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

August 3, 2022 updated by: Mahidol University

SARS-CoV-2 Neutralizing Antibodies and Immunity After Vaccination of Recovered Patients With COVID-19 and Correlation With Immunity and Long-COVID-19 Symptoms

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

Study Overview

Status

Active, not recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

305

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Bangkok Noi, Bangkok, Thailand, 10700
        • Faculty of Medicine Siriraj Hospital, Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of vaccine injection
Time Frame: Baseline
Number of vaccine injection
Baseline
Prevalence of Long COVID-19 symptoms
Time Frame: Baseline
Number of participants with major Long COVID-19 symptoms including fatigue/myalgia, breathlessness, and anorexia by using the questionnaire
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 30, 2021

Primary Completion (Actual)

July 25, 2022

Study Completion (Anticipated)

December 29, 2022

Study Registration Dates

First Submitted

August 1, 2022

First Submitted That Met QC Criteria

August 1, 2022

First Posted (Actual)

August 2, 2022

Study Record Updates

Last Update Posted (Actual)

August 5, 2022

Last Update Submitted That Met QC Criteria

August 3, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1013/2564(IRB3)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Long COVID-19

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe