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Tocilizumab in COVID-19 Lahore General Hospital (TC19LGH)

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ClinicalTrials.gov Identifier: NCT04560205
Recruitment Status : Recruiting
First Posted : September 23, 2020
Last Update Posted : December 8, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. M.Irfan Malik, Lahore General Hospital

Tracking Information
First Submitted Date  ICMJE July 11, 2020
First Posted Date  ICMJE September 23, 2020
Last Update Posted Date December 8, 2020
Actual Study Start Date  ICMJE May 1, 2020
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2020)
Clinical response after administration [ Time Frame: 10 days ]
Clinical improvement of COVID-19 patients by Tocillzumab The number of intubated patients. The number of patients with death.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2020)
  • Clinical response to treatment [ Time Frame: 15 days ]
    Overall survival of COVID-19 patients after drug administration.
  • Duration of hospitalization [ Time Frame: 15 days ]
    Number of days of hospital admission either in ICU or HDUs till date of discharge
  • Clinical outcome of the treatment [ Time Frame: 15 days ]
    Mortality rate
  • Supplemental Oxygen Requirement from Baseline [ Time Frame: 15 days ]
    Duration of increased supplemental oxygen requirement from baseline
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tocilizumab in COVID-19 Lahore General Hospital
Official Title  ICMJE Tocilizumab: A Therapeutic Cache Against the Treatment of Severe Cases of COVID-19
Brief Summary The most accepted description of severe COVID-19 disease is development and over production of pro-inflammatory cytokines. Autopsy studies have been done on COVID-19 patients proved that severe disease is resulted due to deviant host-immune response and cytokine storm. Elevated inflammatory biomarkers like C-Reactive protein (CRP) and pro-inflammatory cytokines shown to be higher in severe disease of COVID-19. Several studies on severe COVID-19 have revealed raised levels of plasma cytokines like IL-6, IL-2, IL-10, Gamma interferon (INF), Tumor necrosis factor Alpha TNF. The Cytokines release syndrome (CRS) is a hyperinflammatory deadly syndrome characterized by release of uncontrolled immune system activation which is responsible for multi-organ failure. It has the main role in ARDS due to SARS-CoV-2 virus which binds to alveolar epithelium and resulting in IL-6 release that is responsible for increase alveolar-epithelium permeability. In many studies it has been observed that IL-6 have played a main role in CRS induction. Previous experiences from hyperinflammatory and cytokine storm syndromes recommends that early involvement of inhibiting CRS is essential to prevent lethal tissue damage and poor clinical outcome. In this scenario the judgement of clinical specialist who are suggesting that evidence of CRS can be cured with glucocorticoids, I/V immunoglobulin and anti-cytokine therapy cannot be ignored.
Detailed Description This is intervention single-center study, that will be done at Lahore General Hospital in which 95 beds are allocated for COVID-19 patients including ICUs and HDUs. Ethical approval will be obtained from research ethical committee of Lahore General hospital, Lahore. Informed consent will be obtained from all patients who will agree to publish their data in this research. Patient's privacy and obey will be protected with the Helsinki Declaration.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
quasi-experimental
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE SARS-CoV Infection
Intervention  ICMJE Drug: Tocilizumab

4-8mg/kg with 400mg maximum dose of Tocilizumab will be given in 60 minutes I/V infusion, and dose will be repeated after 12-24 hours according to clinical as well as laboratory parameters.

Customized decision for Tocilizumab usage will be made by attending infectious diseases physician, comfort with Tocilizumab usage, bacterial co-infection and duration of Ventilation.

Other Name: ACTEMRA®
Study Arms  ICMJE Experimental: Group intervene with Tocilizumab

Review effect of Tocilizumab as clinical trial among hospitalized patients with COVID-19 infection.

Participants with severe disease will receive an intravenous (IV) injection of 8 mg/kg (not to exceed 800 mg) tocilizumab. Specifically, we will test whether tocilizumab is associated with a reduction in multi-organ dysfunction among hospitalized COVID-19 adult patients with elevated inflammatory biomarkers.

Intervention: Drug: Tocilizumab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 22, 2020)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2020
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All patients of all ages, males and non-pregnant females who will be diagnosed COVID-19 positive by RT-PCR.
  • Patients having classical radiological lesions of COVID-19 on X-ray chest or HRCT chest.
  • Patient >55 years of age Or Age <55 with comorbid condition who will be unable to maintain O2 sat > 93% with 5-7 liter of oxygen.
  • Or Patient < 55 with no comorbid conditions, who will be unable to maintain O2 sat > 93% with 7-10 liter of oxygen.
  • Respiratory rate > 30-35/ min and >50% of radiological involvement of lung with typical lesions.
  • Along with > 50% deranged ≥ 2 biochemical markers CRP > 50 mg/l, LDH > 1000U/L, D.Dimer > 1mg/l or 1000 ng/ml, Serum Ferritin > 1000 ng/ml or mcg/l will be included in clinical trial.

Exclusion Criteria:

  • Patient who will not require supplemental oxygen during hospital stay.
  • Patients on Invasive mechanical ventilation (IMV).
  • Patients with respiratory rate < 30/mins and whose laboratory findings will not be deranged > 50%.
  • Patients with improving radiological findings will be excluded.
  • Patients suffering from Active TB
  • Herpes zoster
  • Multiple sclerosis,
  • Allergic to tocilizumab
  • Presences of chronic renal failure > 4 stage, GFR < 30ml/min/1.73m2.
  • ALT/AST > 5 times than normal values.
  • Presences of neutropenia < 500/mm3.
  • Platelets count less than 50 ×103 /µl.
  • Complicated diverticulitis/ intestinal perforation.
  • Immune-suppressive anti- rejection therapy.
  • Pregnant women.
  • Previous MI/ IHD, IV heart failure.
  • Psychiatric patients.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Muhammad Irfan Malik 03334367220 drmirfanmalik@hotmail.com
Listed Location Countries  ICMJE Pakistan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04560205
Other Study ID Numbers  ICMJE LGH001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. M.Irfan Malik, Lahore General Hospital
Study Sponsor  ICMJE Lahore General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sardar Al-Fareed Zafar Post-Graduate Medical Institute, Lahore General Hospital, Lahore Pakistan
PRS Account Lahore General Hospital
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP