Status:
COMPLETED
Comparison of Tocilizumab Versus Tocilizumab/Infliximab in Patients With COVID-19-associated Cytokine Storm Syndrome
Lead Sponsor:
Ain Shams University
Collaborating Sponsors:
Misr International University
Conditions:
Covid19
Cytokine Storm
Eligibility:
All Genders
18-65 years
Brief Summary
Since the end of 2019, Egypt and the whole world have been suffering from the Coronavirus Disease 2019 (COVID-19) pandemic, which is caused by the severe acute respiratory syndrome coronavirus 2 (SARS...
Eligibility Criteria
Inclusion
- Age 18-65 years.
- Able to provide informed consent.
- Patients hospitalized with pneumonia proved by chest X-ray or CT scan.
- Confirmed infection with COVID-2019 using RT-PCR or strongly suspected to be infected with pending confirmation studies.
- Hyper-inflammation defined as elevation in either C-reactive protein (CRP, ≥ 100 mg/L, normal values \<6 mg/L) or ferritin (≥ 900 ng/mL, normal value \<400 ng/mL), in the presence of increased lactate dehydrogenase (LDH, \>220 U/L).
- And at least one of the following:
- Respiratory frequency ≥30/min.
- Blood oxygen saturation ≤93% on room air (RA).
- Partial pressure of arterial oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) \<300 \[18\].
- Worsening of lung involvement, defined as an increase in number and/or extension of pulmonary areas of consolidation, need for increased FiO2 to maintain stable O2 saturation, or worsening O2 saturation of \>3% with stable FiO2.
Exclusion
- Evidence of concomitant bacterial infection.
- Concomitant use of other immunosuppressive biologic drugs.
- Baseline elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \> 5-fold the upper limit of the normal range.
- Pregnancy.
- Treatment with any TNFα inhibitor in the past 30 days.
- Known hypersensitivity to any TNFα inhibitor, murine proteins, or any component of the formulation.
- Known or suspected active tuberculosis (TB) or a history of incompletely treated or latent TB.
- Serious co-morbidity, including:
- Myocardial infarction (within last month).
- Moderate or severe heart failure (New York Heart Association (NYHA) class III or IV).
- Hepatic patients child Pugh class C.
Key Trial Info
Start Date :
December 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2021
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT04734678
Start Date
December 1 2020
End Date
August 1 2021
Last Update
July 20 2022
Active Locations (1)
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1
Teachers Hospital
Cairo, Please Select, Egypt, 11314