ALsafwa specialized hospital
Al Fayyum, 11454, Egypt
NCT Number: NCT04871854
To compare evaluating Clinical outcomes for patients treated with with or without breast cancer patients comorbidity for sever COVID-19 infection in breast cancer patients versus non cancer patients and evaluating Tocilizumab efficacy versus traditional therapy
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Notify Me18 year–85 year
All sexes
Interventional
Phase 2
Al Fayyum, 11454, Egypt
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
patients treated with Tocilizumab for Covid-19 infection
Other names: Actemra
patients treated with traditional therapy for Covid-19 infection
Other names: DExa /Corticosteriods
Time frame: 28 days time fram
measure mortality rate
Time frame: 3 months
measure time from recovery until reinfection with Covid-19 after treatment of Tocilizumab
Time frame: 28 days
Time to improvement will be assessed by changes on the clinical improvement or worsening as it measures illness severity over time ,by using Ordinal Scale for Clinical Improvement which score zero indicate no clinical or evidence virologic infection and high score 8 indicate death
Time frame: 28 days time fram
complications
Time frame: 28 days
Duration of mechanical ventilation from the start to end
Time frame: 28 days
any side effects or serious adverse effect
Time frame: 28 days
admission date and discharge date documented and LOS calculated from the day of admission to day of discharge, and based on the number of nights spent in hospital. Patients admitted and discharged on the same day have a length of stay of less than one day. dividing the sum of inpatient days by the number of patients admissions.
Beni-Suef University
Other
Comparative Study Evaluating Clinical Outcomes for Patients Treated With Tocilizumab for Sever COVID-19 Infection in Breast Cancer Patients Versus Non Cancer Patients
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