NCT04412785

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_1 covid19

Timeline
Completed

Started Jun 2020

Typical duration for phase_1 covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2020

Completed
28 days until next milestone

Study Start

First participant enrolled

June 30, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2021

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

1.3 years

First QC Date

June 1, 2020

Last Update Submit

January 7, 2022

Conditions

COVID-19

Outcome Measures

Primary Outcomes (4)

  • Safety-oxygen, ICU transfer and ventilation

    Safety will be measured: By assessing the proportion of participants requiring increase in oxygen requirements, transfer to intensive care unit, and/or mechanical ventilation

    3 months

  • Safety-changes in absolute lymphocyte count

    Safety will be assessed: By monitoring changes in absolute lymphocyte counts

    3 months

  • Safety-changes in creatinine clearance

    Safety will be assessed: By monitoring changes in creatinine clearance. Creatinine clearance will be estimated using the Cockcroft-Gault formula.

    3 months

  • Safety-secondary bacterial infections

    Safety will be assessed: By monitoring the incidence of secondary bacterial infections complicating COVID-19 hospitalization

    3 months

Secondary Outcomes (4)

  • 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

    3 months

  • Laboratory measurements-D-dimer levels

    3 months

  • Laboratory measurements-ferritin

    3 months

  • Laboratory measurements- IL-6

    3 months

Study Arms (1)

Single Arm

EXPERIMENTAL

Cyclosporine; oral or IV route of administration, per investigator discretion. Duration of administration up to 14 days, as tolerated.

Drug: Cyclosporine

Interventions

CyclosporineDRUG

• 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.

Also known as: Sandimmune, Neoral, Gengraf
Single Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Blumberg EA, Noll JH, Tebas P, Fraietta JA, Frank I, Marshall A, Chew A, Veloso EA, Carulli A, Rogal W, Gaymon AL, Schmidt AH, Barnette T, Jurek R, Martins R, Hudson BM, Chavda K, Bailey CM, Church SE, Noorchashm H, Hwang WT, June CH, Hexner EO. A phase I trial of cyclosporine for hospitalized patients with COVID-19. JCI Insight. 2022 Jun 8;7(11):e155682. doi: 10.1172/jci.insight.155682.

    PMID: 35536669DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

CyclosporineCyclosporins

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Emily Blumberg, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2020

First Posted

June 2, 2020

Study Start

June 30, 2020

Primary Completion

October 25, 2021

Study Completion

October 25, 2021

Last Updated

January 11, 2022

Record last verified: 2022-01

Locations

US(1)