Randomized Phase IIa Clinical Trial Of Cyclosporine For The Treatment Of COVID-19(+) Non-ICU Hospital Inpatients (H-48163)

Design

Phase IIa clinical trial in which 75 non-ICU hospital inpatients will be randomized 2:1 to 7 days of an oral formulation of cyclosporine, Neoral  (2.5mg/kg PO BID) and standard of care (SOC) or no Neoral + SOC. 

The primary endpoint is disease severity based on the World Health Organization (WHO) COVID Ordinal Outcomes Scale, on day 14. Secondary endpoints include safety and changes in serum inflammatory markers.  

Primary Objectives

• To assess the effect of a 7-day course of oral cyclosporine (Neoral) on clinical outcome using the World Health Organization (WHO) COVID Ordinal Clinical Outcomes Scale, on day 14. 

Eligibility

• Laboratory-confirmed SARS-CoV-2 infection within the past 10 days.
• Patients admitted to non-ICU hospital floors or in an emergency department awaiting admission to a non-ICU hospital bed.
• WHO COVID Scale Score 4 (Oxygen by mask or nasal prongs) or WHO COVID Scale Score 5 (non-invasive ventilation or high-flow oxygen)
• Age 18 to 90 years old.
• ECOG performance status ≤2.
• Patients receiving or who have received standard of care therapy for COVID-19 can be included. This includes Remdesivir, Dexamethasone (or other steroids) and convalescent plasma. 
• Ability to understand and the willingness to sign a written informed consent document.