Clinical Trials Logo
  1. Home
  2. Covid19
  3. NCT05096962
  4. Details
NCT05096962 Clinical Trial

COVID-19: SARS-CoV-2-CZ-PREVAL-II Study

COVID-19 Clinical Trial

Official title:
SARS-CoV-2-CZ-PREVAL-II Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05096962
Other study ID # 2021/2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 13, 2021
Est. completion date February 24, 2022

Study information
Verified date October 2021
Source Institute of Health Information and Statistics of the Czech Republic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of the SARS-CoV-2-CZ-PREVAL-II Study is to quantify the prevalence of participants with antibodies against SARS-CoV-2 and/or cell immunity against SARS-CoV-2 in specific subjects cohorts.

Description:

The aim of the SARS-CoV-2-CZ-PREVAL-II Study is to quantify the prevalence of participants with antibodies against SARS-CoV-2 and/or cell immunity against SARS-CoV-2 in four specific cohorts: participants with chronic illness, healthy volunteers participating in the Study of the Czech Academy of Science, healthcare workers, and healthy volunteers that participated in the "Herd Immunity Study SARS-CoV-2-CZ-Preval" in May 2020. The primary aim of the study is to estimate the number of people with anti-SARS-CoV-2-antibodies, i.e., people with COVID-19 history, or with vaccination against COVID-19. Antibodies test will focus on two main proteins of virus SARS-CoV-2: S-protein and N-protein. The secondary aims of the study are: - quantitative analysis of cellular immunity and the other relevant markers, - estimation of the proportion of participants with asymptomatic COVID-19 infection - quantification of anti-SARS-CoV-2 antibodies and cell immunity according to individual risk factors.

Recruitment information / eligibility
Status Completed
Enrollment 7268
Est. completion date February 24, 2022
Est. primary completion date October 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - signed Informed consent - willingness to complete the study questionnaire - demographic criteria - age 18 years old and more - clinical criteria - without acute health problems - time criteria - sample collection in the defined period time Exclusion Criteria: - none

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Quantitative analysis of SARS-CoV-2 antibodies
The study will evaluate the current presence of infection, specific antibodies at least in the IgG class in blood plasma or serum (antibody tests focusing on two SARS-CoV-2 proteins: S-protein and N-protein).
• Cellular immunity
Quantification of the level of cellular immunity from venous blood collected in approximately 30% of examined individuals.

Locations
Country Name City State
Czechia Institute of Health Information and Statistics of the Czech Republic Prague

Sponsors (9)
Lead Sponsor Collaborator
Institute of Health Information and Statistics of the Czech Republic Czech Academy of Sciences, Institute for Clinical and Experimental Medicine, Ministry of Health, Czech Republic, Palacky University, The Institute of Molecular and Translational Medicine, Czech Republic, The National Institute of Public Health, Thomayer University Hospital, University Hospital Olomouc

Country where clinical trial is conducted

Czechia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Detection of a number of subjects with IgG anti-SARS-CoV-2 antibodies The primary outcome is to quantify the prevalence of participants with IgG anti-SARS-CoV-2 antibodies in the specified subjects cohorts. September-October 2021
See also
  Status Clinical Trial Phase
Recruiting NCT06065033 - Exercise Interventions in Post-acute Sequelae of Covid-19 N/A
Completed NCT06267534 - Mindfulness-based Mobile Applications Program N/A
Completed NCT05047601 - A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection Phase 2/Phase 3
Recruiting NCT05323760 - Functional Capacity in Patients Post Mild COVID-19 N/A
Recruiting NCT04481633 - Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection N/A
Completed NCT04537949 - A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults Phase 1/Phase 2
Completed NCT04612972 - Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru Phase 3
Recruiting NCT05494424 - Cognitive Rehabilitation in Post-COVID-19 Condition N/A
Active, not recruiting NCT06039449 - A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2 Phase 3
Enrolling by invitation NCT05589376 - You and Me Healthy
Completed NCT05158816 - Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
Recruiting NCT04341506 - Non-contact ECG Sensor System for COVID19
Completed NCT04384445 - Zofin (Organicell Flow) for Patients With COVID-19 Phase 1/Phase 2
Completed NCT04512079 - FREEDOM COVID-19 Anticoagulation Strategy Phase 4
Active, not recruiting NCT05975060 - A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants. Phase 2/Phase 3
Active, not recruiting NCT05542862 - Booster Study of SpikoGen COVID-19 Vaccine Phase 3
Withdrawn NCT05621967 - Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation N/A
Terminated NCT05487040 - A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease Phase 1
Terminated NCT04498273 - COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80 Phase 3
Active, not recruiting NCT06033560 - The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure