Cyclosporine For The Treatment Of COVID-19(+)
SARS (Disease)
About this trial
This is an interventional treatment trial for SARS (Disease) focused on measuring COVID-19, SARS-COV-2, Corona Virus
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
Sites / Locations
- Baylor College of Medicine
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Arm A Cyclosporine
Arm B Standard of Care
Neoral, N=50 Patients 2.5 mg/kg PO BID 7 days
Standard of Care Treatment, N= 25 Patients 7 days