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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04393142

Enrollment

Registered

2020-05-19

Start date

2020-05-05

Completion date

2021-02-16

Last updated

2021-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus Infection

Keywords

COVID-19, IgM/IgG antibodies, Intradomestic contacts, IgM/IgG serological tests

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

1 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
IgM determination	1 day	Determine the presence of IgM antibodies by ELISA in direct eastern contacts of patients with detected SARS-CoV-2 PCR.
IgG determination	1 day	Determine the presence of IgG antibodies by ELISA in direct eastern contacts of patients with detected SARS-CoV-2 PCR.

Countries

Mexico

Outcome results