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

Primary Purpose

Covid19

Status

Completed

Phase

Phase 4

Locations

Pakistan

Study Type

Interventional

Intervention

Tocilizumab

About this trial

This is an interventional treatment trial for Covid19 focused on measuring Tocilizumab, Covid-19, SARS-CoV-2

Eligibility Criteria

16 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Fatima Memorial Hospital College of Medicine & Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tocilizumab Group

Methylprednisolone (corticosteroid) group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Decreased Mortality in Participants

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

Hospital & ICU stay in days

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04730323

First Posted

January 26, 2021

Last Updated

January 28, 2021

Sponsor

FMH College of Medicine and Dentistry

1. Study Identification

Unique Protocol Identification Number

NCT04730323

Brief Title

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

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

May 12, 2020 (Actual)

Primary Completion Date

June 12, 2020 (Actual)

Study Completion Date

June 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

FMH College of Medicine and Dentistry

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

Keywords

Tocilizumab, Covid-19, SARS-CoV-2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

93 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tocilizumab Group

Arm Type

Experimental

Arm Description

Arm Title

Methylprednisolone (corticosteroid) group

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Tocilizumab

Other Intervention Name(s)

Experimental

Intervention Description

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.

Primary Outcome Measure Information:

Title

Decreased Mortality in Participants

Description

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

Time Frame

30 days

Title

Hospital & ICU stay in days

Description

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

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aijaz Zeeshan Khan Chachar, MBBS,FCPS

Organizational Affiliation

FMH College of Medicine & Dentistry

Official's Role

Study Director

Facility Information:

Facility Name

Fatima Memorial Hospital College of Medicine & Dentistry

City

Lahore

State/Province

Punjab

ZIP/Postal Code

54000

Country

Pakistan

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

IPD can be shared with researchers in future too

IPD Sharing Time Frame

Whenever will be asked to, within few days

IPD Sharing Access Criteria

Only officials can access the data

Citations:

PubMed Identifier

33585031

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.

Results Reference

derived

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

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