## Protocol Section
### Identification Module
**NCT ID:** NCT05328479

**Brief Title:** Plasma Immunity of Mild SARS-CoV-2 Omicron and Delta Pandemic in Thailand

**Official Title:** The Study of Treatment Outcome and Immunogenicity of mild-to Moderate COVID-19 Patients During the Delta vs. the Omicron Pandemic

#### Organization Study ID Info
**ID:** 769/2564(IRB1)
#### Organization
**Class:** OTHER
**Full Name:** Mahidol University
### Status Module
#### Completion Date
**Date:** 2022-05-20

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-10-19

**Type:** ACTUAL

**Last Update Submit Date:** 2022-10-17

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-03-15

**Type:** ACTUAL

#### Start Date
**Date:** 2021-11-04

**Type:** ACTUAL

**Status Verified Date:** 2022-10

#### Study First Post Date
**Date:** 2022-04-14
**Type:** ACTUAL
**Study First Submit Date:** 2022-04-07
**Study First Submit QC Date:** 2022-04-07
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Mahidol University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### 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.

### Conditions Module

**Conditions:**

- COVID-19

**Keywords:**

- COVID-19

- antibody

- immunity

- home isolation

- vaccine

### Design Module

#### Bio Spec

**Description:** Plasma

**Retention:** SAMPLES_WITHOUT_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 5181

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** Anti-RBD IgG (BAU/mL)

**Measure:** Anti-SARS-CoV-2 RBD IgG

**Time Frame:** Baseline

**Description:** Anti-SARS-CoV-2 NP (PRNT50 titer)

**Measure:** Anti-SARS-CoV-2 NP

**Time Frame:** Baseline

**Description:** Cycle threshold (Ct)

**Measure:** Cycle threshold of the first PCR test

**Time Frame:** Baseline

#### Secondary Outcomes

**Description:** Number of vaccine injection

**Measure:** Number of vaccine injection

**Time Frame:** Baseline

**Description:** Type of vaccine injection

**Measure:** Type of vaccine injection

**Time Frame:** Baseline

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. 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.
2. Thai nationality, able to read and write Thai language
3. 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

**Healthy Volunteers:** True

**Minimum Age:** 12 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_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".

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bangkok Noi

**Country:** Thailand

**Facility:** Faculty of Medicine Siriraj Hospital, Mahidol University

**State:** Bangkok

**Zip:** 10700

#### Overall Officials

**Official 1:**

**Affiliation:** Doctor in Family Medicine

**Name:** Korapat Mayurasakorn, MD.

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011024

- Term: Pneumonia, Viral

- ID: D000011014

- Term: Pneumonia

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000007239

- Term: Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000018352

- Term: Coronavirus Infections

- ID: D000003333

- Term: Coronaviridae Infections

- ID: D000030341

- Term: Nidovirales Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M2561

- Name: COVID-19

- Relevance: HIGH

- As Found: COVID-19

- ID: M13904

- Name: Pneumonia

- Relevance: LOW

- As Found: Unknown

- ID: M13914

- Name: Pneumonia, Viral

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M20490

- Name: Coronavirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6555

- Name: Coronaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M23685

- Name: Nidovirales Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000086382

- Term: COVID-19

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M17360

- Name: Vaccines

- Relevance: LOW

- As Found: Unknown

- ID: M4225

- Name: Antibodies

- Relevance: LOW

- As Found: Unknown

- ID: M10184

- Name: Immunoglobulins

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
