Antibodies and Immunity After Vaccination of Recovered Pa... | NCT05484700

Studies
Antibodies and Immunity After Vaccination of Recovered Patients With COVID-19 and Long COVID-19 Symptoms

NCT05484700

Sponsor

Mahidol University

Status

Unknown status

Last Update Posted

Aug 5, 2022Actual

Enrollment

305Estimated

Phase

Not provided

Conditions

Long COVID-19

Interventions

Not provided

Countries

Thailand

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

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

Dec 30, 2021Actual

Primary Completion Date

Jul 25, 2022Actual

Completion Date

Dec 29, 2022Estimated

First Submitted Date

Aug 1, 2022

First Submission Date that Met QC Criteria

Aug 1, 2022

First Posted Date

Aug 2, 2022Actual

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

Aug 3, 2022

Last Update Posted Date

Aug 5, 2022Actual

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

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.

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

Retention

Enrollment

305Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anti-SARS-CoV-2 RBD IgG	anti-SARS-CoV-2 receptor-binding domain immunoglobulin G(BAU/mL)	Baseline
Anti-SARS-CoV-2 NP	surrogate Virus Neutralization Test (sVNT) (PRNT50 titer)	Baseline
Microneutralization assays	Microneutralization assays using the authentic SARS-CoV-2 viruses	Baseline

Secondary Outcomes

Measure	Description	Time Frame
Number of vaccine injection	Number of vaccine injection	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder 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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Korapat Mayurasakorn, MD.	Doctor in Family Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine Siriraj Hospital, Mahidol University		Bangkok Noi	Bangkok	10700	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D000094024	Post-Acute COVID-19 Syndrome

Ancestor Terms

ID	Term
D000086382	COVID-19
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections

Browse Leaves

Not provided

Browse Branches

Not provided