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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

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.

Condition or disease Intervention/treatment Phase
SARS-CoV Infection Drug: Tocilizumab Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: quasi-experimental
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tocilizumab: A Therapeutic Cache Against the Treatment of Severe Cases of COVID-19
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Tocilizumab

Arm Intervention/treatment
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.

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®




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Clinical response to treatment [ Time Frame: 15 days ]
    Overall survival of COVID-19 patients after drug administration.

  2. Duration of hospitalization [ Time Frame: 15 days ]
    Number of days of hospital admission either in ICU or HDUs till date of discharge

  3. Clinical outcome of the treatment [ Time Frame: 15 days ]
    Mortality rate

  4. Supplemental Oxygen Requirement from Baseline [ Time Frame: 15 days ]
    Duration of increased supplemental oxygen requirement from baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04560205


Contacts
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Contact: Muhammad Irfan Malik 03334367220 drmirfanmalik@hotmail.com

Locations
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Pakistan
Lahore General Hospital Recruiting
Lahore, Punjab, Pakistan, 54500
Contact: Muhammad Irfan malik    03334367220    drmirfanmalik@hotmail.com   
Sponsors and Collaborators
Lahore General Hospital
Investigators
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Study Director: Sardar Al-Fareed Zafar Post-Graduate Medical Institute, Lahore General Hospital, Lahore Pakistan
Publications:

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Responsible Party: Dr. M.Irfan Malik, Associate Professor of Pulmonology / Focal Person COVID-19, Lahore General Hospital
ClinicalTrials.gov Identifier: NCT04560205    
Other Study ID Numbers: LGH001
First Posted: September 23, 2020    Key Record Dates
Last Update Posted: December 8, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. M.Irfan Malik, Lahore General Hospital:
COVID-19
IL-6 Inhibitor
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases