Back to resultsFingolimod in COVID-19
Primary Purpose
Coronavirus Disease (COVID-19)
Status
Withdrawn
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Fingolimod 0.5 mg
Sponsored by
About this trial
This is an interventional treatment trial for Coronavirus Disease (COVID-19)
Eligibility Criteria
Inclusion Criteria:
- The patients who were diagnosed with the common type of NCP (including severe risk factors) and severe cases of new coronavirus pneumonia;
- Aged 18 to 85 years;
- Patients or authorized family members volunteered to participate in this study and signed informed consent.
Exclusion Criteria:
- Patients with any history of bradyarrhythmia or atrioventricular blocks
- Patients who are participating in other drug clinical trials;
- Pregnant or lactating women;
- ALT / AST> 5 ULN, neutrophils <0.5, platelets less than 50;
- Definite diagnosis of rheumatic immune-related diseases;
- Long-term oral anti-rejection or immunomodulatory drugs;
- Patients with active pulmonary tuberculosis, with definite bacterial and fungal infections.
Sites / Locations
- Wan-Jin Chen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment group
Control group
Arm Description
Outcomes
Primary Outcome Measures
The change of pneumonia severity on X-ray images
The lesion change on X-ray images from day 5 to baseline
Secondary Outcome Measures
Full Information
NCT ID
NCT04280588
First Posted
February 20, 2020
Last Updated
November 11, 2020
Sponsor
First Affiliated Hospital of Fujian Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04280588
Brief Title
Fingolimod in COVID-19
Official Title
Efficacy of Fingolimod in the Treatment of New Coronavirus Pneumonia (COVID-19)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Withdrawn
Why Stopped
No participants enrolled
Study Start Date
February 22, 2020 (Anticipated)
Primary Completion Date
July 1, 2020 (Anticipated)
Study Completion Date
July 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital of Fujian Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Although immune-inflammatory treatment is not routinely recommended to be used for SARS-CoV-2 pneumonia, according to the pathological findings of pulmonary oedema and hyaline membrane formation, timely and appropriate use of immune modulator together with ventilator support should be considered for the severe patients to prevent ARDS development. The sphingosine-1-phosphate receptor regulators Fingolimod (FTY720) is an effective immunology modulator which has been widely used in multiple sclerosis.The aim of this study was to determine whether the efficacy of fingolimod for a novel coronavirus disease (COVID-19).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Disease (COVID-19)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Fingolimod 0.5 mg
Intervention Description
Each patient in the fingolimod treatment group was given 0.5 mg of fingolimod orally once daily, for three consecutive days
Primary Outcome Measure Information:
Title
The change of pneumonia severity on X-ray images
Description
The lesion change on X-ray images from day 5 to baseline
Time Frame
5 day after fingolimod treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patients who were diagnosed with the common type of NCP (including severe risk factors) and severe cases of new coronavirus pneumonia;
Aged 18 to 85 years;
Patients or authorized family members volunteered to participate in this study and signed informed consent.
Exclusion Criteria:
Patients with any history of bradyarrhythmia or atrioventricular blocks
Patients who are participating in other drug clinical trials;
Pregnant or lactating women;
ALT / AST> 5 ULN, neutrophils <0.5, platelets less than 50;
Definite diagnosis of rheumatic immune-related diseases;
Long-term oral anti-rejection or immunomodulatory drugs;
Patients with active pulmonary tuberculosis, with definite bacterial and fungal infections.
Facility Information:
Facility Name
Wan-Jin Chen
City
Fuzhou
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
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Fingolimod in COVID-19
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