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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04316728
Recruitment Status : Not yet recruiting
First Posted : March 20, 2020
Last Update Posted : March 20, 2020
Sponsor:
Collaborator:
VivaChek Laboratories, Inc.
Information provided by (Responsible Party):
Centro Studi Internazionali, Italy

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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 Outcome Measures :
  1. Reliability of the test [ Time Frame: 30 days ]
    Number of Invalid results

  2. Positive HCW [ Time Frame: 60 days ]
    Number of healthcare workers that become positive for COVID-19 IgM or IgG

  3. Number of Chronic Patients [ Time Frame: 60 days ]
    Number of Chronic Patients that become positive for COVID-19 IgM or IgG



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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%)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04316728


Contacts
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Contact: Antonio V Gaddi, MD, MSc +393920039246 antonio.gaddi@ehealth.study
Contact: Fabio V Capello, MD, PhD fabio.capello@ehealth.study

Locations
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Italy
Unità' Complesse di cure primarie (UCCP), ASP Catanzaro
Catanzaro, Italy, 88100
Contact: Maurizio Cipolla, MD       maurizio.cipolla@ehealth.study   
Sponsors and Collaborators
Centro Studi Internazionali, Italy
VivaChek Laboratories, Inc.
Investigators
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Study Director: Maurizio Cipolla, MD Medical director of UCCP CATANZARO, Italy
Publications:

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Responsible Party: Centro Studi Internazionali, Italy
ClinicalTrials.gov Identifier: NCT04316728    
Other Study ID Numbers: VivaDiag-2020
First Posted: March 20, 2020    Key Record Dates
Last Update Posted: March 20, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Still under development
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: 12 months
Access Criteria: Still under development

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centro Studi Internazionali, Italy:
COVID-19
IgM Test
IgG Test
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases