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

• Status: Recruiting
• Trial end date: 2022-08-26
• Target enrollment: 0
• Participant gender: All

Summary

To compare evaluating Clinical outcomes for patients treated with Tocilizumab for sever COVID-19 infection in breast cancer patients versus non cancer patients

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beni-Suef University

Criteria

Inclusion Criteria:

1. patients admitted to ICU with breast cancer (non-metastatic)

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