NCT06107348

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2023

Completed
Last Updated

October 30, 2023

Status Verified

October 1, 2023

Enrollment Period

1.5 years

First QC Date

October 26, 2023

Last Update Submit

October 26, 2023

Conditions

Immune System DiseasesCOVID-19 Vaccine Adverse ReactionImmune System Disorder

Outcome Measures

Primary Outcomes (10)

  • Chemiluminescent Immunoassay for Human Immunodeficiency Virus

    7 months

  • Carcinoembryonic Antigen

    7 months

  • Alpha Fetoprotein

    7 months

  • Carbohydrate Antigen 19-9

    7 months

  • Mucin-16

    7 months

  • Cancer Antigen 15-3

    7 months

  • Prostate-Specific Antigen

    7 months

  • Leukocytes

    7 months

  • Leukocyte Percentage

    7 months

  • Cholesterol

    7 months

Study Arms (1)

Immune Disorder

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population is currently focused on Asians.

All COVID-19 vaccinated are eligible for inclusion.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Residential Address

Chongqing, Chongqing Municipality, 402762, China

Location

Related Publications (1)

  • Pachankis YI. Questions of COVID-19: Institutional Derogations of Global Health. Lambert Academic Publishing. 2023. ISBN: 978-6206153849.

    BACKGROUND

MeSH Terms

Conditions

Immune System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDIV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

October 26, 2023

First Posted

October 30, 2023

Study Start

July 1, 2021

Primary Completion

January 4, 2023

Study Completion

December 24, 2023

Last Updated

October 30, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share
Shared Documents
CSR
Time Frame
The data will be available upon completion and will be kept for as long as the repository is available.

Available IPD Datasets

Individual Participant Data Set (10.17605/OSF.IO/2MGJK)Access

Locations

CN(1)