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

Completed

• Conditions: Coronavirus Infection

• Registration Number: NCT04393142
• Lead Sponsor: Hospital Universitario Dr. Jose E. Gonzalez

Brief Summary

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.

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 Timeline

• Study First Submitted: 2020-04-26
• Study Start: 2020-05-05
• Study First Submitted QC: 2020-05-15
• Study First Posted: 2020-05-19
• Status Verified: 2021-02
• Primary Completion: 2021-02-16
• Study Completion: 2021-02-16
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identify antibodies	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 Outcome Measures

Name	Time	Method
IgM determination	1 day	Determine the presence of IgM antibodies by ELISA in direct eastern contacts of patients with detected SARS-CoV-2 PCR.
Determine antibody sensitivity	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.
IgG determination	1 day	Determine the presence of IgG antibodies by ELISA in direct eastern contacts of patients with detected SARS-CoV-2 PCR.

Trial Locations

Locations (1)

Hospital Universitario José E. Gonzalez; 🇲🇽 Monterrey, Nuevo Leon, Mexico