Toclizumam Versus Dexamethasone in Severe Covid-19 Cases
Primary Purpose
Pneumonia, Viral
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Tocilizumab
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Pneumonia, Viral focused on measuring COVID19, Tocilizumab, dexamethsone
Eligibility Criteria
Inclusion Criteria:
- respiratory rate > 30 cycle/minute, Bilateral CT infiltration > 30%, PaO2/FiO2 ratio <150 or saturation <90 on >6L/min, Two positive laboratory tests of: (CRP>100 g/dL, lymphocytes<600 /mm3, D dimer>L, Ferritin >500)
Exclusion Criteria:
- Pediatric patients < 18 years old, patients with active bacterial or fungal infection and patients who were not requiring supplemental oxygen
Sites / Locations
- Qena faculty medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tocilizumab
Dexamethasone
Arm Description
Tocilizumab
Dexamethasone therapy
Outcomes
Primary Outcome Measures
Proportion of participants with Overall Survival at 14 days
survival 14 days from admission date
Secondary Outcome Measures
Fio2/Pao2
Change in Fio2/Pao2
Full Information
NCT ID
NCT04519385
First Posted
August 17, 2020
Last Updated
August 21, 2020
Sponsor
South Valley University
1. Study Identification
Unique Protocol Identification Number
NCT04519385
Brief Title
Toclizumam Versus Dexamethasone in Severe Covid-19 Cases
Official Title
Toclizumam Versus Dexamethasone in Severe Covid-19 Cases
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
August 5, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Valley University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
randomized controlled trial comparing survival benefit of Tocilizumab therapy with dexamethasone in patients with severe COVID 19
Detailed Description
The current study takes place in the ICU of ESNA hospital, the first COVID-19 quarantine hospital in Egypt, located in Upper Egypt, Luxor governorate during the period from March 2020 to June 2020.
The diagnosis of COVID-19 was made with a positive RT-PCR assay performed on a nasal swab. We have collected data on patients' demographics, comorbidities, symptoms, oxygen support, the ratio of partial pressure of arterial oxygen over the fraction of inspired oxygen (PaO2/FiO2 ratio), laboratory values (complete blood count, CRP, D-Dimer, ferritin, AST, ALT), diagnostic workup, therapies, complications, and outcomes.
Patients were given conventional treatment for COVID-19, including, hydroxychloroquine with a loading dose of 400 mg twice daily followed by 200 mg per day twice daily for additional five days and azithromycin 500 mg per day for five days unless contraindicated. An electrocardiogram was obtained for each patient to check the corrected QT interval at baseline.
In addition to conventional treatment, patients were randomly assigned to either dexamethasone group or tocilizumab (TCZ) group according to random tables.
Eligibility for study included patients with significant deterioration in respiratory clinical status with respiratory rate > 30 cycle/minute, Bilateral CT infiltration > 30%, PaO2/FiO2 ratio <150 or saturation <90 on >6L/min, Two positive laboratory tests of: (CRP>100 g/dL, lymphocytes<600 /mm3, D dimer>L, Ferritin >500).Interleukin 6 levels were not part of the criteria because it did not necessarily result in an actionable time frame.
Pediatric patients < 18 years old, patients with an active bacterial or fungal infection, and patients who were not requiring supplemental oxygen were excluded from the study.
No sample-size calculations were performed. The endpoint was time to failure, defined as death, within 14 days from ICU admission. Patients with a very early death reduced the risk that the treatment choice was motivated by the patient's disease course. Therefore, day 3 from hospital admission was set as a landmark time point: those who died, before the 3rd day of ICU admission, were excluded.
Treatment groups: Dexamethasone pulse therapy group:
All patients within this group received pulse Dexamethasone 4 mg/kg/day in an infusion form for the 3rd day, followed by a maintenance dose of 8 mg/day for 10 days with a subsequent withdrawal.
Tocilizumab group: Patients within this group received TCZ, 4 mg/kg/dose in 100 ccs normal saline over one hour. The same dose was repeated after 24h if there is no improvement in clinical assessment, corticosteroids (Solu-Medrol 40 mg for 5 days then 20 mg for 5 days) was added.
Data was collected at day one of treatment initialization, except for (PaO2/FiO2 ratio), which is also collected after 2 days from the end of the treatment and overall mortality within 14 days.
All patients provided informed consent for treatment with off label agents according to the local protocol approved by Hospital Authorities, for data collection and for participation in the study. The study was carried out in accordance with the principles of the Declaration of Helsinki and approved by the Regional Ethics Committee, Qena faculty of medicine, South-Vally University.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Viral
Keywords
COVID19, Tocilizumab, dexamethsone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
dexamethsone group Tocilizumab group
Masking
ParticipantOutcomes Assessor
Masking Description
single blind
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tocilizumab
Arm Type
Experimental
Arm Description
Tocilizumab
Arm Title
Dexamethasone
Arm Type
Active Comparator
Arm Description
Dexamethasone therapy
Intervention Type
Drug
Intervention Name(s)
Tocilizumab
Other Intervention Name(s)
TCZ
Intervention Description
Tocilizumab therapy
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
dexamethsone pulse therapy
Intervention Description
dexamethsone pulse therapy
Primary Outcome Measure Information:
Title
Proportion of participants with Overall Survival at 14 days
Description
survival 14 days from admission date
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Fio2/Pao2
Description
Change in Fio2/Pao2
Time Frame
2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
respiratory rate > 30 cycle/minute, Bilateral CT infiltration > 30%, PaO2/FiO2 ratio <150 or saturation <90 on >6L/min, Two positive laboratory tests of: (CRP>100 g/dL, lymphocytes<600 /mm3, D dimer>L, Ferritin >500)
Exclusion Criteria:
Pediatric patients < 18 years old, patients with active bacterial or fungal infection and patients who were not requiring supplemental oxygen
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alaa R rashad, MD
Organizational Affiliation
South Valley University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qena faculty medicine
City
Qinā
ZIP/Postal Code
83523
Country
Egypt
12. IPD Sharing Statement
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Toclizumam Versus Dexamethasone in Severe Covid-19 Cases
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