COVID-19NCT05328479
Plasma Immunity of Mild SARS-CoV-2 Omicron and Delta Pandemic in Thailand
An observational study of COVID-19, run by Mahidol University at 1 site in Thailand.
Trial summary
The investigators assessed the effect of treatment for COVID and immunity of the volunteers who admitted to the home isolation. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- How many people
- 5,181 participants
- Where
- 1 siteThailand
- Study dates
- 4 Nov 2021to 20 May 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The COVID-19 patients who confirmed by RT-PCR at Siriraj hospital since July 8, 2021 with mild to moderate symptoms and isolated in patients' own home so-called "Siriraj Home isolation".
Who may be able to join
- patient with infected with the novel coronavirus disease 2019 (COVID-19) who has been end of self-quarantine at Siriraj Hospital more than 21 days.
- Thai nationality, able to read and write Thai language
- able to use telephone and line to communicate
Who cannot join
- 1. people who received additional vaccination after leaving quarantine before the day of the immunization test
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: The Study of Treatment Outcome and Immunogenicity of mild-to Moderate COVID-19 Patients During the Delta vs. the Omicron Pandemic
The investigators assessed the effect of treatment for COVID and immunity of the volunteers who admitted to the home isolation.
Read the detailed description
The investigators aimed to assess the effect of treatment for COVID and immunity of the volunteers who admitted to the home isolation. The investigators compared the population between the age groups 12-18 years, 18-45 years and over 45 years to monitor the symptoms of coronavirus patients treated in home isolation and long-term symptoms including factors related to the patient's recovery in the past, present, and future.
- Conditions
- COVID-19
- Keywords
- COVID-19, antibody, immunity, home isolation, vaccine
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-SARS-CoV-2 RBD IgG
Anti-RBD IgG (BAU/mL)
Measured: Baseline
Anti-SARS-CoV-2 NP
Anti-SARS-CoV-2 NP (PRNT50 titer)
Measured: Baseline
Cycle threshold of the first PCR test
Cycle threshold (Ct)
Measured: Baseline
Secondary outcomes (2)
Number of vaccine injection
Number of vaccine injection
Measured: Baseline
Type of vaccine injection
Type of vaccine injection
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start4 Nov 2021
- Primary completion15 Mar 2022
- Study completion20 May 2022
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 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
- 5,181 participants (actual)
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
- NCT05328479
- Sponsor's protocol ID
- 769/2564(IRB1)
- Status last verified
- Oct 2022
- First submitted
- 7 Apr 2022
- Last updated
- 19 Oct 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 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Treatment Outcome and Immunogenicity of mild-to Moderate COVID-19 Patients During the Delta vs. the Omicron Pandemic
- ClinicalTrials.gov ID
- NCT05328479
- Acronym / sponsor ID
- 769/2564(IRB1)
- Conditions
- COVID-19
- Keywords
- COVID-19, antibody, immunity, home isolation, vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,181 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 14 Apr 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.
The investigators assessed the effect of treatment for COVID and immunity of the volunteers who admitted to the home isolation.
Detailed description
The investigators aimed to assess the effect of treatment for COVID and immunity of the volunteers who admitted to the home isolation. The investigators compared the population between the age groups 12-18 years, 18-45 years and over 45 years to monitor the symptoms of coronavirus patients treated in home isolation and long-term symptoms including factors related to the patient's recovery in the past, present, and future.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The COVID-19 patients who confirmed by RT-PCR at Siriraj hospital since July 8, 2021 with mild to moderate symptoms and isolated in patients' own home so-called "Siriraj Home isolation".
Key inclusion criteria (3 listed)
- patient with infected with the novel coronavirus disease 2019 (COVID-19) who has been end of self-quarantine at Siriraj Hospital more than 21 days.
- Thai nationality, able to read and write Thai language
- able to use telephone and line to communicate
Key exclusion criteria (1 listed)
- 1. people who received additional vaccination after leaving quarantine before the day of the immunization test
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-RBD IgG (BAU/mL)
Anti-SARS-CoV-2 NP
Time frame: Baseline
Anti-SARS-CoV-2 NP (PRNT50 titer)
Cycle threshold of the first PCR test
Time frame: Baseline
Cycle threshold (Ct)
2 secondary outcomes
Number of vaccine injection
Time frame: Baseline
Type of vaccine injection
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
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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.
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 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 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: finished, as of the sponsor's last update on 19 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 19 Oct 2022.