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

NCT04345445 | Unknown Phase 3 DMC

• 1 other identifier: TVCS-COVID19
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

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

Keywords

COVID-19

Outcome Measures

Primary Outcomes (2)

• The proportion of patients requiring mechanical ventilation

  Through study completion, and average of 6 months

• Mean days of ventilation

  Through study completion, and average of 6 months

Secondary Outcomes (4)

• The proportion of patients requiring ICU admission

  Through study completion, and average of 6 months

• Overall 28-day survival

  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

  7 days from baseline

• Duration of hospital and ICU stay

  Through study completion, and average of 6 months

Study Arms (2)

Tocilizumab

EXPERIMENTAL

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

Drug: Tocilizumab

Methylprednisolone

ACTIVE COMPARATOR

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

Drug: Methylprednisolone

Interventions

Tocilizumab DRUG

IV infusion

Tocilizumab

Methylprednisolone DRUG

IV infusion

Methylprednisolone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.
• Hospitalised symptomatic COVID-19 patients
• 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
• Age \> 18 years and able to give consent

You may not qualify if:

• Patients will be excluded if any of the following conditions apply:
• Known sensitivity/allergy to TCZ or other monoclonal antibodies
• AST/ALT\>5 times UNL, platelet counts \<50,000 or neutrophil counts \<500
• Active TB
• Pregnant
• Receipt of mechanical ventilation
• Has received other immunomodulatory drugs (including TCZ) in the past for the treatment of other conditions
• 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.
• Participating in other clinical trials (subject to approval)
• 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.

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location

MeSH Terms

Conditions

COVID-19

Interventions

tocilizumab; Methylprednisolone

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Adeeba Kamarulzaman, MBBS

CONTACT

+603-79492050; adeeba@um.edu.my

Reena Rajasuriar, PhD

CONTACT

reena@um.edu.my

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 14, 2020
• Study Start: April 15, 2020
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: April 14, 2020

Record last verified: 2020-04

Locations

MY (1)