Long COVID-19NCT05484700
Antibodies and Immunity After Vaccination of Recovered Patients With COVID-19 and Long COVID-19 Symptoms
An observational study of Long COVID-19, run by Mahidol University at 1 site in Thailand.
Trial summary
We investigated the association between immune system responsibilities in Long COVID patients and Full recovery patients. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Long COVID-19
- How many people
- 305 participants
- Where
- 1 siteThailand
- Study dates
- 30 Dec 2021to 29 Dec 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The COVID-19 patients who confirmed SARS-CoV-2 infection from January to May 2022 (during the Omicron wave), and post COVID-19 they had not received any additional COVID vaccine.
Who may be able to join
- Long COVID group; at longer than 1-month post COVID-19 based the presence of one of the three following symptoms: fatigue/myalgia, breathlessness, and anorexia
- Full recovery group; patients with asymptomatic symptoms
- post COVID-19 they had not received any additional COVID vaccine
Who cannot join
- people who received additional vaccination after leaving quarantine before the day of the immunization test
- pregnant patients,
- people who had a history of allergic reactions after COVID-19 vaccination or any drugs
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok Noi, Bangkok, 10700
About this study
Official title: SARS-CoV-2 Neutralizing Antibodies and Immunity After Vaccination of Recovered Patients With COVID-19 and Correlation With Immunity and Long-COVID-19 Symptoms
We investigated the association between immune system responsibilities in Long COVID patients and Full recovery patients.
Read the detailed description
This retrospective cohort study compared immunogenicity post COVID-19 between individuals (aged 18-65 years and had confirmed SARS-CoV-2 infection from January to May 2022 ) with residual Long COVID-19 symptoms (LC) and ones with full recovery (Full) related to pathophysiology, immunology and clinical consequence.
- Conditions
- Long COVID-19
- Keywords
- Long COVID-19, antibody responsibility, immunogenicity
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-SARS-CoV-2 RBD IgG
anti-SARS-CoV-2 receptor-binding domain immunoglobulin G(BAU/mL)
Measured: Baseline
Anti-SARS-CoV-2 NP
surrogate Virus Neutralization Test (sVNT) (PRNT50 titer)
Measured: Baseline
Microneutralization assays
Microneutralization assays using the authentic SARS-CoV-2 viruses
Measured: Baseline
Secondary outcomes (2)
Number of vaccine injection
Number of vaccine injection
Measured: Baseline
Prevalence of Long COVID-19 symptoms
Number of participants with major Long COVID-19 symptoms including fatigue/myalgia, breathlessness, and anorexia by using the questionnaire
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start30 Dec 2021
- Primary completion25 Jul 2022
- Study completion29 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVID-19Studies of the same condition, open and under way.
- More trials run by Mahidol 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
- Retrospective
- Enrolment
- 305 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Korapat Mayurasakorn, MD., Principal investigator, Doctor in Family Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484700
- Sponsor's protocol ID
- 1013/2564(IRB3)
- Status last verified
- Aug 2022
- First submitted
- 1 Aug 2022
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-CoV-2 Neutralizing Antibodies and Immunity After Vaccination of Recovered Patients With COVID-19 and Correlation With Immunity and Long-COVID-19 Symptoms
- ClinicalTrials.gov ID
- NCT05484700
- Acronym / sponsor ID
- 1013/2564(IRB3)
- Conditions
- Long COVID-19
- Keywords
- Long COVID-19, antibody responsibility, immunogenicity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 305 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 30 Dec 2021 (actual)
- Primary completion
- 25 Jul 2022 (actual)
- Study completion
- 29 Dec 2022 (estimated)
- First posted
- 2 Aug 2022 (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.
We investigated the association between immune system responsibilities in Long COVID patients and Full recovery patients.
Detailed description
This retrospective cohort study compared immunogenicity post COVID-19 between individuals (aged 18-65 years and had confirmed SARS-CoV-2 infection from January to May 2022 ) with residual Long COVID-19 symptoms (LC) and ones with full recovery (Full) related to pathophysiology, immunology and clinical consequence.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The COVID-19 patients who confirmed SARS-CoV-2 infection from January to May 2022 (during the Omicron wave), and post COVID-19 they had not received any additional COVID vaccine.
Key inclusion criteria (3 listed)
- Long COVID group; at longer than 1-month post COVID-19 based the presence of one of the three following symptoms: fatigue/myalgia, breathlessness, and anorexia
- Full recovery group; patients with asymptomatic symptoms
- post COVID-19 they had not received any additional COVID vaccine
Key exclusion criteria (3 listed)
- people who received additional vaccination after leaving quarantine before the day of the immunization test
- pregnant patients,
- people who had a history of allergic reactions after COVID-19 vaccination or any drugs
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
Anti-SARS-CoV-2 RBD IgG
Time frame: Baseline
anti-SARS-CoV-2 receptor-binding domain immunoglobulin G(BAU/mL)
Anti-SARS-CoV-2 NP
Time frame: Baseline
surrogate Virus Neutralization Test (sVNT) (PRNT50 titer)
Microneutralization assays
Time frame: Baseline
Microneutralization assays using the authentic SARS-CoV-2 viruses
2 secondary outcomes
Number of vaccine injection
Time frame: Baseline
Prevalence of Long COVID-19 symptoms
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
Related trials for Long 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)
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Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
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.
Korapat Mayurasakorn, MD. principal investigator
Doctor in Family Medicine
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 Long COVID-19, run by Mahidol University at 1 site in Thailand.
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 5 Aug 2022. 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 Thailand. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-SARS-CoV-2 RBD IgG (time frame: Baseline). The study lists 3 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 5 Aug 2022.