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

NCT04316728 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-03-20

No results posted yet for this study

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.

Conditions

  • Coronavirus Infections

Interventions

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

Sponsors & Collaborators

  • VivaChek Laboratories, Inc.

    collaborator UNKNOWN

  • Centro Studi Internazionali, Italy

    lead NETWORK

Principal Investigators

  • Maurizio Cipolla, MD · Medical director of UCCP CATANZARO, Italy

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-31
Primary Completion
2020-09-30
Completion
2020-11-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04316728 on ClinicalTrials.gov