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

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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

Tracking Information
First Submitted Date April 26, 2020
First Posted Date May 19, 2020
Last Update Posted Date February 18, 2021
Actual Study Start Date May 5, 2020
Actual Primary Completion Date February 16, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 10, 2020)
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 .
Original Primary Outcome Measures
 (submitted: May 15, 2020)
Identify antibodies [ Time Frame: 1 day ]
Identify the presence of IgM and IgG antibodies from intradomestic contacts of patients with PCR for detected SARS-CoV-2 .
Change History
Current Secondary Outcome Measures
 (submitted: May 15, 2020)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration 1 Day
Biospecimen Retention:   Samples With DNA
Description:

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.

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.

Condition Coronavirus Infection
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 16, 2021)
96
Original Estimated Enrollment
 (submitted: May 15, 2020)
92
Actual Study Completion Date February 16, 2021
Actual Primary Completion Date February 16, 2021   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Year and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Mexico
Removed Location Countries  
 
Administrative Information
NCT Number NCT04393142
Other Study ID Numbers IF20-00004
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Dr. Adrian Camacho-Ortiz, Hospital Universitario Dr. Jose E. Gonzalez
Study Sponsor Hospital Universitario Dr. Jose E. Gonzalez
Collaborators Not Provided
Investigators
Principal Investigator: Adrian Camacho-Ortiz, MD Hospital Universitario "Dr. Jose Eleuterio Gonzalez, UANL
PRS Account Hospital Universitario Dr. Jose E. Gonzalez
Verification Date February 2021