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

Sponsor
Beni-Suef University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04871854
Collaborator
(none)
60
1
2
16
3.8

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
comparative study two Covid-19 infected groups selected according to preexisting sever Covid -19 patients receiving Tocilizumab versus traditional thherapycomparative study two Covid-19 infected groups selected according to preexisting sever Covid -19 patients receiving Tocilizumab versus traditional thherapy
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 26, 2021
Anticipated Primary Completion Date :
Jul 26, 2022
Anticipated Study Completion Date :
Aug 26, 2022

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Overall survival (OS) after treatment of Tocilizumab [28 days time fram]

      measure mortality rate

    2. progression free survival (PFS) [3 months]

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

    3. 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

    Secondary Outcome Measures

    1. measure percentage of patients need Mechanical Ventilation Required (Including CPAP) during Follow up period, Supplemental Oxygen required [28 days time fram]

      complications

    2. Duration of mechanical ventilation [28 days]

      Duration of mechanical ventilation from the start to end

    3. adverse effect [28 days]

      any side effects or serious adverse effect

    4. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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):

    8. Fever > 38C within 72 hours

    9. Pulmonary infiltrate on chest X ray /ground glass opacity

    10. Need for supplemental O2 to maintain saturation > 92%

    11. AND at least 1 of the following:

    12. Ferritin > 500 ng/ml

    13. CRP > 50 mg/L

    14. LDH >250 U/L

    15. D-dimer > 1000 ng/mL

    16. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ALsafwa specialized hospital Fayoum Egypt 11454

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ALshaimaa Ibrahim Rabie, Assistant lecturer , pharm D, October 6 University, Beni-Suef University
    ClinicalTrials.gov Identifier:
    NCT04871854
    Other Study ID Numbers:
    • REC-H-PHBSU-21010
    First Posted:
    May 4, 2021
    Last Update Posted:
    Mar 18, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 18, 2022