Clinical trial NCT04871854: Evaluating Tocilizumab for Sever COVID-19 Infection in Breast Cancer vs. Non Cancer Pateints
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: comparative study two Covid-19 infected groups selected according to preexisting sever Covid -19 patients receiving Tocilizumab versus traditional thherapy
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival (OS) after treatment of Tocilizumab
timeFrame: 28 days time fram
measure: progression free survival (PFS)
timeFrame: 3 months
measure: time of improvement or worsening at least one point change in ordinal scale
timeFrame: 28 days
Secondary outcomes:
measure: measure percentage of patients need Mechanical Ventilation Required (Including CPAP) during Follow up period, Supplemental Oxygen required
timeFrame: 28 days time fram
measure: Duration of mechanical ventilation
timeFrame: 28 days
measure: adverse effect
timeFrame: 28 days
measure: length of stay in Intensive care unit
timeFrame: 28 days
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: ALsafwa specialized hospital
Study officials:
affiliation: Beni suef university fculty of pharmacy
name: Raghda Hussein, PHD
role: STUDY_DIRECTOR
affiliation: clinical oncology faculty of medicine Beni suef university
name: Ahmed Hassan shaaban, MD
role: STUDY_DIRECTOR
affiliation: Beni-Suef University
name: Doaa Mahmoud, MD
role: PRINCIPAL_INVESTIGATOR
References: