NCT04457570: ONCOVID-AURA

Excess Risk of Morbi-mortality Due to COVID-19 in Patients With Cancer

Status unknown Last updated 7 July 2020

What this trial tests

trial testing mortality in COVID, Cancer in 600 participants. Status unknown.

Timeline

15 June 2020

Primary endpoint
15 December 2020

15 February 2021

Quick facts

Lead sponsor	Hospices Civils de Lyon
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	600
Start date	15 June 2020
Primary completion	15 December 2020
Estimated completion	15 February 2021
Sites	5 locations across France

Drugs / interventions tested

• mortality

Conditions studied

• COVID, Cancer — all drugs for COVID, Cancer →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

18 and older, any sex, with COVID, Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Context:

Based on currently available data, most of national health authorities and consensus expert groups have written guidelines for the management of cancer patients in the context of COVID. However, the preparation of these guidelines was limited by the scarcity of solid epidemiological data. For example, the experts were uncomfortable to formulate precise guidelines on which anti-cancer treatment should be interrupted or replaced, on which patients, and how to adapt supportive drug prescriptions.

Objectives :

* To measure the excess risk of mortality and morbidity of patients with a history of cancer among patients hospitalized for a SARS-CoV-2 infection.
* To identify factors associated with the risk of death and morbidity among patients with cancer.

Methodology:

Retrospective inclusion of n=200 cancer patients hospitalized for COVID and n=400 matched (based on age, gender, and comorbidity) non-cancer patients hospitalized for COVID. Two analyses will be performed (after the inclusion of n=100 and n=200 patients with cancer). A logistic modeling of the odds ratio of death associated to the exposition factor (i.e. cancer) and adjusted for the matching parameters (age, gender, comorbidities) will be proposed.

We will then look for the factors (related to the patients, the cancer or the treatment) that modify the odds radio.

Expected results:

The data generated will help the medical and scientific community to evaluate the increasing risk of cancer patients infected by SARS-CoV-2 compared to the non-cancer population, to identify patients at higher risk of severe infection, but also the anticancer treatments associated with an increased risk of severe infections.

Impact:

These data will contribute to guide the future recommendations concerning cancer patient's care in the context of the COVID-19 pandemic. There is a real risk that the SARS-CoV epidemic, or other respiratory viruses epidemic, will become recurrent in the future. Thus, it is of crucial importance for now and for the future to know which are the major factors associated with severe infections

Publications & conference data

No peer-reviewed publications indexed yet for this trial.