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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04393142
Recruitment Status : Completed
First Posted : May 19, 2020
Last Update Posted : February 18, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. Adrian Camacho-Ortiz, Hospital Universitario Dr. Jose E. Gonzalez

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.

Condition or disease
Coronavirus Infection

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 96 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Observational Trial Evaluating the Serologic Status of Household Contacts of Patients Diagnosed With COVID-19
Actual Study Start Date : May 5, 2020
Actual Primary Completion Date : February 16, 2021
Actual Study Completion Date : February 16, 2021



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  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.

  3. 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.


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.



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04393142


Locations
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Mexico
Hospital Universitario José E. Gonzalez
Monterrey, Nuevo Leon, Mexico, 64460
Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
Investigators
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Principal Investigator: Adrian Camacho-Ortiz, MD Hospital Universitario "Dr. Jose Eleuterio Gonzalez, UANL
Additional Information:
Publications:
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Responsible Party: Dr. Adrian Camacho-Ortiz, Head of the Infectious Disease Department, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier: NCT04393142    
Other Study ID Numbers: IF20-00004
First Posted: May 19, 2020    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Adrian Camacho-Ortiz, Hospital Universitario Dr. Jose E. Gonzalez:
COVID-19
IgM/IgG antibodies
Intradomestic contacts
IgM/IgG serological tests
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases