Evaluating Tocilizumab for Sever COVID-19 Infection in Breast Cancer vs. Non Cancer Pateints

Beni-Suef University100 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Breast Cancer

Interventions

TocilizumabDRUG

patients treated with Tocilizumab for Covid-19 infection

traditional Covid -19 therapyDRUG

patients treated with traditional therapy for Covid-19 infection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. patients admitted to ICU with or without breast cancer (non-metastatic) comorbidity 2. age 18-85 years' old 3. moderate to sever confirmed COVID 19 infection through PCR and CT 4. male or female 5. confirmed Covid-19 by PCR 6. Requiring ICU admission 7. WITH evidence of severe COVID-19 (at least 2 of the following): 1. Fever \> 38C within 72 hours 2. Pulmonary infiltrate on chest X ray /ground glass opacity 3. Need for supplemental O2 to maintain saturation \> 92% 8. AND at least 1 of the following: 1. Ferritin \> 500 ng/ml 2. CRP \> 50 mg/L 3. LDH \>250 U/L 4. D-dimer \> 1000 ng/mL 9. all patient assigned informed consent Exclusion Criteria: 1. above 85 years' old 2. metatastic breast cancer 3. autoimmune disease patients 4. Unable to provide verbal informed consent 5. preganncy 6. Subjects between the ages of 70 and 75 will be excluded if they have NYHA Class III/IV heart failure 7. Active TB 8. Receipt of IV tocilizumab for the treatment of a non-COVID condition within 3 weeks of the first COVID symptom 9. History of hypersensitivity to tocilizumab 7. ANC \<500, Platelets \<50,000\* 8. AST/ALT \> 5X ULN

Locations (1)

ALsafwa specialized hospital

Al Fayyum, Egypt

Outcomes

Primary Outcomes

Overall survival (OS) after treatment of Tocilizumab

measure mortality rate

Time frame: 28 days time fram

progression free survival (PFS)

measure time from recovery until reinfection with Covid-19 after treatment of Tocilizumab

Time frame: 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

Time frame: 28 days

Secondary Outcomes

measure percentage of patients need Mechanical Ventilation Required (Including CPAP) during Follow up period, Supplemental Oxygen required

complications

Time frame: 28 days time fram

Duration of mechanical ventilation

Duration of mechanical ventilation from the start to end

Time frame: 28 days

adverse effect

any side effects or serious adverse effect

Time frame: 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.

Data from ClinicalTrials.gov

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