Plasma Immunity of Mild SARS-CoV-2 Omicron and Delta Pand... | NCT05328479

Studies
Plasma Immunity of Mild SARS-CoV-2 Omicron and Delta Pandemic in Thailand

NCT05328479

Sponsor

Mahidol University

Status

Completed

Last Update Posted

Oct 19, 2022Actual

Enrollment

5,181Actual

Phase

Not provided

Conditions

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

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 4, 2021Actual

Primary Completion Date

Mar 15, 2022Actual

Completion Date

May 20, 2022Actual

First Submitted Date

Apr 7, 2022

First Submission Date that Met QC Criteria

Apr 7, 2022

First Posted Date

Apr 14, 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

Oct 17, 2022

Last Update Posted Date

Oct 19, 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

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.

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

5,181Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anti-SARS-CoV-2 RBD IgG	Anti-RBD IgG (BAU/mL)	Baseline
Anti-SARS-CoV-2 NP	Anti-SARS-CoV-2 NP (PRNT50 titer)	Baseline
Cycle threshold of the first PCR test	Cycle threshold (Ct)	Baseline

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. people who received additional vaccination after leaving quarantine before the day of the immunization test

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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".

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
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided