Clinical trial NCT04393142: Serologic Testing of Household Contacts of Confirmed Cases of COVID-19
Official title: Observational Trial Evaluating the Serologic Status of Household Contacts of Patients Diagnosed With COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus Infection
Keywords: COVID-19
IgM/IgG antibodies
Intradomestic contacts
IgM/IgG serological tests
Lead sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 96
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Identify antibodies
timeFrame: 1 day
Secondary outcomes:
measure: Determine antibody sensitivity
timeFrame: 1 day
measure: IgM determination
timeFrame: 1 day
measure: IgG determination
timeFrame: 1 day
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Hospital Universitario José E. Gonzalez
state: Nuevo Leon
Study officials:
affiliation: Hospital Universitario "Dr. Jose Eleuterio Gonzalez, UANL
name: Adrian Camacho-Ortiz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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.
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.