Cyclosporine For The Treatment Of COVID-19(+)

• Status: Recruiting
• Trial end date: 2025-11-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bryan Burt, MD
• Collaborator: Brigham and Women's Hospital
• Treatments: Cyclosporine; Cyclosporins

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