Immune System DiseasesNCT06107348
COVID-19 Post-Vaccination Observation
An observational study of Immune System Diseases and COVID-19 Vaccine Adverse Reaction, run by Yang I. Pachankis, PhD at 1 site in China.
Trial summary
The study started after the second COVID-19 vaccination of the participant with blood spots appearing on the skin with severe arthritis. The study continued to the third-dose full vaccination of the participant with the recombined COVID-19 vaccination and afterwards. The study completed until intervention. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune System Diseases, COVID-19 Vaccine Adverse Reaction, Immune System Disorder
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 24 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population is currently focused on Asians.
All COVID-19 vaccinated are eligible for inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COVID-19 Post-Vaccination Observation on Immune Exhaustion
The study started after the second COVID-19 vaccination of the participant with blood spots appearing on the skin with severe arthritis. The study continued to the third-dose full vaccination of the participant with the recombined COVID-19 vaccination and afterwards. The study completed until intervention.
- Medical subject headings
- Immune System Diseases
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 |
|---|---|---|
| Immune Disorder | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chemiluminescent Immunoassay for Human Immunodeficiency Virus
Measured: 7 months
Carcinoembryonic Antigen
Measured: 7 months
Alpha Fetoprotein
Measured: 7 months
Carbohydrate Antigen 19-9
Measured: 7 months
Mucin-16
Measured: 7 months
Cancer Antigen 15-3
Measured: 7 months
Prostate-Specific Antigen
Measured: 7 months
Leukocytes
Measured: 7 months
Leukocyte Percentage
Measured: 7 months
Cholesterol
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start1 Jul 2021
- Primary completion4 Jan 2023
- Study completion24 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immune System DiseasesStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yang I. Pachankis, PhD
- Responsible party
- Sponsor-investigator, Yang I. Pachankis, PhD, Pachankis, Yang I., M.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107348
- Sponsor's protocol ID
- SARS-Immune-00
- Status last verified
- Oct 2023
- First submitted
- 26 Oct 2023
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Pachankis YI. Questions of COVID-19: Institutional Derogations of Global Health. Lambert Academic Publishing. 2023. ISBN: 978-6206153849.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Post-Vaccination Observation on Immune Exhaustion
- ClinicalTrials.gov ID
- NCT06107348
- Acronym / sponsor ID
- SARS-Immune-00
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Yang I. Pachankis, PhD
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 4 Jan 2023 (actual)
- Study completion
- 24 Dec 2023 (estimated)
- First posted
- 30 Oct 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.
The study started after the second COVID-19 vaccination of the participant with blood spots appearing on the skin with severe arthritis. The study continued to the third-dose full vaccination of the participant with the recombined COVID-19 vaccination and afterwards. The study completed until intervention.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immune Disorder | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is currently focused on Asians.
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
Chemiluminescent Immunoassay for Human Immunodeficiency Virus
Time frame: 7 months
Carcinoembryonic Antigen
Time frame: 7 months
Alpha Fetoprotein
Time frame: 7 months
Carbohydrate Antigen 19-9
Time frame: 7 months
Mucin-16
Time frame: 7 months
Cancer Antigen 15-3
Time frame: 7 months
Prostate-Specific Antigen
Time frame: 7 months
Leukocytes
Time frame: 7 months
Leukocyte Percentage
Time frame: 7 months
Cholesterol
Time frame: 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- BackgroundPachankis YI. Questions of COVID-19: Institutional Derogations of Global Health. Lambert Academic Publishing. 2023. ISBN: 978-6206153849.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Immune System Diseases and COVID-19 Vaccine Adverse Reaction, run by Yang I. Pachankis, PhD 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?
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 30 Oct 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?
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?
Chemiluminescent Immunoassay for Human Immunodeficiency Virus (time frame: 7 months). 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?
On the ClinicalTrials.gov record for NCT06107348, which also lists 1 linked publication.
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 30 Oct 2023.