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

Long COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05484700
• Other study ID #: 1013/2564(IRB3)
• Status: Active, not recruiting
• Start date: December 30, 2021
• Est. completion date: December 29, 2022

Study information

• Verified date: August 2022
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 305
• Est. completion date: December 29, 2022
• Est. primary completion date: July 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Long COVID-19

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok Noi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-SARS-CoV-2 RBD IgG	anti-SARS-CoV-2 receptor-binding domain immunoglobulin G(BAU/mL)	Baseline
Primary	Anti-SARS-CoV-2 NP	surrogate Virus Neutralization Test (sVNT) (PRNT50 titer)	Baseline
Primary	Microneutralization assays	Microneutralization assays using the authentic SARS-CoV-2 viruses	Baseline
Secondary	Number of vaccine injection	Number of vaccine injection	Baseline
Secondary	Prevalence of Long COVID-19 symptoms	Number of participants with major Long COVID-19 symptoms including fatigue/myalgia, breathlessness, and anorexia by using the questionnaire	Baseline