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

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: traditional Covid -19 therapy; Drug: Tocilizumab

• Registration Number: NCT04871854
• Lead Sponsor: Beni-Suef University

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-04-25
• Study Start: 2021-04-26
• Study First Submitted QC: 2021-05-01
• Study First Posted: 2021-05-04
• Primary Completion: 2022-07-26
• Study Completion: 2022-08-26
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Svere infected Covid-19 control	traditional Covid -19 therapy	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	Tocilizumab	Arm two patients with confirmed sever COVID 19 infection admitted to ICU with or without breast cancer patients comorbidity tocilizumab

Primary Outcome Measures

Name	Time	Method
progression free survival (PFS)	3 months	measure time from recovery until reinfection with Covid-19 after treatment of Tocilizumab
time of improvement or worsening at least one point change in ordinal scale	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
Overall survival (OS) after treatment of Tocilizumab	28 days time fram	measure mortality rate

Secondary Outcome Measures

Name	Time	Method
measure percentage of patients need Mechanical Ventilation Required (Including CPAP) during Follow up period, Supplemental Oxygen required	28 days time fram	complications
Duration of mechanical ventilation	28 days	Duration of mechanical ventilation from the start to end
adverse effect	28 days	any side effects or serious adverse effect
length of stay in Intensive care unit	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.

Trial Locations

Locations (1)

ALsafwa specialized hospital; 🇪🇬 Fayoum, Egypt