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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years or older
Moderate to severe COVID-19 associated disease as defined by the WHO
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 180 days
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Summary
This trial will test if an investigational medication is safe and effective when used alongside the clinical standard of care treatment for people hospitalized with moderate to severe COVID-19 disease.
Who is the study for?
This trial is for hospitalized adults with moderate to severe COVID-19, confirmed by a test. Participants must have lung issues or need oxygen support but can't join if they have certain liver problems, untreated TB, active hepatitis B/C, recent serious infections, are pregnant/breastfeeding, or have severe kidney disease.
What is being tested?
The study tests Tocilizumab (blocks inflammation), Remdesivir (antiviral) alone or with Baricitinib (reduces immune response), alongside standard care. It aims to see how well these treatments work and their safety in different severity levels of COVID-19 patients.
What are the potential side effects?
Possible side effects include allergic reactions to the drugs; increased risk of infection; liver enzyme elevations; potential heart rhythm problems from Baricitinib; and infusion-related reactions from Tocilizumab.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have moderate to severe COVID-19 according to WHO standards.
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My condition requires oxygen but not ICU-level care, or I need ICU care due to severe symptoms.
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My potassium, magnesium, and calcium levels are normal before starting treatment.
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I have lung issues, need oxygen, or am on a ventilator.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 180 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 180 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinical status of subject at day 15 (on a 7 point ordinal scale).
Secondary study objectives
Length of time to clinical improvement
Length of time to clinical progression
Length of time to normalization of fever
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: TocilizumabExperimental Treatment1 Intervention
Severe, critical disease
Group II: Remdesivir + baricitinibExperimental Treatment1 Intervention
Moderate and severe, not critical disease
Group III: RemdesivirExperimental Treatment1 Intervention
Moderate and severe, not critical disease
Group IV: BaricitinibExperimental Treatment1 Intervention
Moderate and severe, not critical disease
Group V: Clinical standard of careActive Control1 Intervention
Moderate and severe, not critical disease AND severe, critical disease as applicable
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Who is running the clinical trial?
Dalhousie UniversityOTHER
173 Previous Clinical Trials
401,491 Total Patients Enrolled
Lisa BarrettLead Sponsor
2 Previous Clinical Trials
74 Total Patients Enrolled
Nova Scotia Health AuthorityOTHER
288 Previous Clinical Trials
94,199 Total Patients Enrolled
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