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Coronavirus InfectionNCT04393142

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

An observational study of Coronavirus Infection, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 1 year and olderHealthy volunteers can take part
Conditions the study is for
Coronavirus Infection
How many people
96 participants
Where
1 siteMexico
Study dates
5 May 2020to 16 Feb 2021
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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.

Who may be able to join

  • Persons over 1 years of age.
  • .Meet COVID-19 confirmed case intradomestic contact definition:
  • 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.
  • 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.
  • .Informed Consent.

Who cannot join

  • .Have fever, cough, pharyngeal pain or clinically have symptoms compatible with COVID-19 at the time of recruitment.
  • .Autoimmune disease, cancer, neutropenia.
  • .Under 1 years of age.
  • .Patients who, in the investigator's opinion, should be excluded from the research protocol.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Hospital Universitario José E. Gonzalez

    Monterrey, Nuevo León, 64460

Other trials in Mexico

About this study

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

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.

Read the 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.

Keywords
COVID-19, IgM/IgG antibodies, Intradomestic contacts, IgM/IgG serological tests
Medical subject headings
Coronavirus Infections, COVID-19

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Identify antibodies

    Identify the presence of IgM and IgG antibodies from intradomestic contacts of patients with Polymerase Chain Reaction for detected SARS-CoV-2 .

    Measured: 1 day

Secondary outcomes (3)

  1. 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.

    Measured: 1 day

  2. IgM determination

    Determine the presence of IgM antibodies by ELISA in direct eastern contacts of patients with detected SARS-CoV-2 PCR.

    Measured: 1 day

  3. IgG determination

    Determine the presence of IgG antibodies by ELISA in direct eastern contacts of patients with detected SARS-CoV-2 PCR.

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2020
  2. Study start5 May 2020
  3. Primary completion16 Feb 2021
  4. Study completion16 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
96 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT04393142
Sponsor's protocol ID
IF20-00004
Status last verified
Feb 2021
First submitted
26 Apr 2020
Last updated
18 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 25870870

  • 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.

    PubMed 32169119

  • 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.

    PubMed 31986264

  • 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.

    PubMed 32027631

Questions about this trial

What is this clinical trial studying?

An observational study of Coronavirus Infection, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Identify antibodies (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04393142, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.

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