Contagiousness and Immunogenicity Status of COVID-19 in Asymptomatic Population (COVID-19 CONDITION)

NCT04389658 | Completed

• 1 other identifier: IGX1-COV-XS-20-01
• Study Type: observational
• Target: 1,526
• Locations: 1 country
• Sites: 1

Brief Summary

In late December 2019, a new coronavirus strain emerged in China causing coronavirus disease 2019 (COVID-19). Since then, COVID-19 has become a global pandemic outbreak being declared a "public health emergency of international concern" by the International Health Regulations Emergency Committee of the WHO on January 30, 2020. Several emergency measures have been implemented in different countries such as lockdown, social distancing and testing. However, due to the lack of tests worldwide the real number of affected and/or immunized people remains largely unknown. In this moment, when reopening phases are being undertaken in the majority of countries, the decision to enact any of these measures rests with the judgement of each health care system. However, every country or individual community circumstances may be unique and require contextual consideration based on the severity and time of the pandemic as well as the number of resources available. The present study aims to retrospectively describe the immune and infective spectrum of illness from Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection in the general asymptomatic population in three main areas of Spain (Madrid, Barcelona and Valencia) with high impact of COVID-19, right after the lockdown period.

Conditions

COVID-19

Keywords

SARS-CoV-2; Severe acute respiratory syndrome coronavirus 2; COVID-19

Outcome Measures

Primary Outcomes (2)

• Prevalence of contagiousness in asymptomatic individuals by PCR

  This outcome measure statistically quantifies the Prevalence of contagiousness in asymptomatic individuals based on the gold standard test (PCR). These results will be analysed in order to focus on the best combination to detect the presence of the disease and the immunological stage in this population at the three main areas of Spain (Madrid, Barcelona and Valencia) with high impact of COVID-19.

  2 months

• Ratio of asymptomatic immunized (IgA/IgM and IgG) population

  This outcome measure statistically quantifies the rate of immunized (IgA/IgM and IgG) individuals based on the ELISA test. These results will be analysed in order to focus on the best combination to detect the presence of the disease and the immunological stage in this population at the three main areas of Spain (Madrid, Barcelona and Valencia) with high impact of COVID-19.

  2 months

Secondary Outcomes (1)

• Description of demographic characteristics

  2 months

Study Arms (1)

Asymptomatic population

Subjects who underwent PCR and ELISA tests for the diagnosis of COVID-19: mainly asymptomatic individuals from three main areas of Spain (Madrid, Barcelona and Valencia) with high impact of COVID-19 that have performed the PCR and ELISA test for the diagnosis of COVID-19 before initiating the work immediately after Spanish lockdown.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Anonymized data produced by Igenomix from previous PCR and ELISA tests of mainly asymptomatic individuals will be used in this study. Approximately, 1,000 cases will be assessed.

You may qualify if:

• Mainly asymptomatic individuals from different corporations of urban areas of Barcelona, Madrid and Valencia that have performed the test before initiating the work immediately after Spanish lockdown from the end of April until beginning of May.

Sponsors & Collaborators

• Igenomix: lead

Study Sites (1)

Igenomix

Paterna, Valencia, 46980, Spain

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Xavier Santamaria, MD,PhD

  Igenomix

  PRINCIPAL INVESTIGATOR

• Carlos Simon, MD,PhD

  Igenomix

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 15, 2020
• Study Start: May 7, 2020
• Primary Completion: June 10, 2020
• Study Completion: August 25, 2020
• Last Updated: October 9, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)