Fingolimod in COVID-19

Coronavirus Disease (COVID-19) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04280588
• Other study ID #: MRCTA, ECFAH of FMU [2020]027
• Status: Withdrawn
• Phase: Phase 2
• Start date: February 22, 2020
• Est. completion date: July 1, 2020

Study information

• Verified date: November 2020
• Source: First Affiliated Hospital of Fujian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Disease (COVID-19)
• Coronavirus Infections

Intervention

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

Locations

Country	Name	City	State
China	Wan-Jin Chen	Fuzhou

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of pneumonia severity on X-ray images	The lesion change on X-ray images from day 5 to baseline	5 day after fingolimod treatment