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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

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ClinicalTrials.gov Identifier: NCT04345445
Recruitment Status : Not yet recruiting
First Posted : April 14, 2020
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
University of Malaya

Tracking Information
First Submitted Date  ICMJE April 8, 2020
First Posted Date  ICMJE April 14, 2020
Last Update Posted Date April 14, 2020
Estimated Study Start Date  ICMJE April 15, 2020
Estimated Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2020)
  • The proportion of patients requiring mechanical ventilation [ Time Frame: Through study completion, and average of 6 months ]
  • Mean days of ventilation [ Time Frame: Through study completion, and average of 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2020)
  • The proportion of patients requiring ICU admission [ Time Frame: Through study completion, and average of 6 months ]
  • Overall 28-day survival [ Time Frame: 28 day from baseline ]
  • 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 ]
  • Duration of hospital and ICU stay [ Time Frame: Through study completion, and average of 6 months ]
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 Study to Evaluate the Efficacy and Safety of Tocilizumab Versus Corticosteroids in Hospitalised COVID-19 Patients With High Risk of Progression
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Drug: Tocilizumab
    IV infusion
  • Drug: Methylprednisolone
    IV infusion
Study Arms  ICMJE
  • Experimental: Tocilizumab
    Tocilizumab is given at 8 mg/kg (body weight) once and administered as an intravenous infusion within no less than 60 minutes.
    Intervention: Drug: Tocilizumab
  • Active Comparator: Methylprednisolone
    Reconstituted methylprednisolone is infused over 30 minutes and administered at a dose of 120mg/day for 3 days
    Intervention: Drug: Methylprednisolone
Publications * Not Provided

*   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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 11, 2020)
310
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2020
Estimated Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Adeeba Kamarulzaman, MBBS +603-79492050 adeeba@um.edu.my
Contact: Reena Rajasuriar, PhD reena@um.edu.my
Listed Location Countries  ICMJE Malaysia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04345445
Other Study ID Numbers  ICMJE TVCS-COVID19
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
Plan to Share IPD: Undecided
Responsible Party University of Malaya
Study Sponsor  ICMJE University of Malaya
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Malaya
Verification Date April 2020

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