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

NCT ID: NCT04393142

Last Updated: 2021-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

96 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-05

Study Completion Date

2021-02-16

Brief Summary

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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

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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.

Conditions

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Coronavirus Infection

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Universitario Dr. Jose E. Gonzalez

OTHER

Sponsor Role lead

Responsible Party

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Dr. Adrian Camacho-Ortiz

Head of the Infectious Disease Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adrian Camacho-Ortiz, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario "Dr. Jose Eleuterio Gonzalez, UANL

Locations

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Hospital Universitario José E. Gonzalez

Monterrey, Nuevo León, Mexico

Site Status

Countries

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Mexico

References

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Maier HJ, Bickerton E, Britton P. Preface. Coronaviruses. Methods Mol Biol. 2015;1282:v. doi: 10.1007/978-1-4939-2438-7. No abstract available.

Reference Type BACKGROUND
PMID: 25870870 (View on PubMed)

Guo YR, Cao QD, Hong ZS, Tan YY, Chen SD, Jin HJ, Tan KS, Wang DY, Yan Y. The origin, transmission and clinical therapies on coronavirus disease 2019 (COVID-19) outbreak - an update on the status. Mil Med Res. 2020 Mar 13;7(1):11. doi: 10.1186/s40779-020-00240-0.

Reference Type BACKGROUND
PMID: 32169119 (View on PubMed)

Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.

Reference Type BACKGROUND
PMID: 31986264 (View on PubMed)

Patel A, Jernigan DB; 2019-nCoV CDC Response Team. Initial Public Health Response and Interim Clinical Guidance for the 2019 Novel Coronavirus Outbreak - United States, December 31, 2019-February 4, 2020. MMWR Morb Mortal Wkly Rep. 2020 Feb 7;69(5):140-146. doi: 10.15585/mmwr.mm6905e1.

Reference Type BACKGROUND
PMID: 32027631 (View on PubMed)

Related Links

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http://www.euro.who.int/en/health-topics/health-emergencies/coronavirus-covid-19/novel-coronavirus-2019-ncov

"About the Virus." World Health Organization, World Health Organization, 17 Apr. 2020

https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/naming-the-coronavirus-disease-(covid-2019)-and-the-virus-that-causes-it

"Naming the Coronavirus Disease (COVID-19) and the Virus That Causes It." World Health Organization. World Health Organization. Accessed April 17, 2020.

https://coronavirus.jhu.edu/map.html.

Johns Hopkins Coronavirus Resource Center." Johns Hopkins Coronavirus Resource Center. Accessed April 17, 2020.

https://www.who.int/es/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---11-march-2020

Alocución de apertura del Director General de la OMS en la rueda de prensa sobre la COVID-19 celebrada el 11 de marzo de 2020". Organización Mundial de la Salud. Organización Mundial de la Salud. Accedido el 17 de abril de 2020

https://www.cebm.net/covid-19/comparative-accuracy-of-oropharyngeal-and-nasopharyngeal-swabs-for-diagnosis-of-covid-19/.

Comparative Accuracy of Oropharyngeal and Nasopharyngeal Swabs for Diagnosis of COVID-19." CEBM. Accessed April 17, 2020.

https://www.coronavirus.gov/.

12\. Cdc. "Coronavirus Disease 2019 (COVID-19)." Centers for Disease Control and Prevention. Accessed April 17, 2020

Other Identifiers

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IF20-00004

Identifier Type: -

Identifier Source: org_study_id

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