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

Coronavirus Infections Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04316728
• Other study ID #: VivaDiag-2020
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2020
• Est. completion date: November 2020

Study information

• Verified date: March 2020
• Source: Centro Studi Internazionali, Italy
• Contact: Antonio V Gaddi, MD, MSc
• Phone: +393920039246
• Email: antonio.gaddi[@]ehealth.study
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: November 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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%)

Related Conditions & MeSH terms

• Communicable Diseases
• Coronavirus Infections
• Infection
• Severe Acute Respiratory Syndrome

Intervention

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

Locations

Country	Name	City	State
Italy	Unità' Complesse di cure primarie (UCCP), ASP Catanzaro	Catanzaro

Sponsors (2)

Lead Sponsor	Collaborator
Centro Studi Internazionali, Italy	VivaChek Laboratories, Inc.

Country where clinical trial is conducted

Italy, 

References & Publications (20)

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Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Feb 28. doi: 10.1056/NEJMoa2002032. [Epub ahead of print] — View Citation

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* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with constant negative results	Number of patients with negative results in the three measurements, compared to the number of patients with at least one positive test	30 days
Primary	Number of patients with positive test with a positive PCR for COVID-19	Number of patients that present at least one positive VivaDiag test that when subsequently tested with PCR remain positive	30 days
Primary	Overall Number of patients positive for COVID-19	Where available, number of patients positive for COVID-19 IgG and IgM and positive for COVID-19 PCR	six months
Primary	Overall Number of patients negative for COVID-19	Where available, number of patients negative for COVID-19 IgG and IgM and negative for COVID-19 PCR	six months
Primary	Number of patients with contrasting results	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	Reliability of the test	Number of Invalid results	30 days
Secondary	Positive HCW	Number of healthcare workers that become positive for COVID-19 IgM or IgG	60 days
Secondary	Number of Chronic Patients	Number of Chronic Patients that become positive for COVID-19 IgM or IgG	60 days