Association of Phenotypic Age and Antibody Titers Among SARS-Co-V2 Infected Patients and Vaccinated Groups

COVID-19 Clinical Trial

Official title:

Association of Phenotypic Age and Antibody Titers Among SARS-Co-V2 Infected Patients and Vaccinated Groups

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05827939
• Other study ID #: CMRPVVM0151
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: November 30, 2025

Study information

• Verified date: April 2023
• Source: Chang Gung Memorial Hospital
• Contact: Chia-Hsun Hsieh, PhD
• Phone: 0975366137
• Email: wisdom5000[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: November 30, 2025
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Age > 20 yrs

2. Evidenced COVID-19 infeciton by PCR sequening or commercial IVD rapid test kits. (stratified by infection periods, before 2022 vs. in 2022)

3. Clealry understand the study protocol, blood drawing, organ function survey, phenoage and phenoageAccel exams and cognitive functional evaluation.

4. Agree with regular follow-up as the protocol designs

Exclusion Criteria:

1. Refuse any blood draw or follow-up schedule

2. Refuse at any time

3. The PIs judges that the patient is no longer suitable to continue the study follow-up

4. Death

Related Conditions & MeSH terms

• COVID-19

Intervention

Other:
• Covid19 Vaccination dose
Participants above or below 2 dose Covid19 Vaccination

Locations

Country	Name	City	State
Taiwan	TuCheng Hospital	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SARS COVID N Ab trends among different subgroups	Participants' SARS-CoV-2 neutralizing antibody measure among different subgroups	baseline
Primary	SARS COVID N Ab trends among different subgroups	Participants' SARS-CoV-2 neutralizing antibody measure among different subgroups	3 month
Primary	SARS COVID N Ab trends among different subgroups	Participants' SARS-CoV-2 neutralizing antibody measure among different subgroups	6 month
Primary	SARS COVID N Ab trends among different subgroups	Participants' SARS-CoV-2 neutralizing antibody measure among different subgroups	9 month
Primary	SARS COVID N Ab trends among different subgroups	Participants' SARS-CoV-2 neutralizing antibody measure among different subgroups	12 month
Primary	SARS COVID S Ab trends among different subgroups	Participants' SARS-CoV-2 neutralizing antibody measure among different subgroups	baseline
Primary	SARS COVID S Ab trends among different subgroups	Participants' SARS-CoV-2 neutralizing antibody measure among different subgroups	3 month
Primary	SARS COVID S Ab trends among different subgroups	Participants' SARS-CoV-2 neutralizing antibody measure among different subgroups	6 month
Primary	SARS COVID S Ab trends among different subgroups	Participants' SARS-CoV-2 neutralizing antibody measure among different subgroups	9 month
Primary	SARS COVID S Ab trends among different subgroups	Participants' SARS-CoV-2 neutralizing antibody measure among different subgroups	12 month
Secondary	SARS COVID N Ab trends among different baseline PhenoAge scores	Hematology measure associated with PhenoAge scores	baseline
Secondary	SARS COVID N Ab trends among different baseline PhenoAge scores	Hematology measure associated with PhenoAge scores	3 month
Secondary	SARS COVID N Ab trends among different baseline PhenoAge scores	Hematology measure associated with PhenoAge scores	6 month
Secondary	SARS COVID N Ab trends among different baseline PhenoAge scores	Hematology measure associated with PhenoAge scores	9 month
Secondary	SARS COVID N Ab trends among different baseline PhenoAge scores	Hematology measure associated with PhenoAge scores	12 month
Secondary	SARS COVID S Ab trends among different baseline PhenoAge scores	PhenoAge scores relation physiology measure	baseline
Secondary	SARS COVID S Ab trends among different baseline PhenoAge scores	Hematology measure associated with PhenoAge scores	3 month
Secondary	SARS COVID S Ab trends among different baseline PhenoAge scores	Hematology measure associated with PhenoAge scores	6 month
Secondary	SARS COVID S Ab trends among different baseline PhenoAge scores	Hematology measure associated with PhenoAge scores	9 month
Secondary	SARS COVID S Ab trends among different baseline PhenoAge scores	Hematology measure associated with PhenoAge scores	12 month