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Fingolimod in 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04280588
Recruitment Status : Withdrawn (No participants enrolled)
First Posted : February 21, 2020
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
Ning Wang, MD., PhD., First Affiliated Hospital of Fujian Medical University

Tracking Information
First Submitted Date  ICMJE February 20, 2020
First Posted Date  ICMJE February 21, 2020
Last Update Posted Date November 13, 2020
Estimated Study Start Date  ICMJE February 22, 2020
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2020)
The change of pneumonia severity on X-ray images [ Time Frame: 5 day after fingolimod treatment ]
The lesion change on X-ray images from day 5 to baseline
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fingolimod in COVID-19
Official Title  ICMJE Efficacy of Fingolimod in the Treatment of New Coronavirus Pneumonia (COVID-19)
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coronavirus Disease (COVID-19)
Intervention  ICMJE Drug: Fingolimod 0.5 mg
Each patient in the fingolimod treatment group was given 0.5 mg of fingolimod orally once daily, for three consecutive days
Study Arms  ICMJE
  • Experimental: Treatment group
    Intervention: Drug: Fingolimod 0.5 mg
  • No Intervention: Control group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 11, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: February 20, 2020)
30
Estimated Study Completion Date  ICMJE July 1, 2020
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04280588
Other Study ID Numbers  ICMJE MRCTA, ECFAH of FMU [2020]027
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Responsible Party Ning Wang, MD., PhD., First Affiliated Hospital of Fujian Medical University
Study Sponsor  ICMJE First Affiliated Hospital of Fujian Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account First Affiliated Hospital of Fujian Medical University
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP