Clinical Performance of the VivaDiag ™ COVID-19 lgM / IgG Rapid Test in Early Detecting the Infection of COVID-19

Sponsor

Centro Studi Internazionali, Italy (Other)

Overall Status

Unknown status

CT.gov ID

NCT04316728

Collaborator

VivaChek Laboratories, Inc. (Other)

200

Enrollment

Location

Arm

Anticipated Duration (Months)

24.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronavirus Infections	Device: VivaDiag™ COVID-19 lgM/IgG Rapid Test	N/A

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)

take out the test kit and leave it at least 30 minutes in the room where the test will be performed.
place the test equipment on a clean and dust-free surface
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.
read the result after 15 minutes

Interpretation of test results

Positive result

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.
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.
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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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

Anticipated Study Start Date :

Mar 1, 2020

Anticipated Primary Completion Date :

Sep 1, 2020

Anticipated Study Completion Date :

Nov 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: negative Patients Adult HCWs with no signs or symptom of coronavirus infection and no known previous history of contact with patients positive for COVID-19, working in a primary care setting and Adult patients with at least 2 chronic medical conditions routinely attending a General Practioner (GP) practice or an outpatients departments or a primary care facility	Device: VivaDiag™ COVID-19 lgM/IgG Rapid Test VivaDiag™ COVID-19 lgM/IgG Rapid Test is an in vitro diagnostic for the qualitative determination of COVID-19 IgM and IgG antibodies in human whole blood (from vein or fingertip), serum or plasma

Arm

Intervention/Treatment

Other: negative Patients

Adult HCWs with no signs or symptom of coronavirus infection and no known previous history of contact with patients positive for COVID-19, working in a primary care setting and Adult patients with at least 2 chronic medical conditions routinely attending a General Practioner (GP) practice or an outpatients departments or a primary care facility

Device: VivaDiag™ COVID-19 lgM/IgG Rapid Test

VivaDiag™ COVID-19 lgM/IgG Rapid Test is an in vitro diagnostic for the qualitative determination of COVID-19 IgM and IgG antibodies in human whole blood (from vein or fingertip), serum or plasma

Outcome Measures

Primary Outcome Measures

Number of patients with constant negative results [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 [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 [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 [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 [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 Outcome Measures

Reliability of the test [30 days]
Number of Invalid results
Positive HCW [60 days]
Number of healthcare workers that become positive for COVID-19 IgM or IgG
Number of Chronic Patients [60 days]
Number of Chronic Patients that become positive for COVID-19 IgM or IgG

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

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%)