Clinical trial NCT04730323: TOCILIZUMAB - An Option for Patients With COVID-19 Associated Cytokine Release Syndrome; A Single Center Experience
Official title: TOCILIZUMAB - An Option for Patients With COVID-19 Associated Cytokine Release Syndrome; A Single Center Experience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Covid19
Keywords: Tocilizumab
Covid-19
SARS-CoV-2
Lead sponsor: FMH College of Medicine and Dentistry
Sponsor class: OTHER
First posted: 2021-01-29
Enrollment: 93
Sex: ALL
Minimum age (years): 16
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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(RECOVERY TRIAL wasn't published or available at that time) this study was conducted in the early days of 1st wave of COVID in our country Pakistan so it was need of the day to develop some national guidelines on the basis of multiple studies' results from Pakistan.

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 Hospital, Lahore.

Study Design: Quasi experimental.

Duration of Study: From 12th May, 2020 to 12th July, 2020.

Participants \& Methods: Sample size and technique: Sample size was 93; 33 participants were kept in experimental group, given Tocilizumab, 8mg/kg intravenously or 162 mg subcutaneously and rest of the 60 participants were given corticosteroids, methylprednisolone 80 mg/day. Consecutive sampling.

Failure of therapy was labeled when participants were intubated or died, and the endpoints were failure-free survival which was the primary endpoint and overall survival secondary at the time of discharge.

Eligibility criteria: * Inclusion Criteria:

  * 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

    1. Shortness of breath oxygen saturation \<93% on room air
    2. Progressive Hypoxemia requiring \> 5 liters of oxygen
    3. Respiratory rate \>30/min
    4. The partial pressure of arterial oxygen to fraction of inspired oxygen ratio\<300
    5. Lung infiltrates on Chest x-ray CXR \>50% within 24 to 48 hrs
    6. Respiratory failure
* Exclusion Criteria:

  * 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

Primary outcomes:
measure: Decreased Mortality in Participants
timeFrame: 30 days
measure: Hospital & ICU stay in days
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Fatima Memorial Hospital College of Medicine & Dentistry
state: Punjab
Study officials:
affiliation: FMH College of Medicine & Dentistry
name: Aijaz Zeeshan Khan Chachar, MBBS,FCPS
role: STUDY_DIRECTOR
References:
citation: Chachar AZK, Khan KA, Iqbal J, Shahid AH, Asif M, Fatima SA, Khan AA, Younis BB. "Tocilizumab-an option for patients with COVID-19 associated cytokine release syndrome: A single center experience", a retrospective study-original article. Ann Med Surg (Lond). 2021 Mar;63:102165. doi: 10.1016/j.amsu.2021.02.011. Epub 2021 Feb 8.