NCT05484700

Brief Summary

We investigated the association between immune system responsibilities in Long COVID patients and Full recovery patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
305

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

December 30, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2022

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 1, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2022

Completed
Last Updated

August 5, 2022

Status Verified

August 1, 2022

Enrollment Period

7 months

First QC Date

August 1, 2022

Last Update Submit

August 3, 2022

Conditions

Keywords

Long COVID-19antibody responsibilityimmunogenicity

Outcome Measures

Primary Outcomes (3)

  • 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 (2)

  • Number of vaccine injection

    Baseline

  • Prevalence of Long COVID-19 symptoms

    Baseline

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

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 WITH DNA

Plasma Serum

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

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

August 1, 2022

First Posted

August 2, 2022

Study Start

December 30, 2021

Primary Completion

July 25, 2022

Study Completion

December 29, 2022

Last Updated

August 5, 2022

Record last verified: 2022-08

Locations