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Fingolimod in COVID-19

F

Fujian Medical University (FJMU)

Status and phase

Withdrawn
Phase 2

Conditions

Coronavirus Disease (COVID-19)

Treatments

Drug: Fingolimod 0.5 mg

Study type

Interventional

Funder types

Other

Identifiers

NCT04280588
MRCTA, ECFAH of FMU [2020]027

Details and patient eligibility

About

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).

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Treatment group
Experimental group
Treatment:
Drug: Fingolimod 0.5 mg
Control group
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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