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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Svere infected Covid-19 control | Experimental | Arm one confirmed sever COVID 19 infection admitted to ICU including with or without breast cancer patients comorbidity receive traditional therapy |
|
| sever infected Covid -19 pateints study | Active Comparator | Arm two patients with confirmed sever COVID 19 infection admitted to ICU with or without breast cancer patients comorbidity tocilizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocilizumab | Drug | patients treated with Tocilizumab for Covid-19 infection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) after treatment of Tocilizumab | measure mortality rate | 28 days time fram |
| progression free survival (PFS) | measure time from recovery until reinfection with Covid-19 after treatment of Tocilizumab | 3 months |
| time of improvement or worsening at least one point change in ordinal scale | 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 | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| measure percentage of patients need Mechanical Ventilation Required (Including CPAP) during Follow up period, Supplemental Oxygen required | complications | 28 days time fram |
| Duration of mechanical ventilation |
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Inclusion Criteria:
patients admitted to ICU with or without breast cancer (non-metastatic) comorbidity
age 18-85 years' old
moderate to sever confirmed COVID 19 infection through PCR and CT
male or female
confirmed Covid-19 by PCR
Requiring ICU admission
WITH evidence of severe COVID-19 (at least 2 of the following):
AND at least 1 of the following:
all patient assigned informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raghda Hussein, PHD | Beni suef university fculty of pharmacy | Study Director |
| Ahmed Hassan shaaban, MD | clinical oncology faculty of medicine Beni suef university | Study Director |
| Doaa Mahmoud, MD | Beni-Suef University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ALsafwa specialized hospital | Al Fayyum | 11454 | Egypt |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C502936 | tocilizumab |
| D015502 | Absorptiometry, Photon |
| ID | Term |
|---|---|
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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comparative study two Covid-19 infected groups selected according to preexisting sever Covid -19 patients receiving Tocilizumab versus traditional thherapy
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| traditional Covid -19 therapy | Drug | patients treated with traditional therapy for Covid-19 infection |
|
|
Duration of mechanical ventilation from the start to end
| 28 days |
| adverse effect | any side effects or serious adverse effect | 28 days |
| length of stay in Intensive care unit | 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. | 28 days |
| D017437 |
| Skin and Connective Tissue Diseases |
| D003720 |
| Densitometry |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |