Status:
COMPLETED
Cyclosporine in Patients With Moderate COVID-19
Lead Sponsor:
University of Pennsylvania
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Phase 1 safety study to determine the tolerability, clinical effects, and changes in laboratory parameters of short course oral or IV cyclosporine (CSA) administration in patients with COVID-19 diseas...
Detailed Description
Our overall hypothesis is that CSA is safe in this patient population and that it will have antiviral and anti-cytokine effects as measured in laboratory tests. The initial dose will be 9 mg/kg/day o...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged \>18.
- Admitted to hospital with laboratory confirmation of SARS-CoV-2 infection.
- Estimated creatinine clearance \>50 ml/min using standard Cockcroft-Gault formula.
Exclusion
- Are admitted to the ICU at time of enrollment.
- Have an active uncontrolled infection with a non-COVID-19 agent.
- Have an active malignancy, not including non-melanoma skin cancer, superficial cervical or bladder cancer, MGUS, or prostate cancer with PSA \<1.0.
- Are on chronic immune suppressive medications, including
- corticosteroid therapy at a prednisone equivalent dose of 10 mg per day or higher; therapy with calcineurin inhibitors or mTOR inhibitors.
- Are pregnant
- Are lactating
- Have a known allergic reaction to components of the CSA or its diluents.
- Are receiving investigational vaccine for SARS-CoV-2.
Key Trial Info
Start Date :
June 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2021
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04412785
Start Date
June 30 2020
End Date
October 25 2021
Last Update
January 11 2022
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104