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Completed

NCT Number: NCT04337996

Dynamic Evaluation of COVID-19 Diagnostic Tests

Rapid antigenic tests are not yet used in real life. Their contribution in the diagnostic strategy based on the gold standard including anamnesis, thoracic CT and PCR has not been evaluated.

We propose to compare to the Gold-Standard defined above, the combination of an SARS-Cov-2 antigen, anamnesis and thoracic CT for the diagnosis of COVID-19 infection.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Tourcoing

Tourcoing, 59208, France

About this study

This is an interventional study comparing gold standard anamnesis, thoracic CT and PCR versus SARS-Cov-2 antigen, anamnesis and thoracic CT for the diagnosis of COVID-19 infection.

Patients will be sampled for the tests at Day 1 and then monitored for symptoms and clinical data and additional test at Day 21.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Symptomatic patient with confirmed Gold-Standard SARS-CoV-2 (COVID-19) infection
  • Presenting at least one criterion for hospitalization:
  • Respiratory failure and oxygenation
  • Circulatory failure (systolic BP < 90 mmHg)
  • Neurological failure (confusion, drowsiness, altered consciousness)
  • Polypathological terrain and co-morbidities (chronic respiratory failure, heart failure or cardiovascular pathology, renal failure, diabetes, immunosuppression, obesity, cirrhosis)
  • Eligible for different sampling methods
  • Beneficiary of a social insurance scheme or entitled person

Exclusion criteria

  • Gold Standard not in favour of SARS-Cov-2 infection (COVID 19)
  • Minor patient
  • Refusal to participate
  • Patient under guardianship
  • Patient under guardianship
  • Pregnant or breastfeeding woman

Treatment and study plan

COVID-19 diagnostic test

Diagnostic Test

COVID-19 diagnostic tests performed at day 1 (antigen in blood serum, SARS-Cov2 PCR, antibodies in blood serum) COVID-19 diagnostic test performed at day 21 (antibodies in blood serum)

Primary outcomes

  1. Comparison of the proportion of patients classified as COVID-19 positive according to the 2 strategies

    Time frame: day 1

    Comparison of the Gold-Standard PCR, anamnesis, thoracic CT scan versus SARS-Cov-2 antigen, anamnesis and thoracic CT scan

Secondary outcomes

  1. Positive or negative Covid-19 test

    Time frame: day 1

    Number of diagnoses invalidated by the antigen + CT scan alone without the contribution of PCR.

  2. Positive or negative character of the antibodies test

    Time frame: day 1

    Comparison of the proportion of patients with positive serology for SARS-Cov2 to the proportion of patients who were classified as COVID-19

  3. Positive or negative character of the antibodies test

    Time frame: day 21

    Comparison of the proportion of patients with positive serology for SARS-Cov2 to the proportion of patients who were classified as COVID-19 at the time of hospitalization

  4. Biological parameters

    Time frame: day 1

    Evolution of biological parameters as a function of time IgM IgA and IgG

  5. Biological parameters

    Time frame: Day 21

    Evolution of biological parameters as a function of time IgM IgA and IgG

  6. medical-economic comparison

    Time frame: day 1

    medical-economic comparison of the first-line use of the antigenic test

Sponsors and collaborators

Lead sponsor

Tourcoing Hospital

Other

Registry information

Acronym: TRODVID-19

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 8, 2020
Registry last updated
Jan 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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