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