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Tocilizumab in COVID-19 Lahore General Hospital (TC19LGH)

Primary Purpose

SARS-CoV Infection

Status

Unknown status

Phase

Phase 1

Locations

Pakistan

Study Type

Interventional

Intervention

Tocilizumab

About this trial

This is an interventional treatment trial for SARS-CoV Infection focused on measuring COVID-19, IL-6 Inhibitor

Eligibility Criteria

15 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Lahore General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Group intervene with Tocilizumab

Arm Description

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.

Outcomes

Primary Outcome Measures

Clinical response after administration

Clinical improvement of COVID-19 patients by Tocillzumab The number of intubated patients. The number of patients with death.

Secondary Outcome Measures

Clinical response to treatment

Overall survival of COVID-19 patients after drug administration.

Duration of hospitalization

Number of days of hospital admission either in ICU or HDUs till date of discharge

Clinical outcome of the treatment

Mortality rate

Supplemental Oxygen Requirement from Baseline

Duration of increased supplemental oxygen requirement from baseline

Full Information

NCT ID

NCT04560205

First Posted

July 11, 2020

Last Updated

December 4, 2020

Sponsor

Lahore General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04560205

Brief Title

Tocilizumab in COVID-19 Lahore General Hospital

Acronym

TC19LGH

Official Title

Tocilizumab: A Therapeutic Cache Against the Treatment of Severe Cases of COVID-19

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Unknown status

Study Start Date

May 1, 2020 (Actual)

Primary Completion Date

December 30, 2020 (Anticipated)

Study Completion Date

December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Lahore General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

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

SARS-CoV Infection

Keywords

COVID-19, IL-6 Inhibitor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Model Description

quasi-experimental

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group intervene with Tocilizumab

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Tocilizumab

Other Intervention Name(s)

ACTEMRA®

Intervention Description

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.

Primary Outcome Measure Information:

Title

Clinical response after administration

Description

Clinical improvement of COVID-19 patients by Tocillzumab The number of intubated patients. The number of patients with death.

Time Frame

10 days

Secondary Outcome Measure Information:

Title

Clinical response to treatment

Description

Overall survival of COVID-19 patients after drug administration.

Time Frame

15 days

Title

Duration of hospitalization

Description

Number of days of hospital admission either in ICU or HDUs till date of discharge

Time Frame

15 days

Title

Clinical outcome of the treatment

Description

Mortality rate

Time Frame

15 days

Title

Supplemental Oxygen Requirement from Baseline

Description

Duration of increased supplemental oxygen requirement from baseline

Time Frame

15 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Muhammad Irfan Malik

Phone

03334367220

drmirfanmalik@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sardar Al-Fareed Zafar

Organizational Affiliation

Post-Graduate Medical Institute, Lahore General Hospital, Lahore Pakistan

Official's Role

Study Director

Facility Information:

Facility Name

Lahore General Hospital

City

Lahore

State/Province

Punjab

ZIP/Postal Code

54500

Country

Pakistan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Muhammad Irfan malik

Phone

03334367220

drmirfanmalik@hotmail.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

32374815

Citation

Wichmann D, Sperhake JP, Lutgehetmann M, Steurer S, Edler C, Heinemann A, Heinrich F, Mushumba H, Kniep I, Schroder AS, Burdelski C, de Heer G, Nierhaus A, Frings D, Pfefferle S, Becker H, Bredereke-Wiedling H, de Weerth A, Paschen HR, Sheikhzadeh-Eggers S, Stang A, Schmiedel S, Bokemeyer C, Addo MM, Aepfelbacher M, Puschel K, Kluge S. Autopsy Findings and Venous Thromboembolism in Patients With COVID-19: A Prospective Cohort Study. Ann Intern Med. 2020 Aug 18;173(4):268-277. doi: 10.7326/M20-2003. Epub 2020 May 6.

Results Reference

background

PubMed Identifier

24290661

Citation

Ramos-Casals M, Brito-Zeron P, Lopez-Guillermo A, Khamashta MA, Bosch X. Adult haemophagocytic syndrome. Lancet. 2014 Apr 26;383(9927):1503-1516. doi: 10.1016/S0140-6736(13)61048-X. Epub 2013 Nov 27. Erratum In: Lancet. 2014 Apr 26;383(9927):1464.

Results Reference

background

PubMed Identifier

32343968

Citation

Radbel J, Narayanan N, Bhatt PJ. Use of Tocilizumab for COVID-19-Induced Cytokine Release Syndrome: A Cautionary Case Report. Chest. 2020 Jul;158(1):e15-e19. doi: 10.1016/j.chest.2020.04.024. Epub 2020 Apr 25.

Results Reference

background

PubMed Identifier

32291137

Citation

Liu B, Li M, Zhou Z, Guan X, Xiang Y. Can we use interleukin-6 (IL-6) blockade for coronavirus disease 2019 (COVID-19)-induced cytokine release syndrome (CRS)? J Autoimmun. 2020 Jul;111:102452. doi: 10.1016/j.jaut.2020.102452. Epub 2020 Apr 10.

Results Reference

background

PubMed Identifier

32293098

Citation

Henderson LA, Canna SW, Schulert GS, Volpi S, Lee PY, Kernan KF, Caricchio R, Mahmud S, Hazen MM, Halyabar O, Hoyt KJ, Han J, Grom AA, Gattorno M, Ravelli A, De Benedetti F, Behrens EM, Cron RQ, Nigrovic PA. On the Alert for Cytokine Storm: Immunopathology in COVID-19. Arthritis Rheumatol. 2020 Jul;72(7):1059-1063. doi: 10.1002/art.41285. Epub 2020 May 10.

Results Reference

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Tocilizumab in COVID-19 Lahore General Hospital

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