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COVID-19 Contact Study by Antigen Detection Test (DETAC)

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ClinicalTrials.gov Identifier: NCT04745533
Recruitment Status : Not yet recruiting
First Posted : February 9, 2021
Last Update Posted : February 11, 2021
Sponsor:
Information provided by (Responsible Party):
Juan Fernando Masa Jiménez, University of Extremadura

Study Description
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Brief Summary:

Stopping the SARS-CoV2 spread is essential to control the pandemic cause by this virus.

A great effort is being made to carry out surveillance, case detection and contact control protocols in order to detect and isolate those contagious subjects.

Since both symptomatic and asymptomatic subjects can be contagious, a surveillance system based on the presence of symptoms is not enough, requiring to perform diagnostic tests in a large number of subjects, such as asymptomatic contacts or high-prevalence populations, and repeatedly. Moreover, the speed in obtaining results is crucial in order not to delay the isolations of positive subjects.

The polymerase chain reaction (PCR) is an expensive test which requires specialized equipment and personnel with a delay in results of 24-48 hours. In addition, its high sensitivity can mean that subjects without infective capacity have a positive result.

In contrast, antigen detection tests (ADTs) are cheap and easy to perform, having a result in few minutes. They have shown high sensitivity and specificity in symptomatic subjects, specially in the first week of symptoms when the viral load is high. This could be very useful for the study of asymptomatic contacts to detect those with potential contagiousness quick, easily and cheaply. However, there is no evidence to support the use of ADTs in this group of subjects.

For this reason, the investigators propose to carry out a study to compare the diagnostic efficacy of ADTs versus PCR in the group of subjects considered to be close contacts of SARS-Cov2 positive patients in the health area of Cáceres.


Condition or disease Intervention/treatment
SARS-CoV Infection Diagnostic Test: Antigen detection test

Study Design
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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnostic Efficacy of the SARS-CoV2 Antigen Detection Test for the COVID-19 Contact Study
Estimated Study Start Date : February 15, 2021
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
SARS-CoV2 contacts
Subjects considered close contacts of COVID-19 patients according to the definition of the Ministry of Health in the health area of Cáceres.
 Diagnostic Test: Antigen detection test
To compare the results of the antigen detection test against the polymerase chain reaction in the study of contacts of COVID-19 patients during quarantine.


Outcome Measures
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Primary Outcome Measures :
  1. Sensitivity of the antigen detection test used in the study of contacts of COVID-19 patients. [ Time Frame: 2 days ]
    The investigators will analyze the probability of a positive antigen detection test result in a COVID-19 patient contact with a positive polymerase chain reaction test.

  2. Specificity of the antigen detection test used in the study of contacts of COVID-19 patients. [ Time Frame: 2 days ]
    The investigators will analyze the probability of a negative antigen detection test result in a COVID-19 patient contact with a negative polymerase chain reaction test.


Secondary Outcome Measures :
  1. Positive predictive value of the antigen detection test used in the study of contacts of COVID-19 patients. [ Time Frame: 2 days ]
    The investigators will analyze the probability that a subject considered COVID-19 patient contact with a positive antigen detection test result has a positive polymerase chain reaction test.

  2. Negative predictive value of the antigen detection test used in the study of contacts of COVID-19 patients. [ Time Frame: 2 days ]
    The investigators will analyze the probability that a subject considered COVID-19 patient contact with a negative antigen detection test result has a negative polymerase chain reaction test.

  3. Positive likelihood ratio of the antigen detection test used in the study of contacts of COVID-19 patients. [ Time Frame: 2 days ]
    The investigators will analyze how much the probability of having a positive polymerase chain reaction test increases when a subject considered a COVID-19 patient contact has a positive antigen detection test.

  4. Negative likelihood ratio of the antigen detection test used in the study of contacts of COVID-19 patients. [ Time Frame: 2 days ]
    The investigators will analyze how much the probability of having a positive polymerase chain reaction test decreases when a subject considered a COVID-19 patient contact has a negative antigen detection test.

  5. Change in the pretest probability when the antigen detection test result is positive in a COVID-19 patient contact. [ Time Frame: 2 days ]
    The investigators will analyze the change that occurs in the probability that a subject considered a COVID-19 contact has a positive polymerase chain reaction test before and after performing an antigen detection test with a positive result

  6. Change in the pretest probability when the antigen detection test result is negative in a COVID-19 patient contact. [ Time Frame: 2 days ]
    The investigators will analyze the change that occurs in the probability that a subject considered a COVID-19 contact has a positive polymerase chain reaction test before and after performing an antigen detection test with a negative result

  7. Cut-off point of the cycle threshold of the polymerase chain reaction test that discriminates infectivity. [ Time Frame: 2 weeks ]
    The investigators will analyze the cut-off point of polymerase chain reaction test (PCR) cycle threshold that maximizes discrimination of patients with at least one close contact with positive PCR (infectivity in the first circle of contacts).

  8. Risk of SARS-CoV2 infection in close contacts of COVID-19 patients with a positive polymerase chain reaction test depending on whether the antigen detection test is positive or negative. [ Time Frame: 2 weeks ]
    The investigators will compare the number of infected subjects by COVID-19 patient contacts with a positive polymerase chain reaction test, depending on whether the antigen detection test is positive or negative

  9. To predict a positive result of the polymerase chain reaction test based on the appearance of symptoms during quarantine [ Time Frame: 10 days ]
    Researchers will analyze the appearance of symptoms during quarantine in the contacts of COVID-19 patients and whether or not they have a positive polymerase chain reaction test.

  10. The percentage of COVID-19 patient contacts with symptoms during the quarantine. [ Time Frame: 10 days ]
    The investigators analyze the percentage of contacts of COVID-19 patients who develop symptoms during the quarantine.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All subjects considered close contacts of COVID-19 patients according to the definition of the Ministry of Health of Spain in the health area of Cáceres
Criteria

Inclusion Criteria:

  • Subjects considered close contacts of COVID-19 patients according to the definition of the Ministry of Health of Spain at the time of inclusion.

Exclusion Criteria:

  • Subjects who do not obtain their informed consent for the study.
  • Symptomatic subject at the time of inclusion.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Juan Fernando Masa Jiménez, Principal investigator, University of Extremadura
ClinicalTrials.gov Identifier: NCT04745533    
Other Study ID Numbers: 12/2020
First Posted: February 9, 2021    Key Record Dates
Last Update Posted: February 11, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Additional related documents such as study protocol, statistical analysis plan and informed consent form will be available upon request from the project principal investigator.

(Dr. Juan Fernando Masa Jiménez). De-identified patients´data can be requested by researchers for use in independent scientific research and will provided following review and approval of the research proposal (including statistical analysis plan) and completion of a data sharing agreement with the Project Publications Committee. Investigator Data requests can be made anytime from 1 to 2 years after the publication of this trial. Requests should be sent to the corresponding author (Dr. Juan Fernando Masa Jiménez- fmasa@separ.es)

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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 Juan Fernando Masa Jiménez, University of Extremadura:
Antigen detection tests
Diagnostic efficacy
Contact study
Asymptomatic contacts
Additional relevant MeSH terms:
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Severe Acute Respiratory Syndrome
Respiratory Tract Infections
Infections
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases