Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Breast Cancer
Type
Interventional
Phase
Phase 2
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: comparative study two Covid-19 infected groups selected according to preexisting breast cancer and the other arm non cancer patientsMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 75 years
Gender
Both males and females

Description

Cancer patients considered to be one of the least population that can be considered lucky during COVID 19 pandemic attributed that to long term treatment with chemotherapy, immunosuppression and multi comorbidities . Women with breast cancer are more likely to get covid-19 infection rather than othe...

Cancer patients considered to be one of the least population that can be considered lucky during COVID 19 pandemic attributed that to long term treatment with chemotherapy, immunosuppression and multi comorbidities . Women with breast cancer are more likely to get covid-19 infection rather than other type cancers . the co-existing of two diseases breast cancer and Covid19 are very challengeable due to confusion and similarities found in clinical biomarkers to evaluate both diseases as ferritin, D dimers and C-reactive protein and all other immune response and cytokine storm syndrome especially including interleukin-6 (IL-6) . using chemotherapy or any other cytotoxic drugs may exacerbate the severity of COVID -19 infection as well as poor clinical outcomes and even death are expected . The anti-human IL-6R monoclonal antibody (Tocilizumab) was used first in China in patients with severe COVID-19 and patients improved in different clinical outcome . In cancer patients particularly the issue is debatable about the benefits of receiving Tocilizumab. Clinical studies are going on such medication role in treatment of patients with severe covid 19 infection however, studies have not clearly addressed the role of Tocilizumab breast cancer patient compared to non-cancer patients. This study aims to measure different clinical outcomes after using Tocilizumab in sever covid 19 infection in breast cancer patients vs. non cancer patients

Tracking Information

NCT #
NCT04871854
Collaborators
Not Provided
Investigators
Study Director: Raghda Hussein, PHD Beni suef university fculty of pharmacy Study Director: Ahmed Hassan shaaban, MD clinical oncology faculty of medicine Beni suef university Principal Investigator: Doaa Mahmoud, MD Beni-Suef University