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

March 19, 2020 updated by: Centro Studi Internazionali, Italy

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Catanzaro, Italy, 88100
        • Unità' Complesse di cure primarie (UCCP), ASP Catanzaro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days
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
30 days
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
six months
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
six months
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
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reliability of the test
Time Frame: 30 days
Number of Invalid results
30 days
Positive HCW
Time Frame: 60 days
Number of healthcare workers that become positive for COVID-19 IgM or IgG
60 days
Number of Chronic Patients
Time Frame: 60 days
Number of Chronic Patients that become positive for COVID-19 IgM or IgG
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Studi Internazionali, Italy

Collaborators

VivaChek Laboratories, Inc.

Investigators

  • Study Director: Maurizio Cipolla, MD, Medical director of UCCP CATANZARO, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2020

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

November 1, 2020

Study Registration Dates

First Submitted

March 14, 2020

First Submitted That Met QC Criteria

March 19, 2020

First Posted (Actual)

March 20, 2020

Study Record Updates

Last Update Posted (Actual)

March 20, 2020

Last Update Submitted That Met QC Criteria

March 19, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VivaDiag-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Still under development

IPD Sharing Time Frame

12 months

IPD Sharing Access Criteria

Still under development

IPD Sharing Supporting Information Type

  • Study Protocol
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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