Status:
UNKNOWN
Clinical Performance of the VivaDiag ™ COVID-19 lgM / IgG Rapid Test in Early Detecting the Infection of COVID-19
Lead Sponsor:
Centro Studi Internazionali, Italy
Collaborating Sponsors:
VivaChek Laboratories, Inc.
Conditions:
Coronavirus Infections
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study aim to evaluate the immune response of negative patients during a COVID-19 outbreak. Patients are serially tested with a VivaDiag ™ COVID-19 lgM / IgG Rapid Test to evaluate the immune res...
Detailed Description
This study aim to evaluate the immune response of negative patients during a COVID-19 outbreak in patients with no symptoms and with no known exposure to the COVID-19. Patients are tested with a Viva...
Eligibility Criteria
Inclusion
- Adults healthcare workers (HCW) OR
- Chronic patients with at least 2 chronic medical conditions
Exclusion
- People that have been in contact with people positive for COVID-19 in the previous 14 days
- People with body temperature \>37.5°C
- People with Dry cough
- People with Respiratory distress (Respiratory Rate \>25/min or O2 Saturation \<92%)
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2020
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04316728
Start Date
March 1 2020
End Date
November 1 2020
Last Update
March 20 2020
Active Locations (1)
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1
Unità' Complesse di cure primarie (UCCP), ASP Catanzaro
Catanzaro, Italy, 88100