Breast CancerPhase 2NCT04871854
Evaluating Tocilizumab for Sever COVID-19 Infection in Breast Cancer vs. Non Cancer Pateints
A Phase 2 study testing Tocilizumab and traditional Covid -19 therapy in people with Breast Cancer, run by Beni-Suef University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Tocilizumab and traditional Covid -19 therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Apr 2021to 26 Aug 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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
- Conditions
- Breast Cancer
- Being tested
- Tocilizumab, traditional Covid -19 therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocilizumabDrug
Also called Actemra
patients treated with Tocilizumab for Covid-19 infection
traditional Covid -19 therapyDrug
Also called DExa /Corticosteriods
patients treated with traditional therapy for Covid-19 infection
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS) after treatment of Tocilizumab
measure mortality rate
Measured: 28 days time fram
progression free survival (PFS)
measure time from recovery until reinfection with Covid-19 after treatment of Tocilizumab
Measured: 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
Measured: 28 days
Secondary outcomes (4)
measure percentage of patients need Mechanical Ventilation Required (Including CPAP) during Follow up period, Supplemental Oxygen required
complications
Measured: 28 days time fram
Duration of mechanical ventilation
Duration of mechanical ventilation from the start to end
Measured: 28 days
adverse effect
any side effects or serious adverse effect
Measured: 28 days
length of stay in Intensive care unit
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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start26 Apr 2021
- Primary completion26 Jul 2022
- Study completion26 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- comparative study two Covid-19 infected groups selected according to preexisting sever Covid -19 patients receiving Tocilizumab versus traditional thherapy
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ALshaimaa Ibrahim Rabie, Beni-Suef University
- Investigators
- Raghda Hussein, PHD, Study director, Beni suef university fculty of pharmacyAhmed Hassan shaaban, MD, Study director, clinical oncology faculty of medicine Beni suef universityDoaa Mahmoud, MD, Principal investigator, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871854
- Sponsor's protocol ID
- REC-H-PHBSU-21010
- Status last verified
- Oct 2022
- First submitted
- 25 Apr 2021
- Last updated
- 1 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04871854
- Acronym / sponsor ID
- REC-H-PHBSU-21010
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 26 Jul 2022 (actual)
- Study completion
- 26 Aug 2022 (actual)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- comparative study two Covid-19 infected groups selected according to preexisting sever Covid -19 patients receiving Tocilizumab versus traditional thherapy
| Arm | Type | Receives |
|---|---|---|
| Svere infected Covid-19 control | Experimental | Drug: traditional Covid -19 therapyArm one confirmed sever COVID 19 infection admitted to ICU including with or without breast cancer patients comorbidity receive traditional therapy |
| sever infected Covid -19 pateints study | Active comparator | Drug: TocilizumabArm two patients with confirmed sever COVID 19 infection admitted to ICU with or without breast cancer patients comorbidity tocilizumab |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (9 listed)
- above 85 years' old
- metatastic breast cancer
- autoimmune disease patients
- Unable to provide verbal informed consent
- preganncy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TocilizumabAlso: Actemrapatients treated with Tocilizumab for Covid-19 infection | Drug | sever infected Covid -19 pateints study |
| traditional Covid -19 therapyAlso: DExa /Corticosteriodspatients treated with traditional therapy for Covid-19 infection | Drug | Svere infected Covid-19 control |
Primary outcome
Overall survival (OS) after treatment of Tocilizumab
Time frame: 28 days time fram
measure mortality rate
progression free survival (PFS)
Time frame: 3 months
measure time from recovery until reinfection with Covid-19 after treatment of Tocilizumab
time of improvement or worsening at least one point change in ordinal scale
Time frame: 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
4 secondary outcomes
measure percentage of patients need Mechanical Ventilation Required (Including CPAP) during Follow up period, Supplemental Oxygen required
Time frame: 28 days time fram
Duration of mechanical ventilation
Time frame: 28 days
adverse effect
Time frame: 28 days
length of stay in Intensive care unit
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raghda Hussein, PHD study director
Beni suef university fculty of pharmacy
Ahmed Hassan shaaban, MD study director
clinical oncology faculty of medicine Beni suef university
Doaa Mahmoud, MD principal investigator
Beni-Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tocilizumab and traditional Covid -19 therapy in people with Breast Cancer, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) after treatment of Tocilizumab (time frame: 28 days time fram). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.