Status:
COMPLETED
Validation of an Immunochromatographic Assay for IgG/IgM Antibodies to 2019- nCoV
Lead Sponsor:
European Institute of Oncology
Collaborating Sponsors:
Azienda Socio Sanitaria Territoriale di Cremona
Azienda Ospedaliera Niguarda Cà Granda
Conditions:
COVID
Eligibility:
All Genders
18+ years
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, an...
Detailed Description
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, an...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
April 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04434417
Start Date
April 15 2020
End Date
December 31 2021
Last Update
May 13 2022
Active Locations (5)
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1
Papa Giovanni XXIII Hospital
Bergamo, Italy, 24127
2
Azienda Socio-Sanitaria Territoriale di Cremona
Cremona, Italy
3
European IO, Division of Early Drug Development for Innovative Therapies
Milan, Italy, 20141
4
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Milan, Italy, 20133