COVID, Cancer Clinical Trial
— ONCOVID-AURAOfficial title:
ONCOVID-AURA: Excess Risk of Morbi-mortality Due to COVID-19 in Patients With Cancer
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
| Status | Recruiting |
| Enrollment | 600 |
| Est. completion date | February 15, 2021 |
| Est. primary completion date | December 15, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - EXPOSED PATIENTS: - Age > 18 years old - Patients with a confirmed diagnosis of solid or hematologic cancer - Patients who received their last anticancer treatment (surgery, systemic treatments or other localized treatment) in the past 5 years before SARS-CoV-2 infection - Positive laboratory test (RT-PCR) proving the SARS-CoV-2 infection - Patients hospitalized in one of the participating centers because of the SARS-CoV-2 infection - Patients who are not opposed in participating to the ONCOVID-AURA study CONTROL PATIENTS: - Age > 18 years old - Patients who have no cancer (neither solid nor hematologic tumors) or patients who received their last anticancer treatments more than five years before the SARS-CoV-2 infection - Positive laboratory test (RT-PCR) proving the SARS-CoV-2 infection - Patients hospitalized in one of the participating centers because of the SARS-CoV-2 infection - Patients who are not opposed in participating to the ONCOVID-AURA study Exclusion Criteria: - none |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre de lutte contre le Cancer JEAN PERRIN | Clermont-Ferrand | |
| France | Centre Hospitalier Uniersitaire de Clermont-Ferrand | Clermont-Ferrand | |
| France | Centre Leon Berard | Lyon | |
| France | Centre Hospitalier Universitaire de St Etienne | Saint-Étienne | |
| France | Institut de Cancérologie de la Loire Lucien Neurwirth | Saint-Priest-en-Jarez |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | mortality for SARS-CoV-2 infection | mortality within 30 days after the hospitalization for the SARS-CoV-2 infection | 30 days |