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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04871854
• Other study ID #: REC-H-PHBSU-21010
• Status: Completed
• Phase: Phase 2
• Start date: April 26, 2021
• Est. completion date: August 26, 2022

Study information

• Verified date: October 2022
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 26, 2022
• Est. primary completion date: July 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Tocilizumab
patients treated with Tocilizumab for Covid-19 infection
• traditional Covid -19 therapy
patients treated with traditional therapy for Covid-19 infection

Locations

Country	Name	City	State
Egypt	ALsafwa specialized hospital	Fayoum

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS) after treatment of Tocilizumab	measure mortality rate	28 days time fram
Primary	progression free survival (PFS)	measure time from recovery until reinfection with Covid-19 after treatment of Tocilizumab	3 months
Primary	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	measure percentage of patients need Mechanical Ventilation Required (Including CPAP) during Follow up period, Supplemental Oxygen required	complications	28 days time fram
Secondary	Duration of mechanical ventilation	Duration of mechanical ventilation from the start to end	28 days
Secondary	adverse effect	any side effects or serious adverse effect	28 days
Secondary	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