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

Comparative Study Evaluating Clinical Outcomes for Patients Treated With Tocilizumab for Sever COVID-19 Infection in Breast Cancer Patients Versus Non Cancer Patients

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

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: traditional Covid -19 therapy; Drug: Tocilizumab

Detailed 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 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
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Fayoum, Egypt, 11454
    • ALsafwa specialized hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Svere infected Covid-19 control; Arm one confirmed sever COVID 19 infection admitted to ICU including with or without breast cancer patients comorbidity receive traditional therapy	Drug: traditional Covid -19 therapy; patients treated with traditional therapy for Covid-19 infection; Other Names: DExa /Corticosteriods
Active Comparator: sever infected Covid -19 pateints study; Arm two patients with confirmed sever COVID 19 infection admitted to ICU with or without breast cancer patients comorbidity tocilizumab	Drug: Tocilizumab; patients treated with Tocilizumab for Covid-19 infection; Other Names: Actemra

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Beni-Suef University
• 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

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2021
• Primary Completion (Actual): July 26, 2022
• Study Completion (Actual): August 26, 2022

Study Registration Dates

• First Submitted: April 25, 2021
• First Submitted That Met QC Criteria: May 1, 2021
• First Posted (Actual): May 4, 2021

Study Record Updates

• Last Update Posted (Actual): November 1, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: REC-H-PHBSU-21010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No