Cyclosporine For The Treatment Of COVID-19(+)

NCT04492891 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: H-48163
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS (Disease)

Keywords

COVID-19; SARS-COV-2; Corona Virus

Outcome Measures

Primary Outcomes (1)

• WHO(World Health Organization) COVID-19 Clinical Severity Scale

  WHO(World Health Organization) COVID-19 clinical severity scale. Score 0-9. 0=Uninfected, 8=Death.

  on day 14

Study Arms (2)

Arm A Cyclosporine

EXPERIMENTAL

Neoral, N=50 Patients 2.5 mg/kg PO BID 7 days

Drug: Cyclosporine

Arm B Standard of Care

OTHER

Standard of Care Treatment, N= 25 Patients 7 days

Other: Standard of Care Treatment

Interventions

Cyclosporine DRUG

2.5 mg/kg PO BID 7 days

Also known as: Neoral

Arm A Cyclosporine

Standard of Care Treatment OTHER

Standard of Care Treatment, N= 25 Patients, 7 days

Arm B Standard of Care

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Laboratory-confirmed SARS-CoV-2 infection within the past 10 days.
• Patients admitted to non-ICU hospital floors or in an emergency department awaiting admission to a non-ICU hospital bed.
• WHO COVID Scale Score 4 (Oxygen by mask or nasal prongs or WHO COVID Scale Score 5 (non-invasive ventilation or high-flow oxygen).
• Age 18 to 90 years old.
• ECOG (Eastern Cooperative Oncology Group) performance status ≤2 (see Appendix A).
• 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.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Allergy and/or hypersensitivity to CSA.
• GFR\<30 mL/min.
• ALT (Alanine transaminase) or AST (Aspartate transaminase) \>3X upper limits of normal.
• Resistant hypertension (BP\>140/90 mm Hg despite adherence to maximal doses of three antihypertensive agents).
• Active bacterial or mycobacterial infection.
• Pregnant and/or nursing patients. 3.2.7 Participation in a COVID-19 therapeutic drug trial.
• Patients who have received or who are receiving anti-viral medications including hydroxychloroquine will not be excluded.
• Patients with psychiatric illness/social situations that would limit compliance with study requirements.
• Total cholesterol is \< 100 (increased risk of seizure)
• Concomitant dosing with Tacrolimus is a relative contraindication (increases overall immunosuppression and decrease seizure threshold
• Concomitant malignancy is a relative contraindication (Neoral can increase susceptibility to development of neoplasia)
• Inability to swallow oral medication
• Treatment with immunomodulators or immunosuppressant drugs, including but not limited to IL-6 inhibitors, TNF inhibitors, anti-IL-1 agents, and JAK inhibitors.
• Investigational Antiviral agents

Sponsors & Collaborators

• Bryan Burt, MD: lead
• Brigham and Women's Hospital: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; Disease; COVID-19

Interventions

Cyclosporine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Lung Diseases

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Michelle Almarez: Clinical Research Manager
• Organization: Baylor College of Medicine

malmarez@bcm.edu

713-798-3680

Study Officials

• Bryan Burt, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Surgery General Thoracic

Model Details: 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.

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 30, 2020
• Study Start: November 23, 2020
• Primary Completion: December 10, 2021
• Study Completion: December 10, 2021
• Last Updated: July 20, 2023
• Results First Posted: July 20, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)