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Cyclosporine in Patients With Moderate COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04412785
Recruitment Status : Recruiting
First Posted : June 2, 2020
Last Update Posted : June 29, 2020
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

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 disease requiring oxygen supplementation but not requiring ventilator support.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Cyclosporine Phase 1

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 oral divided q12h or 3 mg/kg/day by continuous IV infusion. Oral administration is generally preferred, however IV administration can be used if oral administration is not feasible or cannot be tolerated, or at the physician-investigator's clinical discretion. The dose will be adjusted to target a trough level of 200 to 300 ng/ml, which is in alignment with common clinical practice. The planned duration of CSA treatment is up to 14 days, with planned discontinuation upon discharge from the hospital. Dose reduction of 25% to 50% can be made for patients who experience adverse events such as hypertension or serum creatinine elevation.

The end of study will be study day 30 for those patients who have been discharged from the hospital. If the patient remains in the hospital, the subject will still complete the end of study visit at day 30 as planned, but will continue to be followed until date of discharge.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Trial for the Prevention of Cytokine Release Syndrome (CRS) With Cyclosporine in Patients With Moderate COVID-19
Actual Study Start Date : June 22, 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single Arm
Cyclosporine; oral or IV route of administration, per investigator discretion. Duration of administration up to 14 days, as tolerated.
Drug: Cyclosporine
• The initial dose will be 9 mg/kg/day oral divided q12h. For IV, the dose will be 3mg/kg/day by continuous IV infusion.
Other Name: Sandimmune, Neoral, Gengraf




Primary Outcome Measures :
  1. Safety-oxygen, ICU transfer and ventilation [ Time Frame: 3 months ]
    Safety will be measured: By assessing the proportion of participants requiring increase in oxygen requirements, transfer to intensive care unit, and/or mechanical ventilation

  2. Safety-changes in absolute lymphocyte count [ Time Frame: 3 months ]
    Safety will be assessed: By monitoring changes in absolute lymphocyte counts

  3. Safety-changes in creatinine clearance [ Time Frame: 3 months ]
    Safety will be assessed: By monitoring changes in creatinine clearance. Creatinine clearance will be estimated using the Cockcroft-Gault formula.

  4. Safety-secondary bacterial infections [ Time Frame: 3 months ]
    Safety will be assessed: By monitoring the incidence of secondary bacterial infections complicating COVID-19 hospitalization


Secondary Outcome Measures :
  1. Laboratory measurements of safety and antiviral efficacy related to COVID-19-SARS-CoV-2 by measuring the clearance of SARS-CoV-2 from respiratory secretions [ Time Frame: 3 months ]
    To measure time to SARS-CoV-2 clearance (PCR negativity) at Days 7 and 14 by deep nasal swab

  2. Laboratory measurements-D-dimer levels [ Time Frame: 3 months ]
    To measure the laboratory correlatives of CRS/ Hemophagocytic lymphohistiocytosis (HLH) by measuring: D-dimer levels

  3. Laboratory measurements-ferritin [ Time Frame: 3 months ]
    To measure the laboratory correlatives of CRS/ Hemophagocytic lymphohistiocytosis (HLH) by measuring: ferritin levels

  4. Laboratory measurements- IL-6 [ Time Frame: 3 months ]
    To measure the laboratory correlatives of CRS/ Hemophagocytic lymphohistiocytosis (HLH) by measuring: IL-6 levels



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04412785


Contacts
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Contact: Joan Gilmore 215-746-8902 jgilmore@pennmedicine.upenn.edu
Contact: Karen Dengel, RN dkaren@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Joan Gilmore    215-746-8902    jgilmore@pennmedicine.upenn.edu   
Contact: Karen Dengel, RN       dkaren@pennmedicine.upenn.edu   
Principal Investigator: Emily Blumberg, MD         
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Emily Blumberg, MD University of Pennsylvania
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04412785    
Other Study ID Numbers: 842998
First Posted: June 2, 2020    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Cyclosporine
Cyclosporins
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors