Serologic Testing of Household Contacts of Confirmed Cases of COVID-19

February 16, 2021 updated by: Dr. Adrian Camacho-Ortiz, Hospital Universitario Dr. Jose E. Gonzalez

Observational Trial Evaluating the Serologic Status of Household Contacts of Patients Diagnosed With COVID-19

SARS-CoV-2 has now crossed the 1 million number of cases and tens of thousands of deaths. It´s R0 has been calculated between 2 and 5.7 solely based on clinical symptoms but it is estimated to likely be higher. Serologic evidence of infection has not been analyzed.

Study Overview

Status

Completed

Conditions

Detailed Description

Transverse, observational and descriptive study involving household contacts of documented patients with COVID-19 infection: contacts will be invited to participate and a blood sample will be drowned: IgM and IgG qualitative and quantitative measurements will be performed. Demographic data regarding age, comorbidities, calculated time spent before and after the patients diagnosis, isolation practices etc.

Study Type

Observational

Enrollment (Actual)

96

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

  • Mexico
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
        • Hospital Universitario José E. Gonzalez

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

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The intradomiciliary contacts of the patients with a detected SARS-CoV-2 PCR test (nasopharyngeal and / or oropharyngeal swab) performed at the Acute Respiratory Infection Diagnosis Unit between March 2020 and May 2020 will be located: will invite to participate in the study to record their clinical and demographic data and to take serological samples by venipuncture or fingerstick to perform rapid tests for antibodies against SARS-CoV-2 (IVD COVID-19 IgM / IgG test kit, Singclean).

Informed consent shall be obtained from each person for the collection of samples. The data collected will be captured in an electronic database in Excel.

Description

Inclusion Criteria:

  1. Persons over 1 years of age.

  2. .Meet COVID-19 confirmed case intradomestic contact definition:

    1. Living in the same home as the patient with SARS-CoV-2 PCR test detected (nasopharyngeal and/or oropharyngeal swab) performed in the Acute Respiratory Infection Diagnostic Unit.
    2. Living in the same home as the patient with a PCR test for SARS-CoV-2 Indeterminate (nasopharyngeal and/or oropharyngeal swab) performed in the Acute Respiratory Infection Diagnostic Unit and that the initial patient has positive IgM/IgG serology for SARS-CoV-2.
  3. .Informed Consent.

Exclusion Criteria:

  1. .Have fever, cough, pharyngeal pain or clinically have symptoms compatible with COVID-19 at the time of recruitment.
  2. .Autoimmune disease, cancer, neutropenia.
  3. .Under 1 years of age.
  4. .Patients who, in the investigator's opinion, should be excluded from the research protocol.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify antibodies
Time Frame: 1 day
Identify the presence of IgM and IgG antibodies from intradomestic contacts of patients with Polymerase Chain Reaction for detected SARS-CoV-2 .
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine antibody sensitivity
Time Frame: 1 day
Determine the sensitivity of IgM and IgG antibody detection by ELISA in direct eastern contacts of patients with PCR for detected SARS-CoV-2.
1 day
IgM determination
Time Frame: 1 day
Determine the presence of IgM antibodies by ELISA in direct eastern contacts of patients with detected SARS-CoV-2 PCR.
1 day
IgG determination
Time Frame: 1 day
Determine the presence of IgG antibodies by ELISA in direct eastern contacts of patients with detected SARS-CoV-2 PCR.
1 day

Collaborators and Investigators

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

Sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Investigators

  • Principal Investigator: Adrian Camacho-Ortiz, MD, Hospital Universitario "Dr. Jose Eleuterio Gonzalez, UANL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

May 5, 2020

Primary Completion (Actual)

February 16, 2021

Study Completion (Actual)

February 16, 2021

Study Registration Dates

First Submitted

April 26, 2020

First Submitted That Met QC Criteria

May 15, 2020

First Posted (Actual)

May 19, 2020

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IF20-00004

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.

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