COVID-19 Post-Vaccination Observation | NCT06107348

Studies
COVID-19 Post-Vaccination Observation

NCT06107348

Sponsor

Yang I. Pachankis, PhD

Status

Unknown status

Last Update Posted

Oct 30, 2023Actual

Enrollment

1Actual

Phase

Not provided

Conditions

Immune System Diseases
COVID-19 Vaccine Adverse Reaction
Immune System Disorder

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2021Actual

Primary Completion Date

Jan 4, 2023Actual

Completion Date

Dec 24, 2023Estimated

First Submitted Date

Oct 26, 2023

First Submission Date that Met QC Criteria

Oct 26, 2023

First Posted Date

Oct 30, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2023

Last Update Posted Date

Oct 30, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Label	Type	Description	Intervention Names
Immune Disorder

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

All COVID-19 vaccinated are eligible for inclusion.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

The study population is currently focused on Asians.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Residential Address		Chongqing	Chongqing Municipality	402762	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	Pachankis YI. Questions of COVID-19: Institutional Derogations of Global Health. Lambert Academic Publishing. 2023. ISBN: 978-6206153849.

Type	Date	Date Unknown
Release	Oct 28, 2023
Reset	Jun 7, 2024
Release	Jul 19, 2024
Reset	Oct 31, 2024

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Oct 28, 2023			Jun 7, 2024
Jul 19, 2024