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

NCT04871854 | Completed Phase 2

• 1 other identifier: REC-H-PHBSU-21010
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• measure percentage of patients need Mechanical Ventilation Required (Including CPAP) during Follow up period, Supplemental Oxygen required

  28 days time fram

• Duration of mechanical ventilation

  28 days

• adverse effect

  28 days

• length of stay in Intensive care unit

  28 days

Study Arms (2)

Svere infected Covid-19 control

EXPERIMENTAL

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

sever infected Covid -19 pateints study

ACTIVE COMPARATOR

Arm two patients with confirmed sever COVID 19 infection admitted to ICU with or without breast cancer patients comorbidity tocilizumab

Drug: Tocilizumab

Interventions

Tocilizumab DRUG

patients treated with Tocilizumab for Covid-19 infection

Also known as: Actemra

sever infected Covid -19 pateints study

traditional Covid -19 therapy DRUG

patients treated with traditional therapy for Covid-19 infection

Also known as: DExa /Corticosteriods

Svere infected Covid-19 control

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients admitted to ICU with or without breast cancer (non-metastatic) comorbidity
• age 18-85 years' old
• moderate to sever confirmed COVID 19 infection through PCR and CT
• male or female
• confirmed Covid-19 by PCR
• Requiring ICU admission
• WITH evidence of severe COVID-19 (at least 2 of the following):
• Fever \> 38C within 72 hours
• Pulmonary infiltrate on chest X ray /ground glass opacity
• Need for supplemental O2 to maintain saturation \> 92%
• AND at least 1 of the following:
• Ferritin \> 500 ng/ml
• CRP \> 50 mg/L
• LDH \>250 U/L
• D-dimer \> 1000 ng/mL

You may not qualify if:

• above 85 years' old
• metatastic breast cancer
• autoimmune disease patients
• Unable to provide verbal informed consent
• preganncy
• Subjects between the ages of 70 and 75 will be excluded if they have NYHA Class III/IV heart failure
• Active TB
• Receipt of IV tocilizumab for the treatment of a non-COVID condition within 3 weeks of the first COVID symptom
• History of hypersensitivity to tocilizumab 7. ANC \<500, Platelets \<50,000\* 8. AST/ALT \> 5X ULN

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

ALsafwa specialized hospital

Al Fayyum, 11454, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

tocilizumab; Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Raghda Hussein, PHD

  Beni suef university fculty of pharmacy

  STUDY DIRECTOR

• Ahmed Hassan shaaban, MD

  clinical oncology faculty of medicine Beni suef university

  STUDY DIRECTOR

• Doaa Mahmoud, MD

  Beni-Suef University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer , pharm D, October 6 University

Model Details: comparative study two Covid-19 infected groups selected according to preexisting sever Covid -19 patients receiving Tocilizumab versus traditional thherapy

Study Record Dates

• First Submitted: April 25, 2021
• First Posted: May 4, 2021
• Study Start: April 26, 2021
• Primary Completion: July 26, 2022
• Study Completion: August 26, 2022
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)