Status:
COMPLETED
Cyclosporine For The Treatment Of COVID-19(+)
Lead Sponsor:
Bryan Burt, MD
Collaborating Sponsors:
Brigham and Women's Hospital
Conditions:
SARS (Disease)
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief 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...
Detailed Description
1. OBJECTIVES 1.1 Primary Objectives 1.1.1 To assess the effect of a 7-day course of oral cyclosporine Neoral on clinical outcome using the World Health Organization (WHO) COVID Ordinal Clinic...
Eligibility Criteria
Inclusion
- 1.1 Laboratory-confirmed SARS-CoV-2 infection within the past 10 days.
- 1.2 Patients admitted to non-ICU hospital floors or in an emergency department awaiting admission to a non-ICU hospital bed.
- 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).
- 1.4 Age 18 to 90 years old.
- 1.5 ECOG (Eastern Cooperative Oncology Group) performance status ≤2 (see Appendix A).
- 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.
- 1.7 Ability to understand and the willingness to sign a written informed consent document.
Exclusion
- 2.1 Allergy and/or hypersensitivity to CSA.
- 2.2 GFR\<30 mL/min.
- 2.3 ALT (Alanine transaminase) or AST (Aspartate transaminase) \>3X upper limits of normal.
- 2.4 Resistant hypertension (BP\>140/90 mm Hg despite adherence to maximal doses of three antihypertensive agents).
- 2.5 Active bacterial or mycobacterial infection.
- 2.6 Pregnant and/or nursing patients. 3.2.7 Participation in a COVID-19 therapeutic drug trial.
- 2.8 Patients who have received or who are receiving anti-viral medications including hydroxychloroquine will not be excluded.
- 2.9 Patients with psychiatric illness/social situations that would limit compliance with study requirements.
- 2.10 Total cholesterol is \< 100 (increased risk of seizure)
- 2.11 Concomitant dosing with Tacrolimus is a relative contraindication (increases overall immunosuppression and decrease seizure threshold
- 2.12 Concomitant malignancy is a relative contraindication (Neoral can increase susceptibility to development of neoplasia)
- 2.13 Inability to swallow oral medication
- 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.
- 2.15 Investigational Antiviral agents
Key Trial Info
Start Date :
November 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2021
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT04492891
Start Date
November 23 2020
End Date
December 10 2021
Last Update
July 20 2023
Active Locations (1)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030