Fingolimod in COVID-19

November 11, 2020 updated by: Ning Wang, MD., PhD., First Affiliated Hospital of Fujian Medical University

Efficacy of Fingolimod in the Treatment of New Coronavirus Pneumonia (COVID-19)

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Fuzhou, China
        • Wan-Jin Chen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control group
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 day after fingolimod treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Fujian Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

February 22, 2020

Primary Completion (ANTICIPATED)

July 1, 2020

Study Completion (ANTICIPATED)

July 1, 2020

Study Registration Dates

First Submitted

February 20, 2020

First Submitted That Met QC Criteria

February 20, 2020

First Posted (ACTUAL)

February 21, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 13, 2020

Last Update Submitted That Met QC Criteria

November 11, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRCTA, ECFAH of FMU [2020]027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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