Overview

Cyclosporine in Patients With Moderate COVID-19

Status:
Active, not recruiting

Trial end date:
2021-12-01

Target enrollment:
0

Participant gender:
All

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 disease requiring oxygen supplementation but not requiring ventilator support.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Pennsylvania

Treatments:

Cyclosporine
Cyclosporins

Criteria

Inclusion Criteria:

1. Provision of signed and dated informed consent form

2. Stated willingness to comply with all study procedures and availability for the
duration of the study

3. Male or female, aged >18.

4. Admitted to hospital with laboratory confirmation of SARS-CoV-2 infection.

5. Estimated creatinine clearance >50 ml/min using standard Cockcroft-Gault formula.

Exclusion Criteria:

1. Are admitted to the ICU at time of enrollment.

2. Have an active uncontrolled infection with a non-COVID-19 agent.

3. Have an active malignancy, not including non-melanoma skin cancer, superficial
cervical or bladder cancer, MGUS, or prostate cancer with PSA <1.0.

4. Are on chronic immune suppressive medications, including

5. corticosteroid therapy at a prednisone equivalent dose of 10 mg per day or higher;
therapy with calcineurin inhibitors or mTOR inhibitors.

6. Are pregnant

7. Are lactating

8. Have a known allergic reaction to components of the CSA or its diluents.

9. Are receiving investigational vaccine for SARS-CoV-2.