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

Overview

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.

Full Title of Study: “Observational Trial Evaluating the Serologic Status of Household Contacts of Patients Diagnosed With COVID-19″

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: June 13, 2020

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.

Clinical Trial Outcome Measures

Primary Measures

  • Identify antibodies
    • Time Frame: 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 Measures

  • Determine antibody sensitivity
    • Time Frame: 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
    • Time Frame: 1 day
    • Determine the presence of IgM antibodies by ELISA in direct eastern contacts of patients with detected SARS-CoV-2 PCR.
  • IgG determination
    • Time Frame: 1 day
    • Determine the presence of IgG antibodies by ELISA in direct eastern contacts of patients with detected SARS-CoV-2 PCR.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 1 Year

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Hospital Universitario Dr. Jose E. Gonzalez
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. Adrian Camacho-Ortiz, Head of the Infectious Disease Department – Hospital Universitario Dr. Jose E. Gonzalez
  • Overall Official(s)
    • Adrian Camacho-Ortiz, MD, Principal Investigator, Hospital Universitario “Dr. Jose Eleuterio Gonzalez, UANL
  • Overall Contact(s)
    • Edurdo Pérez Alba, MD, +52 8117998705, md.eduardo.perez@gmail.com

References

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

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.

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;:.

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.