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

April 11, 2020 updated by: University of Malaya

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

310

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Adeeba Kamarulzaman, MBBS
  • Phone Number: +603-79492050
  • Email: adeeba@um.edu.my

Study Contact Backup

Study Locations

  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportion of patients requiring mechanical ventilation
Time Frame: Through study completion, and average of 6 months
Through study completion, and average of 6 months
Mean days of ventilation
Time Frame: Through study completion, and average of 6 months
Through study completion, and average of 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The proportion of patients requiring ICU admission
Time Frame: Through study completion, and average of 6 months
Through study completion, and average of 6 months
Overall 28-day survival
Time Frame: 28 day from baseline
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
7 days from baseline
Duration of hospital and ICU stay
Time Frame: Through study completion, and average of 6 months
Through study completion, and average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

April 15, 2020

Primary Completion (ANTICIPATED)

October 31, 2020

Study Completion (ANTICIPATED)

October 31, 2020

Study Registration Dates

First Submitted

April 8, 2020

First Submitted That Met QC Criteria

April 11, 2020

First Posted (ACTUAL)

April 14, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 14, 2020

Last Update Submitted That Met QC Criteria

April 11, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TVCS-COVID19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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