NCT05328479

Brief Summary

The investigators assessed the effect of treatment for COVID and immunity of the volunteers who admitted to the home isolation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5,181

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

November 4, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 14, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2022

Completed
Last Updated

October 19, 2022

Status Verified

October 1, 2022

Enrollment Period

4 months

First QC Date

April 7, 2022

Last Update Submit

October 17, 2022

Conditions

Keywords

COVID-19antibodyimmunityhome isolationvaccine

Outcome Measures

Primary Outcomes (3)

  • 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 (2)

  • Number of vaccine injection

    Baseline

  • Type of vaccine injection

    Baseline

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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".

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok Noi, Bangkok, 10700, Thailand

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Korapat Mayurasakorn, MD.

    Doctor in Family Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2022

First Posted

April 14, 2022

Study Start

November 4, 2021

Primary Completion

March 15, 2022

Study Completion

May 20, 2022

Last Updated

October 19, 2022

Record last verified: 2022-10

Locations