Fingolimod in COVID-19

NCT04280588 | Withdrawn Phase 2

• 1 other identifier: MRCTA, ECFAH of FMU [2020]027
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Coronavirus Disease (COVID-19)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Treatment group

EXPERIMENTAL

Drug: Fingolimod 0.5 mg

Control group

NO INTERVENTION

Interventions

Fingolimod 0.5 mg DRUG

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

Treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University: lead

Study Sites (1)

Wan-Jin Chen

Fuzhou, China

Location

MeSH Terms

Conditions

COVID-19

Interventions

Fingolimod Hydrochloride

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Sphingosine; Amino Alcohols; Alcohols; Organic Chemicals; Propylene Glycols; Glycols; Amines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: February 21, 2020
• Study Start: February 22, 2020
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CN (1)