COVID-19 Infection in Cancer Pantients

Covid19 Clinical Trial

— COICA  

Official title:

Clinical Course of Cancer Patients Who Contracted COVID 19 Infection: An Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04569292
• Other study ID #: COICA_PAG_01
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: August 2021

Study information

• Verified date: September 2020
• Source: Ospedale Andrea Tortora di Pagani
• Contact: Data Manager Oncology Unit
• Phone: +390819213683
• Email: trialclinici.oncopagani[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

It's an obsevational retrospective/prospective study. Analyzing the evolution of COVID 19 infection in cancer patients can provide interesting information in the management of these patients. For this reason, the purpose of this study is to implement a registry to describe and monitor cancer patients affected by COVID 19, the factors that are associated with an unfavorable evolution, to develop a strategy for the risk assessment of these patients and recommendations. relating to their treatment.

Particular attention will be paid to patients suffering from urological tumors because the treatment followed by the patients would seem to expose them to a greater risk when they are infected with coronavirus, furthermore, from the literature it is clear that there may be a connection between sex hormones and ACE2 levels in the plasma. In fact, the estrons up-regulate the concentration of ACE2 in the circulation and this could be the reason why women would seem more protected than men once they contract the coronavirus infection

Description:

Primary objectives:

• describe cancer patients with COVID-19 and their clinical course;

• identify predictors of the most severe clinical course;

• identify prognostic factors; Secondary objectives

• Monitor patients with urological tumors with particular attention;

• Dosing parameters of inflammation such as IL-6 and IFNα;

• Measure the ACE2 levels.

Patients with oncological pathology who contracted COVID 19 infection from January 1, 2020 until the WHO declaration of the end of the pandemic will be studied.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 2021
• Est. primary completion date: April 2021
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• confirmation of COVID-19 in the laboratory (RT-PCR techniques);

• suspected cases of COVID-19; clinically diagnosed based on symptoms (fever> 37.5 °, decrease in oximeter saturation by at least 5%, cough, diarrhea, otitis, dysgeusia, myalgia, arthralgia, conjunctivitis and rhinorrhea) + close contact a COVID-19 subject positive;

• asymptomatic cases; diagnosed based on positive swab results but without symptoms even dead patients

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Covid19
• Infection

Intervention

Other:
• No intervention on patients
No intervention on patients

Locations

Country	Name	City	State
Italy	Oncology Unit, Hospital Andrea Tortora	Pagani	Salerno

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Andrea Tortora di Pagani

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	describe cancer patients with COVID-19 and their clinical course	Describing cancer patients with COVID-19 and their clinical course will help us to identify predictors of the most severe clinical course and also prognostic factors	Almost 1 year