Correlative Study on Cancer Patients and Healthcare Professionals Exposed to Infection by Severe Acute Respiratory Syndrome-Corona Virus-2 (SARS-Cov-2), COVID-19 Causative Agent.

COVID-19 Clinical Trial

— CORSA  

Official title:

Correlative Study on Cancer Patients and Healthcare Professionals Exposed to SARS-CoV-2 Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04345315
• Other study ID #: IRSTB113
• Status: Recruiting
• Start date: March 27, 2020
• Est. completion date: March 2022

Study information

• Verified date: April 2020
• Source: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
• Contact: Giovanni Martinelli, Prof
• Phone: +39 0543 739100
• Email: giovanni.martinelli[@]irst.emr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Translational, prospective / retrospective, non-profit, non-pharmacological study, with cohort characteristics.

The study consists of two parts: the first to study epidemiological aspects of the spread of the disease and the second one to identify infection-related genetic factors.

Description:

The outbreak of COVID-19 infections is spreading in Italy with unprecedented severity characteristics. In this context, it is essential to collect data relating to the epidemiology of the disease, to outline further useful tools for diagnosis and to define the correct use of rapid molecular and / or serological tests in the surveillance of high-risk subjects (cancer patients and healthcare operators), in order to identify any new disease control strategies, crucial to reduce the transmission and to outline specific guidelines for cancer patients healthcare management. It is also necessary to identify the factors that determine the evolution of the viral genome over time in the various geographical areas and also the potential susceptibility markers in the different types of affected subjects (symptomatic, mildly symptomatic and asymptomatic).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 2022
• Est. primary completion date: March 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

For epidemiologic analysis:

Inclusion Criteria:

• Age > 18 years

• asymptomatic

• One of the following three conditions: • Healthy subjects who have had contact with COVID-19 positive patients • Healthcare workers • oncological patients candidates for cytotoxic chemotherapy at myeloablative doses (such as transplants) or treated with immune-check point inhibitors.

• informed consent to the study and processing of data

Exclusion Criteria:

• presence of symptoms for COronaVIrus Disease 19 (COVID-19) (fever > 37.5 °, cough, shortness of breath)

For analysis of viral/host genetic factors involved in susceptibility/resistance to infection, samples from patients with confirmed diagnosis of COVID-19, residual from diagnostic procedures will be analyzed. All samples for genetic analysis will be anonymized.

Related Conditions & MeSH terms

• COVID-19
• Infection
• SARS-CoV-2

Intervention

Other:
• serological test
serological test assessing IgM and IgG directed against SARS-CoV-2
• Rapid molecular test
Molecular test to detect SARS-CoV-2 in oro/rhinopharyngeal swab

Genetic:
• Next generation Sequencing (NGS) analysis
analysis of genetic variability of virus and host

Other:
• serum chemistry analysis
Analysis of serum chemistry factors and coagulation panel in blood samples

Locations

Country	Name	City	State
Italy	UO Microbiologia,Centro Servizi Pievesestina, AUSL Romagna	Cesena	FC
Italy	Irst Irccs	Meldola	FC

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori	AUSL Romagna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	epidemiology	Investigate the epidemiology of the infection in an asymptomatic population including both healthy individuals at high risk of infection and oncological patients by assessing the seroprevalence of IgG and IgM antibodies against the SARS-CoV-2	12 months
Secondary	Immunoglobulin G (IgG) and Immunoglobulin M (IgM) antibodies evaluation	IgG and IgM antibodies evaluation over time	12 months
Secondary	methods comparison	Make a comparison between different serological investigation methods and rapid molecular methods becoming available	24 months
Secondary	correlation between biochemical and coagulative factors with SARS-CoV-2 positivity.	To evaluate correlation between biochemical and coagulative factors with SARS-CoV-2 positivity	24 months
Secondary	phylogenetic map	Building a phylogenetic map of an epidemic Italian macro-region	24 months
Secondary	interactions between the virus and host cells	Evaluate the spectrum of possible interactions between the virus and host cells, considering their genetic variability / instability in patients diagnosed with COVID-19	24 months