Treatment of Moderate to Severe Coronavirus Disease (COVID-19) in Hospitalized Patients

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lisa Barrett
• Collaborators: Dalhousie University; Nova Scotia Health Authority
• Treatments: Hydroxychloroquine; Janus Kinase Inhibitors; Lopinavir; Ritonavir

Criteria

Inclusion Criteria:

• 18 years or older

• Moderate to severe COVID-19 associated disease as defined by the WHO

• Hospitalized patient

• Willing and able to provide written 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.

• Febrile defined as temperature ≥ 36.6 °C armpit, ≥ 37.2 °C oral, or ≥ 37.8 °C rectal documented within 48 hours of consent

Exclusion Criteria:

• Participation in any other clinical trial of an experimental treatment for COVID-19

• Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 is prohibited < 24 hours prior to study medication initiation

• SOFA >10

• Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN)

• Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30)

• Pregnant women or women who are breastfeeding

• Immunocompromised patients taking medication upon screening

• Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study treatment