Cyclosporine For The Treatment Of COVID-19(+)
Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY WHO(World Health Organization) COVID-19 Clinical Severity Scale |
2; 2 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT04492891). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.