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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Recruitment Status : Withdrawn (No participants enrolled)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

Study Description
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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).

Condition or disease Intervention/treatment Phase
Coronavirus Disease (COVID-19) Drug: Fingolimod 0.5 mg Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Fingolimod in the Treatment of New Coronavirus Pneumonia (COVID-19)
Estimated Study Start Date : February 22, 2020
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment group 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
No Intervention: Control group


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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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): NCT04280588


Locations
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China
Wan-Jin Chen
Fuzhou, China
Sponsors and Collaborators
First Affiliated Hospital of Fujian Medical University
More Information
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Responsible Party: Ning Wang, MD., PhD., Doctor, First Affiliated Hospital of Fujian Medical University
ClinicalTrials.gov Identifier: NCT04280588    
Other Study ID Numbers: MRCTA, ECFAH of FMU [2020]027
First Posted: February 21, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Coronavirus Infections
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Fingolimod Hydrochloride
Sphingosine 1 Phosphate Receptor Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs