TOCILIZUMAB - An Option for Patients With COVID-19 Associated Cytokine Release Syndrome; A Single Center Experience

NCT04730323 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: IRB# FMH-05-2020-IRB-75
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

Tocilizumab; Covid-19; SARS-CoV-2

Outcome Measures

Primary Outcomes (2)

• Decreased Mortality in Participants

  investigators tried to find out that whether there is decreased mortality in expermiental and active Comparator group or not

  30 days

• Hospital & ICU stay in days

  investigators tried to find out that whether there is decreased hospital and ICU stay in experimental group \& active Comparator

  14 days

Study Arms (2)

Tocilizumab Group

EXPERIMENTAL

Tocilizumab administration protocol: Patients received an initial dose calculated as per the body weight (8mg/kg) maximum 800mg/dose) over 1 hour, followed by up to three additional doses if required as per the response after the first dose with 8 hours intervals. Predefined Parameters of disease severity were assessed 12 to 24 hourly. Injection Paracetamol 1g was administered before infusion.

Drug: Tocilizumab

Methylprednisolone (corticosteroid) group

ACTIVE COMPARATOR

Corticosteroid administration protocol: Patients received methylprednisolone 80mg/day in two divided doses as per national/local guidelines and predefined parameters of disease severity were assessed on each day.

Drug: Tocilizumab

Interventions

Tocilizumab DRUG

Participants received an initial dose calculated as per the body weight (8mg/kg) maximum 800mg/dose) over 1 hour, followed by up to three additional doses if required as per the response after the first dose with 8 hours intervals. Predefined Parameters of disease severity were assessed 12 to 24 hourly. Injection Paracetamol 1g was administered before infusion. The response of the participants after Tocilizumab administration was recorded based on clinical parameters (Oxygen requirement, Fever, Need for invasive positive pressure ventilation), biochemical parameters (D-dimers, C-reactive protein (CRP), Ferritin, Lactate dehydrogenase (LDH) levels), Chest X-ray findings, and Repeated PCR test for COVID-19. Any side effects noted after administration of TOCILIZUMAB were recorded. Any side effects noted after administration of TCZ/ Corticosteroid were recorded.

Also known as: Experimental

Methylprednisolone (corticosteroid) group; Tocilizumab Group

Eligibility Criteria

• Age: 16 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• FMH College of Medicine and Dentistry: lead

Study Sites (1)

Fatima Memorial Hospital College of Medicine & Dentistry

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 33585031 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Aijaz Zeeshan Khan Chachar, MBBS,FCPS

  FMH College of Medicine & Dentistry

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Physician (Senior Registrar)

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: January 29, 2021
• Study Start: May 12, 2020
• Primary Completion: June 12, 2020
• Study Completion: June 12, 2020
• Last Updated: January 29, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Whenever will be asked to, within few days
• Access Criteria: Only officials can access the data

Locations

PA (1)