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Completed

NCT Number: NCT04393142

Serologic Testing of Household Contacts of Confirmed Cases of 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.

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Key information

Conditions

Coronavirus Infection COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

1 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario José E. Gonzalez

Monterrey, Nuevo León, 64460, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Persons over 1 years of age.
  • .Meet COVID-19 confirmed case intradomestic contact definition:
  • 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.
  • 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.
  • .Informed Consent.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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 .

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 19, 2020
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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