COVID-19NCT05827939
Association of Phenotypic Age and Antibody Titers Among SARS-Co-V2 Infected Patients and Vaccinated Groups
An observational study of COVID-19, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Defining the antibody response to SARS-CoV-2 will be essential for understanding disease progression, long-term immunity, and vaccine efficacy. Investigators designed a study investigating the neutralizing antibody response among post-infected and post-vaccinated individuals to determine how the spike protein… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Covid19 Vaccination dose
- Type of treatment
- Vaccines
- How many people
- 330 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2022to 30 Nov 2025
- How long will I take part?
- 3 Months
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Serum samples were obtained from 3 groups of participants based on every 3-month interval. At TuCheng Hospital, infected convalescent participants were enrolled 14 days after symptom onset as the first group. Deidentified serum samples were drawn 14 days after the second dose (100-μg cohort) from participants without SARS-CoV-2 infection and post-Moderna, or AstraZeneca vaccination were enrolled as the second group. Healthy participants without SARS-CoV-2 infection were enrolled as the third group.Participants' age over 20 years old who met the enrollment criteria will be provided informed consent.These participants were prospecitvley recruited using multiple methods, including advertisements on the hospital ward, COVID-19 special clinics.
Who may be able to join
- Age > 20 yrs
- Evidenced COVID-19 infeciton by PCR sequening or commercial IVD rapid test kits. (stratified by infection periods, before 2022 vs. in 2022)
- Clealry understand the study protocol, blood drawing, organ function survey, phenoage and phenoageAccel exams and cognitive functional evaluation.
- Agree with regular follow-up as the protocol designs
Who cannot join
- Refuse any blood draw or follow-up schedule
- Refuse at any time
- The PIs judges that the patient is no longer suitable to continue the study follow-up
- Death
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
TuCheng Hospital
New Taipei City, 236
Chia-Hsun Hsieh, Ph.D., 0975366137, wisdom5000@gmail.com
Jeng-How Yang, Ph.D., 0975366159, summerfield8731113@gmail.com
About this study
Defining the antibody response to SARS-CoV-2 will be essential for understanding disease progression, long-term immunity, and vaccine efficacy. Investigators designed a study investigating the neutralizing antibody response among post-infected and post-vaccinated individuals to determine how the spike protein neutralizing antibody correlates with natural infection and vaccination and how mutations of viral strains affect associated antibodies. New Taipei City Municipal TuCheng Hospital established a special infectious pneumonia ward in May 2021 to treat patients infected with symptomatic SARS-CoV-2 patients. During the period, 97 patients were admitted and enrolled. In light of the current timing of the pandemic, most published serological studies are predominantly cross-sectional or, at most, include a longitudinal follow-up. Cognitive function and PhenoAgeAccel will be examined for SARS-CoV-2 N and S titers decline trend analysis to correlate long-COVID brain fog or early decline of N and S antibodies.Therefore, investigators designed a three-year longitudinal study to detect patients' SARS-CoV-2 neutralizing and spike antibodies.
Read the detailed description
Coronaviruses are a diverse group of viruses infecting many different animals, and th can cause mild to severe respiratory infections in humans. At the end of 2019, a novel coronavirus designated as SARS-CoV-2 emerged in Wuhan, China, and caused an outbreak of unusual viral pneumonia. Being highly transmissible, this novel coronavirus disease, also known as coronavirus disease 2019 (COVID-19), has spread fast worldwide. It has overwhelmingly surpassed SARS and MERS regarding both the number of infected people and the spatial range of epidemic areas. The ongoing outbreak of COVID-19 has posed an extraordinary threat to global public health.
Studies in large cohorts of SARS-CoV-2 infected individuals indicate that antibodies to the receptor-binding domain (RBD) of the viral spike glycoprotein appear within the first three weeks from symptoms onset, and IgG and/or IgA seroconversion occurs either sequentially or simultaneously with the appearance of IgM. Studies showed anti-RBD IgG in 95% of COVID-19 patients by the fourth week from symptom onset and observed that these antibodies increased throughout follow-up until the third-month post-hospital discharge. Moreover, the early presence of anti-RBD IgG and anti-spike IgA positively correlated with patient survival and reduced persistence of SARS-CoV-2 RNA in nasopharyngeal swabs, respectively. The spike glycoprotein mediates entry into target cells via the ACE2 receptor. Clinical trials with monoclonal antibodies (mAbs) against its RBD decreased viral load in patients with recently diagnosed mild/moderate COVID-19.
Furthermore, anti-spike neutralizing antibodies (nAbs) produced by COVID-19 patients can block viral infection of human cells in vitro and counter viral replication in vivo. However, the impact of nAbs on the COVID-19 course is still controversial, with some studies even suggesting either a detrimental role for nAbs in disease progression or finding no nAbs differences among hospitalized patients who subsequently experienced varying disease outcomes. Whether SARS-CoV-2 nAbs decline at a similar pace is yet to be conclusively established.
Defining the antibody response to SARS-CoV-2 will be essential for understanding disease progression, long-term immunity, and vaccine efficacy. Investigators designed a study investigating the neutralizing antibody response among post-infected and post-vaccinated individuals to determine how the spike protein neutralizing antibody correlates with natural infection and vaccination and how mutations of viral strains affect associated antibodies. New Taipei City Municipal TuCheng Hospital established a special infectious pneumonia ward in May 2021 to treat patients infected with symptomatic SARS-CoV-2 patients. During the period, 97 patients were admitted and enrolled. In light of the current timing of the pandemic, most published serological studies are predominantly cross-sectional or, at most, include a longitudinal follow-up. Cognitive function and PhenoAgeAccel will be examined for SARS-CoV-2 N and S titers decline trend analysis to correlate long-COVID brain fog or early decline of N and S antibodies.
Therefore, investigators designed a three-year longitudinal study to detect participantss' SARS-CoV-2 neutralizing and spike antibodies.
- Conditions
- COVID-19
- Being tested
- Covid19 Vaccination dose
- Keywords
- SARS-CoV-2, Neutralizing antibody, Spike antibody, Cognitive function, long-COVID, Vaccine efficacy
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Covid19 Vaccination doseOther
Participants above or below 2 dose Covid19 Vaccination
| Study group | Role | What they receive |
|---|---|---|
| SARS-CoV-2 Infection | Participants from individuals with SARS-CoV-2 Infection . Receives: Other: Covid19 Vaccination dose | |
| SARS-CoV-2 non-infection with vaccination | Participants after the second dose covid19 vaccination from individuals without SARS-CoV-2 infection. Receives: Other: Covid19 Vaccination dose | |
| SARS-CoV-2 non-infection without vaccination | Participants get covid19 vaccination below 2 dose from individuals without SARS-CoV-2 infection. Receives: Other: Covid19 Vaccination dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS COVID N Ab trends among different subgroups
Participants' SARS-CoV-2 neutralizing antibody measure among different subgroups
Measured: baseline
SARS COVID N Ab trends among different subgroups
Participants' SARS-CoV-2 neutralizing antibody measure among different subgroups
Measured: 3 month
SARS COVID N Ab trends among different subgroups
Participants' SARS-CoV-2 neutralizing antibody measure among different subgroups
Measured: 6 month
SARS COVID N Ab trends among different subgroups
Participants' SARS-CoV-2 neutralizing antibody measure among different subgroups
Measured: 9 month
SARS COVID N Ab trends among different subgroups
Participants' SARS-CoV-2 neutralizing antibody measure among different subgroups
Measured: 12 month
SARS COVID S Ab trends among different subgroups
Participants' SARS-CoV-2 neutralizing antibody measure among different subgroups
Measured: baseline
SARS COVID S Ab trends among different subgroups
Participants' SARS-CoV-2 neutralizing antibody measure among different subgroups
Measured: 3 month
SARS COVID S Ab trends among different subgroups
Participants' SARS-CoV-2 neutralizing antibody measure among different subgroups
Measured: 6 month
SARS COVID S Ab trends among different subgroups
Participants' SARS-CoV-2 neutralizing antibody measure among different subgroups
Measured: 9 month
SARS COVID S Ab trends among different subgroups
Participants' SARS-CoV-2 neutralizing antibody measure among different subgroups
Measured: 12 month
Secondary outcomes (10)
SARS COVID N Ab trends among different baseline PhenoAge scores
Hematology measure associated with PhenoAge scores
Measured: baseline
SARS COVID N Ab trends among different baseline PhenoAge scores
Hematology measure associated with PhenoAge scores
Measured: 3 month
SARS COVID N Ab trends among different baseline PhenoAge scores
Hematology measure associated with PhenoAge scores
Measured: 6 month
SARS COVID N Ab trends among different baseline PhenoAge scores
Hematology measure associated with PhenoAge scores
Measured: 9 month
SARS COVID N Ab trends among different baseline PhenoAge scores
Hematology measure associated with PhenoAge scores
Measured: 12 month
SARS COVID S Ab trends among different baseline PhenoAge scores
PhenoAge scores relation physiology measure
Measured: baseline
SARS COVID S Ab trends among different baseline PhenoAge scores
Hematology measure associated with PhenoAge scores
Measured: 3 month
SARS COVID S Ab trends among different baseline PhenoAge scores
Hematology measure associated with PhenoAge scores
Measured: 6 month
SARS COVID S Ab trends among different baseline PhenoAge scores
Hematology measure associated with PhenoAge scores
Measured: 9 month
SARS COVID S Ab trends among different baseline PhenoAge scores
Hematology measure associated with PhenoAge scores
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start1 Jun 2022
- Primary completion31 Jan 2024 (estimated)
- Study completion30 Nov 2025 (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.
- More trials run by Chang Gung Memorial HospitalThe 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
- 330 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JENG-HOW YANG, Chang Gung Memorial Hospital
- Investigators
- Jeng-How Yang, Study director, Division of Infections Disease, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827939
- Sponsor's protocol ID
- CMRPVVM0151
- Status last verified
- Apr 2023
- First submitted
- 24 Apr 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Phenotypic Age and Antibody Titers Among SARS-Co-V2 Infected Patients and Vaccinated Groups
- ClinicalTrials.gov ID
- NCT05827939
- Acronym / sponsor ID
- CMRPVVM0151
- Conditions
- COVID-19
- Keywords
- SARS-CoV-2, Neutralizing antibody, Spike antibody, Cognitive function, long-COVID, Vaccine efficacy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 25 Apr 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.
Defining the antibody response to SARS-CoV-2 will be essential for understanding disease progression, long-term immunity, and vaccine efficacy. Investigators designed a study investigating the neutralizing antibody response among post-infected and post-vaccinated individuals to determine how the spike protein neutralizing antibody correlates with natural infection and vaccination and how mutations of viral strains affect associated antibodies. New Taipei City Municipal TuCheng Hospital established a special infectious pneumonia ward in May 2021 to treat patients infected with symptomatic SARS-CoV-2 patients. During the period, 97 patients were admitted and enrolled. In light of the current timing of the pandemic, most published serological studies are predominantly cross-sectional or, at most, include a longitudinal follow-up. Cognitive function and PhenoAgeAccel will be examined for SARS-CoV-2 N and S titers decline trend analysis to correlate long-COVID brain fog or early decline of N and S antibodies.Therefore, investigators designed a three-year longitudinal study to detect patients' SARS-CoV-2 neutralizing and spike antibodies.
Detailed description
Coronaviruses are a diverse group of viruses infecting many different animals, and th can cause mild to severe respiratory infections in humans. At the end of 2019, a novel coronavirus designated as SARS-CoV-2 emerged in Wuhan, China, and caused an outbreak of unusual viral pneumonia. Being highly transmissible, this novel coronavirus disease, also known as coronavirus disease 2019 (COVID-19), has spread fast worldwide. It has overwhelmingly surpassed SARS and MERS regarding both the number of infected people and the spatial range of epidemic areas. The ongoing outbreak of COVID-19 has posed an extraordinary threat to global public health.
Studies in large cohorts of SARS-CoV-2 infected individuals indicate that antibodies to the receptor-binding domain (RBD) of the viral spike glycoprotein appear within the first three weeks from symptoms onset, and IgG and/or IgA seroconversion occurs either sequentially or simultaneously with the appearance of IgM. Studies showed anti-RBD IgG in 95% of COVID-19 patients by the fourth week from symptom onset and observed that these antibodies increased throughout follow-up until the third-month post-hospital discharge. Moreover, the early presence of anti-RBD IgG and anti-spike IgA positively correlated with patient survival and reduced persistence of SARS-CoV-2 RNA in nasopharyngeal swabs, respectively. The spike glycoprotein mediates entry into target cells via the ACE2 receptor. Clinical trials with monoclonal antibodies (mAbs) against its RBD decreased viral load in patients with recently diagnosed mild/moderate COVID-19.
Furthermore, anti-spike neutralizing antibodies (nAbs) produced by COVID-19 patients can block viral infection of human cells in vitro and counter viral replication in vivo. However, the impact of nAbs on the COVID-19 course is still controversial, with some studies even suggesting either a detrimental role for nAbs in disease progression or finding no nAbs differences among hospitalized patients who subsequently experienced varying disease outcomes. Whether SARS-CoV-2 nAbs decline at a similar pace is yet to be conclusively established.
Defining the antibody response to SARS-CoV-2 will be essential for understanding disease progression, long-term immunity, and vaccine efficacy. Investigators designed a study investigating the neutralizing antibody response among post-infected and post-vaccinated individuals to determine how the spike protein neutralizing antibody correlates with natural infection and vaccination and how mutations of viral strains affect associated antibodies. New Taipei City Municipal TuCheng Hospital established a special infectious pneumonia ward in May 2021 to treat patients infected with symptomatic SARS-CoV-2 patients. During the period, 97 patients were admitted and enrolled. In light of the current timing of the pandemic, most published serological studies are predominantly cross-sectional or, at most, include a longitudinal follow-up. Cognitive function and PhenoAgeAccel will be examined for SARS-CoV-2 N and S titers decline trend analysis to correlate long-COVID brain fog or early decline of N and S antibodies.
Therefore, investigators designed a three-year longitudinal study to detect participantss' SARS-CoV-2 neutralizing and spike antibodies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV-2 Infection | – | Other: Covid19 Vaccination doseParticipants from individuals with SARS-CoV-2 Infection . |
| SARS-CoV-2 non-infection with vaccination | – | Other: Covid19 Vaccination doseParticipants after the second dose covid19 vaccination from individuals without SARS-CoV-2 infection. |
| SARS-CoV-2 non-infection without vaccination | – | Other: Covid19 Vaccination doseParticipants get covid19 vaccination below 2 dose from individuals without SARS-CoV-2 infection. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Serum samples were obtained from 3 groups of participants based on every 3-month interval. At TuCheng Hospital, infected convalescent participants were enrolled 14 days after symptom onset as the first group. Deidentified serum samples were drawn 14 days after the second dose (100-μg cohort) from participants without SARS-CoV-2 infection and post-Moderna, or AstraZeneca vaccination were enrolled as the second group. Healthy participants without SARS-CoV-2 infection were enrolled as the third group.Participants' age over 20 years old who met the enrollment criteria will be provided informed consent.These participants were prospecitvley recruited using multiple methods, including advertisements on the hospital ward, COVID-19 special clinics.
Key inclusion criteria (4 listed)
- Age > 20 yrs
- Evidenced COVID-19 infeciton by PCR sequening or commercial IVD rapid test kits. (stratified by infection periods, before 2022 vs. in 2022)
- Clealry understand the study protocol, blood drawing, organ function survey, phenoage and phenoageAccel exams and cognitive functional evaluation.
- Agree with regular follow-up as the protocol designs
Key exclusion criteria (4 listed)
- Refuse any blood draw or follow-up schedule
- Refuse at any time
- The PIs judges that the patient is no longer suitable to continue the study follow-up
- Death
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 |
|---|---|---|
| Covid19 Vaccination doseParticipants above or below 2 dose Covid19 Vaccination | Other | SARS-CoV-2 Infection, SARS-CoV-2 non-infection with vaccination, SARS-CoV-2 non-infection without vaccination |
Primary outcome
SARS COVID N Ab trends among different subgroups
Time frame: baseline
Participants' SARS-CoV-2 neutralizing antibody measure among different subgroups
SARS COVID N Ab trends among different subgroups
Time frame: 3 month
Participants' SARS-CoV-2 neutralizing antibody measure among different subgroups
SARS COVID N Ab trends among different subgroups
Time frame: 6 month
Participants' SARS-CoV-2 neutralizing antibody measure among different subgroups
SARS COVID N Ab trends among different subgroups
Time frame: 9 month
Participants' SARS-CoV-2 neutralizing antibody measure among different subgroups
SARS COVID N Ab trends among different subgroups
Time frame: 12 month
Participants' SARS-CoV-2 neutralizing antibody measure among different subgroups
SARS COVID S Ab trends among different subgroups
Time frame: baseline
Participants' SARS-CoV-2 neutralizing antibody measure among different subgroups
SARS COVID S Ab trends among different subgroups
Time frame: 3 month
Participants' SARS-CoV-2 neutralizing antibody measure among different subgroups
SARS COVID S Ab trends among different subgroups
Time frame: 6 month
Participants' SARS-CoV-2 neutralizing antibody measure among different subgroups
SARS COVID S Ab trends among different subgroups
Time frame: 9 month
Participants' SARS-CoV-2 neutralizing antibody measure among different subgroups
SARS COVID S Ab trends among different subgroups
Time frame: 12 month
Participants' SARS-CoV-2 neutralizing antibody measure among different subgroups
10 secondary outcomes
SARS COVID N Ab trends among different baseline PhenoAge scores
Time frame: baseline
SARS COVID N Ab trends among different baseline PhenoAge scores
Time frame: 3 month
SARS COVID N Ab trends among different baseline PhenoAge scores
Time frame: 6 month
SARS COVID N Ab trends among different baseline PhenoAge scores
Time frame: 9 month
SARS COVID N Ab trends among different baseline PhenoAge scores
Time frame: 12 month
SARS COVID S Ab trends among different baseline PhenoAge scores
Time frame: baseline
SARS COVID S Ab trends among different baseline PhenoAge scores
Time frame: 3 month
SARS COVID S Ab trends among different baseline PhenoAge scores
Time frame: 6 month
SARS COVID S Ab trends among different baseline PhenoAge scores
Time frame: 9 month
SARS COVID S Ab trends among different baseline PhenoAge scores
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Individual participant dataSharing planned: Undecided
Related trials for COVID-19
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
Active, not 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 recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Jeng-How Yang study director
Division of Infections Disease, Chang Gung Memorial Hospital
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 Chang Gung Memorial Hospital at 1 site in Taiwan.
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 4 inclusion and 4 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 25 Apr 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 Taiwan. 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 Chia-Hsun Hsieh, PhD (0975366137, wisdom5000@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SARS COVID N Ab trends among different subgroups (time frame: baseline). The study lists 10 primary outcomes in all. 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 25 Apr 2023.