Status:
COMPLETED
Evaluating Tocilizumab for Sever COVID-19 Infection in Breast Cancer vs. Non Cancer Pateints
Lead Sponsor:
Beni-Suef University
Conditions:
Breast Cancer
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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 a...
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...
Eligibility Criteria
Inclusion
- 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
- all patient assigned informed consent
Exclusion
- 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
Key Trial Info
Start Date :
April 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 26 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04871854
Start Date
April 26 2021
End Date
August 26 2022
Last Update
November 1 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
ALsafwa specialized hospital
Al Fayyum, Egypt, 11454