Clinical trial NCT04316728: Clinical Performance of the VivaDiag ™ COVID-19 lgM / IgG Rapid Test in Early Detecting the Infection of COVID-19
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronavirus Infections
Keywords: COVID-19
IgM Test
IgG Test
Lead sponsor: Centro Studi Internazionali, Italy
Sponsor class: NETWORK
Collaborators: name: VivaChek Laboratories, Inc.
First posted: 2020-03-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Procedure (as per the protocol in use for the administration of the test)

1. take out the test kit and leave it at least 30 minutes in the room where the test will be performed.
2. place the test equipment on a clean and dust-free surface
3. First insert 10µL of whole blood or serum or plasma in the area reserved for blood (in the well) present on the test, then apply 2 drops of buffer.
4. read the result after 15 minutes

Interpretation of test results

Positive result

1. The anti-COVID-19 lgM antibody is detected if: the quality control band C and the lgM band are both colored and the lgG band does not stain. This means that the anti-COVID-19 lgM antibody is positive.
2. The anti-COVID-19 lgG antibody is detected if: the quality control band C and the lgG band are both colored and the lgM band does not stain. This means that the COVID-19 lgG antibody is positive.
3. The lgG and lgM anti-COVID-19 antibodies are detected if: the C band, the lgG band and the lgM band are all three colored. This means that the anti-COVID-19 lgG and lgM antibodies are both positive.

Negative result The anti-COVID-19 lgG and lgM antibodies are not detected if only the quality control C band is stained but the lgG and lgM bands are not colored, this means that the test is negative.

Invalid result

If the quality control band C does not color, regardless of whether the lgG and lgM bands are colored or not, the result is invalid and the test must be started again.

Specs of the test

Product Name VivaDiag™ COVID-19 IgM/IgG Rapid Test Test Principle Colloidal gold Sample Type Whole blood (from vein or fingertip), serum or plasma Sample Volume 10 μL Test Time 15 min Operation Temperature 18-25ºC Storage Temperature 2-30ºC Shelf Life (Unopened) 12 months

Eligibility criteria: 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%)

Primary outcomes:
measure: Number of patients with constant negative results
timeFrame: 30 days
measure: Number of patients with positive test with a positive PCR for COVID-19
timeFrame: 30 days
measure: Overall Number of patients positive for COVID-19
timeFrame: six months
measure: Overall Number of patients negative for COVID-19
timeFrame: six months
measure: Number of patients with contrasting results
timeFrame: 30 days
Secondary outcomes:
measure: Reliability of the test
timeFrame: 30 days
measure: Positive HCW
timeFrame: 60 days
measure: Number of Chronic Patients
timeFrame: 60 days
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: Unità' Complesse di cure primarie (UCCP), ASP Catanzaro
Study officials:
affiliation: Medical director of UCCP CATANZARO, Italy
name: Maurizio Cipolla, MD
role: STUDY_DIRECTOR
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