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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04345445
• Other study ID #: TVCS-COVID19
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: April 15, 2020
• Est. completion date: October 31, 2020

Study information

• Verified date: April 2020
• Source: University of Malaya
• Contact: Adeeba Kamarulzaman, MBBS
• Phone: +603-79492050
• Email: adeeba[@]um.edu.my
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 310
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Disease Progression

Intervention

Drug:
• Tocilizumab
IV infusion
• Methylprednisolone
IV infusion

Locations

Country	Name	City	State
Malaysia	University Malaya Medical Centre	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients requiring mechanical ventilation		Through study completion, and average of 6 months
Primary	Mean days of ventilation		Through study completion, and average of 6 months
Secondary	The proportion of patients requiring ICU admission		Through study completion, and average of 6 months
Secondary	Overall 28-day survival		28 day from baseline
Secondary	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
Secondary	Duration of hospital and ICU stay		Through study completion, and average of 6 months