Trials / Unknown
UnknownNCT04661930
Fenofibrate for Patients With COVID-19 Requiring Hospitalization
A Study of a 10-days Fenofibrate Treatment, or Until Discharge From Hospital, Among COVID-19 Infected Patients Requiring Hospitalization
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 55 (estimated)
- Sponsor
- Yaakov Nahmias · Academic / Other
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label run-in followed by a randomized, double-blind drug treatment study of COVID-19 infected patients requiring inpatient hospital admission.
Detailed description
This is an open-label run-in followed by a randomized, double-blind drug treatment study of COVID-19 infected patients requiring inpatient hospital admission. Open-label patients will be matched at least 1:10 with observational retrospective Propensity score-matched (PSM) patients' medical files. The double-blinded step will be randomized 2:1 to daily Fenofibrate or placebo for 10 days or hospital discharge.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TriCor® 145mg tablets | Fenofibrate; 145 mg daily (1/day); oral administration; 10 days |
| OTHER | Placebo | Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration |
| OTHER | Usual care | All participants will otherwise receive usual medical care |
Timeline
- Start date
- 2021-01-01
- Primary completion
- 2022-05-01
- Completion
- 2022-07-01
- First posted
- 2020-12-10
- Last updated
- 2022-04-19
Locations
3 sites across 1 country: Israel
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04661930. Inclusion in this directory is not an endorsement.