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

Coronavirus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04393142
• Other study ID #: IF20-00004
• Status: Completed
• Start date: May 5, 2020
• Est. completion date: February 16, 2021

Study information

• Verified date: February 2021
• Source: Hospital Universitario Dr. Jose E. Gonzalez
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: February 16, 2021
• Est. primary completion date: February 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• Severe Acute Respiratory Syndrome

Locations

Country	Name	City	State
Mexico	Hospital Universitario José E. Gonzalez	Monterrey	Nuevo Leon

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Dr. Jose E. Gonzalez

Country where clinical trial is conducted

Mexico, 

References & Publications (4)

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. Review. — View Citation

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. Erratum in: Lancet. 2020 Jan 30;:. — View Citation

Maier HJ, Bickerton E, Britton P. Preface. Coronaviruses. Methods Mol Biol. 2015;1282:v. — View Citation

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. Erratum in: MMWR Morb Mortal Wkly Rep. 2020 Feb 14;69(6):173. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Determine antibody sensitivity	Determine the sensitivity of IgM and IgG antibody detection by ELISA in direct eastern contacts of patients with PCR for detected SARS-CoV-2.	1 day
Secondary	IgM determination	Determine the presence of IgM antibodies by ELISA in direct eastern contacts of patients with detected SARS-CoV-2 PCR.	1 day
Secondary	IgG determination	Determine the presence of IgG antibodies by ELISA in direct eastern contacts of patients with detected SARS-CoV-2 PCR.	1 day

External 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.
•   12. Cdc. "Coronavirus Disease 2019 (COVID-19)." Centers for Disease Control and Prevention. 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.
•   Johns Hopkins Coronavirus Resource Center." Johns Hopkins Coronavirus Resource Center. Accessed April 17, 2020.
•   Lipsitch, Marc, J. Grein, Y. Zhang, N. van Doremalen, and Center for Communicable Disease Dynamics. "Defining the Epidemiology of Covid-19 - Studies Needed: NEJM." New England Journal of Medicine, April 10, 2020