Status:
UNKNOWN
Treatment of Moderate to Severe Coronavirus Disease (COVID-19) in Hospitalized Patients
Lead Sponsor:
Lisa Barrett
Collaborating Sponsors:
Nova Scotia Health Authority
Dalhousie University
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Investigational medications adjunct to clinical standard of care treatment will be assessed to evaluate safety and effectiveness as an anti-COVID-19 treatment. All hospitalized persons with moderate t...
Eligibility Criteria
Inclusion
- 18 years or older
- Moderate to severe COVID-19 associated disease as defined by the WHO
- Willing and able to provide informed consent prior to performing study procedures
- Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay
- Illness of any duration, and at least one of the following: Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), or Clinical assessment (evidence of rales/crackles on exam) AND SpO2 ≤ 94% on room air, or Require mechanical ventilation and/or supplemental oxygen.
- Normal potassium, magnesium, and calcium levels pre-therapy when used in agents at risk of QT prolongation
- Patients will be further distinguished based on their disease severity into one of two categories:
- Moderate and severe, not critical disease: patients with SpO2 ≤ 94% on room air, and those who require supplemental oxygen
- Severe, critical disease: patients with critical illness requiring ICU-level care including requiring mechanical ventilation or ECMO, and/or end organ dysfunction as seen in sepsis/septic shock.
Exclusion
- Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 X upper limit of normal (ULN)
- Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study treatment Medication specific Exclusion
- Baricitinib:
- Contraindicated for patients with known hypersensitivity to baricitinib or to any of the excipients.
- Prior untreated latent tuberculosis
- Any individuals with TB risk factors will not be enrolled in the baricitinib arm of the study.
- Presence of active viral hepatitis C or B
- People with a clinical history of invasive or active fungal infection
- People with a clinical history of active CMV disease in the last year
- Patients who are pregnant or breastfeeding
- Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR \<15)
- Tocilizumab:
- Known hypersensitivity to tocilizumab or any of its components
- Prior untreated latent tuberculosis
- Any individuals with TB risk factors will not be enrolled in the tocilizumab arm of the study.
- Presence of active viral hepatitis C or B
- People with a clinical history of invasive or active fungal infection
- People with a clinical history of active CMV disease in the last year
- CRP\<75 mg/L
- SpO2 ≥ 92% on room air
- Remdesivir:
- Known hypersensitivity to remdesivir or any of its components
- Weight below 40 kg
- SpO2 ≥ 94% on room air
- Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR \<30)
Key Trial Info
Start Date :
April 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2024
Estimated Enrollment :
363 Patients enrolled
Trial Details
Trial ID
NCT04321993
Start Date
April 17 2020
End Date
April 1 2024
Last Update
September 18 2023
Active Locations (1)
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1
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada, B3H 1V7