COVID-19Phase 3NCT04345445
Study to Evaluate the Efficacy and Safety of Tocilizumab Versus Corticosteroids in Hospitalised COVID-19 Patients With High Risk of Progression
A Phase 3 study testing Tocilizumab and Methylprednisolone in people with COVID-19, run by University of Malaya at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Tocilizumab and Methylprednisolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteMalaysia
- Study dates
- 15 Apr 2020to 31 Oct 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Reena Rajasuriar, PhD contact
Malaysia1 site
University Malaya Medical Centre
Kuala Lumpur, 59100
Reena Rajasuriar, PhD, reena@um.edu.my
Adeeba Kamarulzaman, MBBS
About this study
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
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
- Being tested
- Tocilizumab, Methylprednisolone
- Keywords
- COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocilizumabDrug
IV infusion
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Tocilizumab | Experimental | Tocilizumab is given at 8 mg/kg (body weight) once and administered as an intravenous infusion within no less than 60 minutes. Receives: Drug: Tocilizumab |
| Methylprednisolone | Active comparator | Reconstituted methylprednisolone is infused over 30 minutes and administered at a dose of 120mg/day for 3 days Receives: Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients requiring mechanical ventilation
Measured: Through study completion, and average of 6 months
Mean days of ventilation
Measured: Through study completion, and average of 6 months
Secondary outcomes (4)
The proportion of patients requiring ICU admission
Measured: Through study completion, and average of 6 months
Overall 28-day survival
Measured: 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
Measured: 7 days from baseline
Duration of hospital and ICU stay
Measured: Through study completion, and average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start15 Apr 2020 (estimated)
- Primary completion31 Oct 2020 (estimated)
- Study completion31 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04345445
- Sponsor's protocol ID
- TVCS-COVID19
- Status last verified
- Apr 2020
- First submitted
- 8 Apr 2020
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04345445
- Acronym / sponsor ID
- TVCS-COVID19
- Conditions
- COVID-19
- Keywords
- COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 15 Apr 2020 (estimated)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 31 Oct 2020 (estimated)
- First posted
- 14 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tocilizumab | Experimental | Drug: TocilizumabTocilizumab is given at 8 mg/kg (body weight) once and administered as an intravenous infusion within no less than 60 minutes. |
| Methylprednisolone | Active comparator | Drug: MethylprednisoloneReconstituted methylprednisolone is infused over 30 minutes and administered at a dose of 120mg/day for 3 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TocilizumabIV infusion | Drug | Tocilizumab |
| MethylprednisoloneIV infusion | Drug | Methylprednisolone |
Primary outcome
The proportion of patients requiring mechanical ventilation
Time frame: Through study completion, and average of 6 months
Mean days of ventilation
Time frame: Through study completion, and average of 6 months
4 secondary outcomes
The proportion of patients requiring ICU admission
Time frame: Through study completion, and average of 6 months
Overall 28-day survival
Time frame: 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
Duration of hospital and ICU stay
Time frame: Through study completion, and average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reena Rajasuriar, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tocilizumab and Methylprednisolone in people with COVID-19, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adeeba Kamarulzaman, MBBS (+603-79492050, adeeba@um.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients requiring mechanical ventilation (time frame: Through study completion, and average of 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.