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Fingolimod in COVID-19

NCT ID: NCT04280588

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-22

Study Completion Date

2020-07-01

Brief Summary

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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

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Conditions

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Coronavirus Disease (COVID-19)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment group

Group Type EXPERIMENTAL

Fingolimod 0.5 mg

Intervention Type DRUG

Each patient in the fingolimod treatment group was given 0.5 mg of fingolimod orally once daily, for three consecutive days

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Ning Wang, MD., PhD.

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Wan-Jin Chen

Fuzhou, , China

Site Status

Countries

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China

Other Identifiers

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MRCTA, ECFAH of FMU [2020]027

Identifier Type: -

Identifier Source: org_study_id