Dynamic Evaluation of COVID-19 Diagnostic Tests (TRODVID-19)

Tourcoing Hospital

Status: Completed

Conditions: COVID-19

Treatments: Diagnostic Test: COVID-19 diagnostic test

Study type: Interventional

Funder types: Other

Identifiers

NCT04337996

RIPH_2020_6

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

experimental arm

Experimental group

Description:

These are patients whose diagnosis of SARS-Cov-2 infection was made on the Gold-Standard: combined history/clinical examination, PCR and CT scan and requiring hospitalization at Tourcoing Hospital.

Treatment:

Diagnostic Test: COVID-19 diagnostic test