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

NCT ID: NCT04345445

Last Updated: 2020-04-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 310 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-15
• Study Completion Date: 2020-10-31

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tocilizumab

Tocilizumab is given at 8 mg/kg (body weight) once and administered as an intravenous infusion within no less than 60 minutes.

Group Type: EXPERIMENTAL

Tocilizumab

Intervention Type: DRUG

IV infusion

Methylprednisolone

Reconstituted methylprednisolone is infused over 30 minutes and administered at a dose of 120mg/day for 3 days

Group Type: ACTIVE_COMPARATOR

Methylprednisolone

Intervention Type: DRUG

IV infusion

Interventions

Tocilizumab

IV infusion

Intervention Type: DRUG

Methylprednisolone

IV infusion

Intervention Type: DRUG

Eligibility 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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Malaya

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Malaya Medical Centre

Kuala Lumpur, , Malaysia

Countries

Malaysia

Central Contacts

Adeeba Kamarulzaman, MBBS

Role: CONTACT

adeeba@um.edu.my

+603-79492050

Reena Rajasuriar, PhD

Role: CONTACT

reena@um.edu.my

Facility Contacts

Reena Rajasuriar, PhD

Role: primary

reena@um.edu.my

Other Identifiers

TVCS-COVID19

Identifier Type: -

Identifier Source: org_study_id