Status:
COMPLETED
TOCILIZUMAB - An Option for Patients With COVID-19 Associated Cytokine Release Syndrome; A Single Center Experience
Lead Sponsor:
FMH College of Medicine and Dentistry
Conditions:
Covid19
Eligibility:
All Genders
16-85 years
Phase:
PHASE4
Brief Summary
Investigators conducted this study to see the effectiveness of Tocilizumab in COVID-19 participants who were in cytokine release syndrome and there was also a control group who received steroids(RECOV...
Detailed Description
Objectives: To analyze the effectiveness of Tocilizumab in moderate to severe Covid-19 participants on the basis of predefined assessment criteria. Study Settings: Single center, Fatima Memorial Hosp...
Eligibility Criteria
Inclusion
- All patients diagnosed with COVID-19 infection with positive reverse transcriptase RT-PCR test, willing to participate in this study or PCR negative patients with clinically COVID-19 Pneumonia in cytokine storm as evidenced by raised inflammatory markers with typical radiological changes
- Patients of both genders were included
- Patients having an age of \> 65 years with proven Cardiomyopathy, Coronary artery disease, chronic lung disease, Immunosuppressed or organ transplant End-stage renal disease on history \& examination and medical records and having any 1 out of 4 Fever 0f
- ≥39 C
- Hypotension or drop in mean arterial pressure of \> 10mmHg
- Progressive Hypoxemia requiring \> 5 liters of oxygen
- Sustained Respiratory rate \>30/min with any 2 laboratory parameters out of 3 are present D-dimers ≥ 1000 ng/ml C-reactive protein CRP ≥ 100mg/L Ferritin ≥ 600ng/ml
- Patients having low risk or no comorbidities and having an age of \<65 years with having any 3 out of 4 Fever 0f
- ≥39 C
- Hypotension or drop in mean arterial pressure of \> 10mmHg
- Progressive Hypoxemia requiring \> 5 liters of oxygen
- Sustained Respiratory rate \>30/min With any 2 laboratory parameters out of 3 are present D-dimers ≥ 1000 ng/ml C-reactive protein CRP ≥ 100mg/L Ferritin ≥ 600ng/ml
- Moderate severe or severe COVID 19 features
- Shortness of breath oxygen saturation \<93% on room air
- Progressive Hypoxemia requiring \> 5 liters of oxygen
- Respiratory rate \>30/min
- The partial pressure of arterial oxygen to fraction of inspired oxygen ratio\<300
- Lung infiltrates on Chest x-ray CXR \>50% within 24 to 48 hrs
- Respiratory failure
Exclusion
- Known severe allergic reactions to Tocilizumab or any other monoclonal antibody
- Pregnancy or breastfeeding
- Absolute Neutrophil Count(ANC) \< 1000
- Alanine aminotransferase(ALT) or aspartate aminotransferase (AST) \> 5 times upper normal limit
- Platelet count of \< 50,000
- Bowel diverticulitis or bowel perforation
- Patients having Acute pancreatitis
Key Trial Info
Start Date :
May 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 12 2020
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT04730323
Start Date
May 12 2020
End Date
June 12 2020
Last Update
January 29 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fatima Memorial Hospital College of Medicine & Dentistry
Lahore, Punjab Province, Pakistan, 54000