Validation of an Immunochromatographic Assay for IgG/IgM Antibodies to 2019- nCoV

NCT04434417 | Completed

• 1 other identifier: I-GLOBAL
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 5

Brief Summary

In COVID-19 pandemic, it is of critical importance to identify a rapid and simple diagnostic method to be used in clinical settings to timely inform and refine strategies that can prevent, control, and stop the spread of SARS-CoV-2. The 2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative, membrane-based immunoassay for the detection of immunoglobulin G (IgG) and Immunoglobulin M (IgM) antibodies to SARS-CoV-2 in whole blood, serum or plasma specimen. Clinical specimens from patients who were suspected of being infected with 2019-nCoV will be used to evaluate the performance of the assay.

Conditions

COVID

Keywords

immunoassay; immunoglobulin IgM; immunoglobulin IgG; cancer; COVID

Outcome Measures

Primary Outcomes (7)

• Evaluation of the rate of SARS-CoV-2 positive cancer patients and health professionals in a comprehensive cancer center or in a cancer setting.

  Patients positive are serially tested with SARSCoV-2 lgM / IgG Rapid Test to evaluate the immune response in IgG negative patients and the reliability of the test in those patients who develop clinical signs of SARS-CoV-2 during the trial.

  6 months

• Evaluation of test accuracy

  The 2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) was compared with a leading commercial Polymerase Chain Reaction

  3 months

• Interleukin-6 quantification

  Multiplex immunoassay

  3 months

• Interleukin-2 quantification

  Multiplex immunoassay

  3 months

• Interleukin-1 quantification

  Multiplex immunoassay

  6 months

• Tumor Necrosis Factor (TNF) quantification

  Multiplex immunoassay

  3 months

• Interferon gamma quantification

  Multiplex immunoassay

  3 months

Study Arms (1)

Cohort tested

The cohort will include patients or health professionals who patients who were suspected of being infected with 2019-nCoV

Device: 2019-nCoV IgG/IgM Rapid Test Cassette

Interventions

2019-nCoV IgG/IgM Rapid Test Cassette DEVICE

The specimen (whole blood, serum, plasma) will be loaded into the cassette and will migrate via capillary action along the membrane to react with the gold conjugate. The result will be available in 10 minutes

Cohort tested

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population includes: * Patients or health professionals already tested positive for the viral RNA from nasopharyngeal swabs by RT-PCR * Patients or health professional who are suspected of being infected with SARS-CoV-2 in the hospital * Patients who are considered at high risk for infection and eligible for active therapy and major surgery.

You may qualify if:

• Suspected cases who meet the following 2 criteria at the same time:
• Epidemiological history: There was a history of contact with confirmed cases before the onset of illness; or subjects with at least one symptom in the last week before accrual in the trial. Subjects who have been in contact with people positive for SARS-CoV-2 in the previous 14 days.
• Clinical manifestations are defined as :
• Fever \>37.5°; dry cough, muscle pain and/or fatigue, anosmia, subjects with respiratory distress (Respiratory Rate \>25/min or O2 Saturation \<92%) or imaging characteristics of pneumonia; or the total number of white blood cells is normal or decreased with the lymphocyte count decreased in the early stage of onset or there is an abnormal C-Reactive protein. Other symptoms that clinical investigator will relate to SARS-CoV-2 infection. Subject or cancer patients who have been quarantined for suspect symptoms and have access to hospital to continue therapy or to receive major surgery
• Confirmed cases, namely patients or subjects with positive Reverse Transcription-Polymerase Chain Reaction (RT-PCR) for SARS-CoV-2. On the basis of meeting the criteria for suspected cases, sputum, throat swabs, lower respiratory tract secretions, and other specimens are tested by realtime RT-PCR for positive nucleic acid detection of new coronavirus; or viral gene sequencing is highly homologous with known new coronaviruses. Patients positive are serially tested with SARS-CoV-2 lgM / IgG Rapid Test to evaluate the immune response in IgG negative patients and the reliability of the test in those patients who develop clinical signs of SARS-CoV-2 during the trial.
• Patients who are considered at high risk for infection and eligible for active therapy and major surgery
• Frailty (age and multiple comorbidities) planned to receive a standard systemic anticancer treatment comprising chemotherapy and/or immunotherapy and/or radiation therapy or to receive an experimental treatment
• Major surgery or surgery after neoadjuvant chemotherapy and or chemo/radiotherapy

You may not qualify if:

• Ascertained influenza virus, parainfluenza virus, adenovirus, respiratory syncytial virus, rhinovirus, human metapneumovirus, Severe Acute Respiratory Syndrome coronavirus, and other known other viral pneumonia;
• Ascertained mycoplasma pneumoniae, chlamydia pneumonia, and bacterial pneumonia; non-infectious diseases such as vasculitis, dermatomyositis, and organizing pneumonia.

Sponsors & Collaborators

• European Institute of Oncology: lead
• Azienda Socio Sanitaria Territoriale di Cremona: collaborator
• Azienda Ospedaliera Niguarda Cà Granda: collaborator
• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta: collaborator
• Papa Giovanni XXIII Hospital: collaborator

Study Sites (5)

Papa Giovanni XXIII Hospital

Bergamo, 24127, Italy

Location

Azienda Socio-Sanitaria Territoriale di Cremona

Cremona, Italy

Location

European IO, Division of Early Drug Development for Innovative Therapies

Milan, 20141, Italy

Location

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Milan, 20133, Italy

Location

Azienda Ospedaliera Niguarda Cà Granda

Milan, 20162, Italy

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Giuseppe Curigliano, MD

  European IO

  PRINCIPAL INVESTIGATOR

• Antonio Marra, MD

  European IO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 16, 2020
• Study Start: April 15, 2020
• Primary Completion: July 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 13, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: At the end of the study
• Access Criteria: Upon request

Locations

IT (5)