disease, respiratory system disease, metabolic and skeletal system disease, or malignancy.
- If it is not in line with the benefit maximization of the subjects, the investigator determines that it is not suitable to participate in clinical research.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Dazhu County Center for Disease Control and Prevention
Dazhou, Sichuan, 635100
Bo Zhou, Bachelor's
About this study
Official title: Study on the Antibody Level Against SARS-CoV-2 in Dazhu County in 2023
About 15,000 to 25,000 subjects will be screened. Their information will be collected, venous blood will be sampled, their serum antibody levels will be detected, and the incidence of COVID-19 wil be followed up.
Read the detailed description
Data of the following will be collected:
- Demographic data,including Name, Gender, Ethnic groups, ID Card number (age automatically calculated), Height/weight (automatic BMI calculation);
- Previous disease/surgical history; 3. Previous COVID-19 infections; 4. COVID-19 vaccination history; 5. Infection after this screening; 6. Screening information for COVID-19 antibodies.
Atibody level against SARS-CoV-2 will be test.
- Conditions
- COVID-19
- Medical subject headings
- COVID-19
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 |
|---|---|---|
| ≥ 60 years old population | around 2000 subjects will be screened. | |
| 18~59 years old population | around 3000 subjects will be screened. | |
| < 18 years old | around 15000 subjects will be screened. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of antibody against SARS-CoV-2
Concentration of antibody against SARS-CoV-2 in different age groups
Measured: From Day 0 to Day 180
Secondary outcomes (1)
Relation between collected information and antibody concentration
Analysis of the correlation between the antibody level and the collected information.
Measured: From Day 0 to Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start21 Feb 2023
- Primary completion8 Sep 2023 (estimated)
- Study completion8 Dec 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
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinocelltech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bo Zhou, M.D., Principal investigator, Dazhu County Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758675
- Sponsor's protocol ID
- SCT-Dazhu-Screening-1
- Acronym
- COVID-19
- Status last verified
- Mar 2023
- First submitted
- 13 Feb 2023
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Distribution analysis and correlation analysis of antibody will be done and published in academic journals.
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Antibody Level Against SARS-CoV-2 in Dazhu County in 2023
- ClinicalTrials.gov ID
- NCT05758675
- Acronym / sponsor ID
- COVID-19 / SCT-Dazhu-Screening-1
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Sinocelltech Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 8 Sep 2023 (estimated)
- Study completion
- 8 Dec 2023 (estimated)
- First posted
- 7 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.
About 15,000 to 25,000 subjects will be screened. Their information will be collected, venous blood will be sampled, their serum antibody levels will be detected, and the incidence of COVID-19 wil be followed up.
Detailed description
Data of the following will be collected:
- Demographic data,including Name, Gender, Ethnic groups, ID Card number (age automatically calculated), Height/weight (automatic BMI calculation);
- Previous disease/surgical history; 3. Previous COVID-19 infections; 4. COVID-19 vaccination history; 5. Infection after this screening; 6. Screening information for COVID-19 antibodies.
Atibody level against SARS-CoV-2 will be test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ≥ 60 years old population | – | –around 2000 subjects will be screened. |
| 18~59 years old population | – | –around 3000 subjects will be screened. |
| < 18 years old | – | –around 15000 subjects will be screened. |
Who may qualify
- Ages
- 3 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Screening by sampling from natural communities.
Key inclusion criteria (3 listed)
- The age when signing ICF should be ≥3 year, male or female.
- The Subject and/or guardian or client of both parties are able to sign a written ICF and voluntarily participate in the trial, fully understand the trial procedure, the risks of participating in the study.
- Healthy subjects or subjects with stable underlying diseases. Stable underlying diseases were defined as those who were in stable condition at least 3 months before inclusion in the study, had no significant change in treatment regimen and had not been admitted to hospital due to disease progression.
Key exclusion criteria (3 listed)
- a history of contraindications for venous blood collection such as thrombocytopenia or other clotting disorders.
- Current severe or uncontrollable cardiovascular disease, endocrine disease, blood and lymphatic system disease, liver and kidney disease, respiratory system disease, metabolic and skeletal system disease, or malignancy.
- If it is not in line with the benefit maximization of the subjects, the investigator determines that it is not suitable to participate in clinical research.
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
Concentration of antibody against SARS-CoV-2
Time frame: From Day 0 to Day 180
Concentration of antibody against SARS-CoV-2 in different age groups
1 secondary outcome
Relation between collected information and antibody concentration
Time frame: From Day 0 to Day 180
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Individual participant dataSharing planned: No. Distribution analysis and correlation analysis of antibody will be done and published in academic journals.
Related trials for COVID-19
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Not yet recruitingPhase 3
Dapagliflozin for Long COVID Syndrome
COVID - 19, Long COVID Syndrome
RecruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruitingObservational study
Analysis of Coronavirus Disease 19 (COVID-19) Convalescent Plasma
Asymptomatic COVID-19 Infection Laboratory-Confirmed, Symptomatic COVID-19 Infection Laboratory-Confirmed
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
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.
Bo Zhou, M.D. principal investigator
Dazhu County Center for Disease Control and Prevention
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 Sinocelltech Ltd. 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: status not confirmed, as of the sponsor's last update on 8 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xinjie Yang, M.D. (86-010-58628288, xinjie_yang@sinocelltech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of antibody against SARS-CoV-2 (time frame: From Day 0 to Day 180). 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 8 Mar 2023.