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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tocilizumab | Experimental | Tocilizumab is given at 8 mg/kg (body weight) once and administered as an intravenous infusion within no less than 60 minutes. |
|
| Methylprednisolone | Active Comparator | Reconstituted methylprednisolone is infused over 30 minutes and administered at a dose of 120mg/day for 3 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocilizumab | Drug | IV infusion |
| |
| Methylprednisolone |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
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
Exclusion Criteria:
Patients will be excluded if any of the following conditions apply:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adeeba Kamarulzaman, MBBS | Contact | +603-79492050 | adeeba@um.edu.my | |
| Reena Rajasuriar, PhD | Contact | reena@um.edu.my |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Malaya Medical Centre | Kuala Lumpur | 59100 | Malaysia |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C502936 | tocilizumab |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| Drug |
IV infusion |
|
| 7 days from baseline |
| Duration of hospital and ICU stay | Through study completion, and average of 6 months |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |