NCT04321993Active, not recruitingPhase 2
Treatment of Moderate to Severe Coronavirus Disease (COVID-19) in Hospitalized Patients
Lisa Barrett1 site in 1 country363 target enrollmentStarted: April 17, 2020Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 363
- Locations
- 1
- Primary Endpoint
- Clinical status of subject at day 15 (on a 7 point ordinal scale).
Study Overview
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 to severe COVID-19 disease that meet eligibility criteria will be offered participation.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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)
Arms & Interventions
Baricitinib
Experimental
Moderate and severe, not critical disease
Intervention: Baricitinib (janus kinase inhibitor) (Drug)
Remdesivir
Experimental
Moderate and severe, not critical disease
Intervention: Remdesivir (antiviral) (Drug)
Remdesivir + baricitinib
Experimental
Moderate and severe, not critical disease
Intervention: Remdesivir (antiviral) + barictinib (janus kinase inhibitor) (Drug)
Tocilizumab
Experimental
Severe, critical disease
Intervention: Tocilizumab (interleukin 6 inhibitor) (Drug)
Outcomes
Primary Outcomes
Clinical status of subject at day 15 (on a 7 point ordinal scale).
Time Frame: Up to 15 days
1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities; 3. Hospitalized, not requiring supplemental oxygen; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 6. Hospitalized, on invasive mechanical ventilation or ECMO; 7. Death.
Secondary Outcomes
- Number of participants that developed Acute Respiratory Distress Syndrome (ARDS) after treatment(Up to 24 weeks)
- Length of time to clinical progression(Up to 29 days)
- Cause of death (if applicable)(Up to 24 weeks)
- Length of time to clinical improvement(Up to 29 days)
- Status on an ordinal scale assessed daily while hospitalized and on days 15 and 29 and 180.(Up to 180 days)
- Number of participants with normal pulmonary function and normal O2 saturation on days 11, 15 and 29(Up to 29 days)
- Duration of supplemental oxygen (if applicable)(Up to 29 days)
- Duration of mechanical ventilation (if applicable)(Up to 29 days)
- Adverse events(Up to 180 days)
- Sequential Organ Failure Assessment (SOFA) score, daily while hospitalized and on days 15 and 29. (Initial, highest, deltas and mean)(Up to 29 days)
- Length of time to normalization of fever(Up to 29 days)
- Length of time to normalization of oxygen saturation(Up to 29 days)
- Duration of hospitalization(Up to 29 days)
Investigators
Lisa Barrett
Clinician Scientist
Nova Scotia Health Authority
Study Sites (1)
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