Fingolimod in COVID-19

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT04280588
• Date of registration: 20/02/2020
• Prospective Registration: Yes
• Primary sponsor: First Affiliated Hospital of Fujian Medical University
• Public title: Fingolimod in COVID-19
• Scientific title: Efficacy of Fingolimod in the Treatment of New Coronavirus Pneumonia (COVID-19)
• Date of first enrolment: February 22, 2020
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT04280588
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

China

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Coronavirus Disease (COVID-19)

Intervention(s)

Drug: Fingolimod 0.5 mg

Primary Outcome(s)

The change of pneumonia severity on X-ray images [Time Frame: 5 day after fingolimod treatment]

Secondary ID(s)

MRCTA, ECFAH of FMU [2020]027

Source(s) of Monetary Support

Please refer to primary and secondary sponsors