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Study to Evaluate the Efficacy and Safety of Tocilizumab Versus Corticosteroids in Hospitalised COVID-19 Patients With High Risk of Progression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04345445
Recruitment Status : Unknown
Verified April 2020 by University of Malaya.
Recruitment status was:  Not yet recruiting
First Posted : April 14, 2020
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
University of Malaya

Study Description
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Brief Summary:

This study aims to compare the efficacy and safety of Methylprednisolone versus Tocilizumab in improving clinical outcomes and reducing the need for ventilator support in COVID-19 patients with moderate COVID-19 disease at risk for complications of cytokine storm. Approximately 310 participants hospitalized with COVID-19 in UMMC, Hospital Sungai Buloh, Hospital Kuala Lumpur and Hospital Tuanku Jaafar will be enrolled into this study.

Eligible participants will be selected based on a set of clinical, laboratory and radiological parameters indicative of early stages of CRS and lung function decline prior to being randomized at a ratio of 1:1 to receive either Tocilizumab or Methylprednisolone. Participants will be monitored daily for clinical and laboratory parameters, and at 48 hours, switched to the alternate study arm should they manifest signs and symptoms indicative of decompensation.


Condition or disease Intervention/treatment Phase
COVID-19 Drug: Tocilizumab Drug: Methylprednisolone Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 310 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Cross-over Interventional Study to Evaluate the Efficacy and Safety of Tocilizumab Versus Corticosteroids in Hospitalised COVID-19 Patients With High Risk of Progression
Estimated Study Start Date : April 15, 2020
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Tocilizumab
Tocilizumab is given at 8 mg/kg (body weight) once and administered as an intravenous infusion within no less than 60 minutes.
 Drug: Tocilizumab
IV infusion
Active Comparator: Methylprednisolone
Reconstituted methylprednisolone is infused over 30 minutes and administered at a dose of 120mg/day for 3 days
 Drug: Methylprednisolone
IV infusion


Outcome Measures
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Primary Outcome Measures :
  1. The proportion of patients requiring mechanical ventilation [ Time Frame: Through study completion, and average of 6 months ]
  2. Mean days of ventilation [ Time Frame: Through study completion, and average of 6 months ]

Secondary Outcome Measures :
  1. The proportion of patients requiring ICU admission [ Time Frame: Through study completion, and average of 6 months ]
  2. Overall 28-day survival [ Time Frame: 28 day from baseline ]
  3. Change in symptom severity assessed by the World Health Organization (WHO) Coronavirus Disease 2019 (COVID19) ordinal scale measured daily up to 7 days from baseline [ Time Frame: 7 days from baseline ]
  4. Duration of hospital and ICU stay [ Time Frame: Through study completion, and average of 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1) Hospitalised symptomatic COVID-19 patients 2( Presence of clinical and radiological signs of progressive disease, AND laboratory evidence indicative of risk for cytokine storm complications.

All patients participating in this clinical trial must meet the following inclusion criteria:

  1. Hospitalised symptomatic COVID-19 patients

  2. Presence of clinical and radiological signs of progressive disease, AND laboratory evidence indicative of risk for cytokine storm complications:

    Clinical:

    Dyspnoea OR RR>20 breaths/min AND O2 sat <93% on RA OR increasing need for O2 supplementation to maintain O2 sat >95% on RA

    WITH

    Radiological:

    CXR or CT indicative of pneumonia OR worsening findings over time

    AND

    Laboratory:

    CRP levels >60 OR an increase of CRP >20 over 12 hours WITH an increasing ferritin level OR declining lymphocyte counts

  3. Age > 18 years and able to give consent

Exclusion Criteria:

Patients will be excluded if any of the following conditions apply:

  1. Known sensitivity/allergy to TCZ or other monoclonal antibodies
  2. AST/ALT>5 times UNL, platelet counts <50,000 or neutrophil counts <500
  3. Active TB
  4. Pregnant
  5. Receipt of mechanical ventilation
  6. Has received other immunomodulatory drugs (including TCZ) in the past for the treatment of other conditions
  7. Individuals, in the opinion of the investigator, where progression to death is imminent and inevitable in the next 24 hours irrespective of treatment provision or who have signed a DNR.
  8. Participating in other clinical trials (subject to approval)
  9. Any serious medical condition or abnormal clinical laboratory tests which in the judgement of the investigator may compromise patient safety should he/she participate in the study.
Contacts and Locations
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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): NCT04345445


Contacts
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Contact: Adeeba Kamarulzaman, MBBS +603-79492050 adeeba@um.edu.my
Contact: Reena Rajasuriar, PhD reena@um.edu.my

Locations
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Malaysia
University Malaya Medical Centre
Kuala Lumpur, Malaysia, 59100
Contact: Reena Rajasuriar, PhD       reena@um.edu.my   
Principal Investigator: Adeeba Kamarulzaman, MBBS         
Sub-Investigator: Sharifah Faridah Syed Omar, MBBS         
Sub-Investigator: Reena Rajasuriar, PhD         
Principal Investigator: Suresh Kumar Chidambaram, MBBS         
Principal Investigator: Tiang Koi Ng, MBBS         
Principal Investigator: Chee Loon Leong, MBBS         
Sponsors and Collaborators
University of Malaya
More Information
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Responsible Party: University of Malaya
ClinicalTrials.gov Identifier: NCT04345445    
Other Study ID Numbers: TVCS-COVID19
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 University of Malaya:
COVID-19
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
 Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents