Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cyclosporine For The Treatment Of 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: NCT04492891
Recruitment Status : Recruiting
First Posted : July 30, 2020
Last Update Posted : November 27, 2020
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Bryan Burt, MD, Baylor College of Medicine

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 + SOC. The primary endpoint is disease severity based on the World Health Organization (WHO) COVID Ordinal Outcomes Scale, on day 14. Secondary endpoints include safety and changes in serum inflammatory markers.

Condition or disease Intervention/treatment Phase
SARS (Disease) Drug: Cyclosporine Other: Standard of Care Treatment Phase 2

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase IIa clinical trial in which 75 non-ICU hospital inpatients will be randomized 2:1 to 7 days of Neoral (2.5mg/kg PO BID) + standard of care (SOC) or no CSA + SOC.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase IIa Clinical Trial Of Cyclosporine For The Treatment Of COVID-19(+) Non-ICU Hospital Inpatients
Actual Study Start Date : November 23, 2020
Estimated Primary Completion Date : November 23, 2025
Estimated Study Completion Date : November 23, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A Cyclosporine
Neoral, N=50 Patients 2.5 mg/kg PO BID 7 days
Drug: Cyclosporine
2.5 mg/kg PO BID 7 days
Other Name: Neoral

Arm B Standard of Care
Standard of Care Treatment, N= 25 Patients 7 days
Other: Standard of Care Treatment
Standard of Care Treatment, N= 25 Patients, 7 days




Primary Outcome Measures :
  1. WHO COVID-19 clinical severity scale [ Time Frame: Through study completion, an average of 1 month. ]
    WHO COVID-19 clinical severity scale. Score 0-9. 0=Uninfected, 8=Death.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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<30 mL/min.

3.2.3 ALT (Alanine transaminase) or AST (Aspartate transaminase) >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


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): NCT04492891


Contacts
Layout table for location contacts
Contact: Michelle Almarez, BBA 713-798-3680 malmarez@bcm.edu

Locations
Layout table for location information
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Michelle Almarez, BBA    713-798-3680      
Sponsors and Collaborators
Bryan Burt, MD
Brigham and Women's Hospital
Investigators
Layout table for investigator information
Principal Investigator: Bryan Burt, MD Baylor College of Medicine
Layout table for additonal information
Responsible Party: Bryan Burt, MD, Associate Professor, Surgery General Thoracic, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT04492891    
Other Study ID Numbers: H-48163
First Posted: July 30, 2020    Key Record Dates
Last Update Posted: November 27, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bryan Burt, MD, Baylor College of Medicine:
COVID-19
SARS-COV-2
Corona Virus
Additional relevant MeSH terms:
Layout table for MeSH terms
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