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

NCT04393142 | Completed

• 1 other identifier: IF20-00004
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus Infection

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Identify antibodies

  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 Outcomes (3)

• Determine antibody sensitivity

  1 day

• IgM determination

  1 day

• IgG determination

  1 day

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Dr. Jose E. Gonzalez: lead

Study Sites (1)

Hospital Universitario José E. Gonzalez

Monterrey, Nuevo León, 64460, Mexico

Location

Related Publications (4)

• 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.

  PMID: 25870870 BACKGROUND

• 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.

  PMID: 32169119 BACKGROUND

• 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.

  PMID: 31986264 BACKGROUND

• 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.

  PMID: 32027631 BACKGROUND

Related Links

• "About the Virus." World Health Organization, World Health Organization, 17 Apr. 2020
• "Naming the Coronavirus Disease (COVID-19) and the Virus That Causes It." World Health Organization. World Health Organization. Accessed April 17, 2020.
• Johns Hopkins Coronavirus Resource Center." Johns Hopkins Coronavirus Resource Center. Accessed April 17, 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
• Comparative Accuracy of Oropharyngeal and Nasopharyngeal Swabs for Diagnosis of COVID-19." CEBM. Accessed April 17, 2020.
• 12\. Cdc. "Coronavirus Disease 2019 (COVID-19)." Centers for Disease Control and Prevention. Accessed April 17, 2020

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be obtained by capillary puncture or venipuncture for rapid testing of antibodies against SARS-CoV-2 (IVD COVID-19 IgM/IgG test kit, Singclean). Samples will be stored in the laboratory, and discarded at the discretion of the researcher.

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Adrian Camacho-Ortiz, MD

  Hospital Universitario "Dr. Jose Eleuterio Gonzalez, UANL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Infectious Disease Department

Study Record Dates

• First Submitted: April 26, 2020
• First Posted: May 19, 2020
• Study Start: May 5, 2020
• Primary Completion: February 16, 2021
• Study Completion: February 16, 2021
• Last Updated: February 18, 2021

Record last verified: 2021-02

Locations

ME (1)