Clinical Performance of the VivaDiag ™ COVID-19 lgM / IgG Rapid Test in a Cohort of Negative Patients for Coronavirus Infection for the Early Detection of Positive Antibodies for COVID-19
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Number of patients with constant negative results
Study Overview
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 response in negative patients and the reliability of the test in those patients who develop clinical signs of COVID-19 during the trial.
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 VivaDiag ™ COVID-19 lgM / IgG Rapid Test at day 0, day 7 and day 14. The investigators expect test to be negative on all the measurements in those patients that do not develop symptoms and that continue to have no known history of exposure to COVID-19
Patients that develop symptoms (cough, fever or respiratory distress) and a possible contact with people positive for COVID-19 OR patients that show a positive VivaDiag test during the time frame of the test are asked to attend the COVID-19 RT - PCR &CT.
Subsequently, the investigators will continue, repeating two tests seven days apart every 30 days (predefined times 0-7-14, then 30-37, 60-67) for the next six months. The investigators can evaluate to stop the test however before the six months if there are no new cases of COVID-19 for at least 21 days in the region where the enrolled patients live.
The test in use is the VivaDiag ™ COVID-19 lgM / IgG
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Adults healthcare workers (HCW) OR
- •Chronic patients with at least 2 chronic medical conditions
Exclusion Criteria
- •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%)
Outcomes
Primary Outcomes
Number of patients with constant negative results
Time Frame: 30 days
Number of patients with negative results in the three measurements, compared to the number of patients with at least one positive test
Number of patients with positive test with a positive PCR for COVID-19
Time Frame: 30 days
Number of patients that present at least one positive VivaDiag test that when subsequently tested with PCR remain positive
Overall Number of patients positive for COVID-19
Time Frame: six months
Where available, number of patients positive for COVID-19 IgG and IgM and positive for COVID-19 PCR
Overall Number of patients negative for COVID-19
Time Frame: six months
Where available, number of patients negative for COVID-19 IgG and IgM and negative for COVID-19 PCR
Number of patients with contrasting results
Time Frame: 30 days
Where available, number of patients positive for COVID-19 IgG and IgM and negative for COVID-19 PCR, or negative for COVID-19 IgG and IgM and positive for COVID-19 PCR
Secondary Outcomes
- Reliability of the test(30 days)
- Positive HCW(60 days)
- Number of Chronic Patients(60 days)