Cyclosporine For The Treatment Of COVID-19(+)
Condition: SARS (Disease)
MeSH terms: COVID-19
Intervention: Cyclosporine; Standard of Care Treatment
Intervention description: 2.5 mg/kg PO BID 7 days; Standard of Care Treatment, N= 25 Patients, 7 days
Intervention MeSH terms: Cyclosporine; Cyclosporins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase IIa clinical trial in which 75 non-ICU hospital inpatients will be randomized 2:1 to 7 days of Neoral (2.5mg/kg PO BID) + standard of care (SOC) or no CSA + SOC.
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: COVID-19; SARS-COV-2; Corona Virus

Summary:

      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) + 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.
    

Eligibility criteria:

        Inclusion Criteria:

        3.1.1 Laboratory-confirmed SARS-CoV-2 infection within the past 10 days.

        3.1.2 Patients admitted to non-ICU hospital floors or in an emergency department awaiting
        admission to a non-ICU hospital bed.

        3.1.3 WHO COVID Scale Score 4 (Oxygen by mask or nasal prongs or WHO COVID Scale Score 5
        (non-invasive ventilation or high-flow oxygen).

        3.1.4 Age 18 to 90 years old.

        3.1.5 ECOG (Eastern Cooperative Oncology Group) performance status ≤2 (see Appendix A).

        3.1.6 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.

        3.1.7 Ability to understand and the willingness to sign a written informed consent
        document.

        Exclusion Criteria:

        3.2.1 Allergy and/or hypersensitivity to CSA.

        3.2.2 GFR<30 mL/min.

        3.2.3 ALT (Alanine transaminase) or AST (Aspartate transaminase) >3X upper limits of
        normal.

        3.2.4 Resistant hypertension (BP>140/90 mm Hg despite adherence to maximal doses of three
        antihypertensive agents).

        3.2.5 Active bacterial or mycobacterial infection.

        3.2.6 Pregnant and/or nursing patients. 3.2.7 Participation in a COVID-19 therapeutic drug
        trial.

        3.2.8 Patients who have received or who are receiving anti-viral medications including
        hydroxychloroquine will not be excluded.

        3.2.9 Patients with psychiatric illness/social situations that would limit compliance with
        study requirements.

        3.2.10 Total cholesterol is < 100 (increased risk of seizure)

        3.2.11 Concomitant dosing with Tacrolimus is a relative contraindication (increases overall
        immunosuppression and decrease seizure threshold

        3.2.12 Concomitant malignancy is a relative contraindication (Neoral can increase
        susceptibility to development of neoplasia)

        3.2.13 Inability to swallow oral medication

        3.2.14 Treatment with immunomodulators or immunosuppressant drugs, including but not
        limited to IL-6 inhibitors, TNF inhibitors, anti-IL-1 agents, and JAK inhibitors.

        3.2.15 Investigational Antiviral agents