Actively Recruiting
A Study of Apabetalone in Subjects With Long -COVID
Led by Resverlogix Corp · Updated on 2025-04-18
200
Participants Needed
3
Research Sites
49 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open label, multicentre, phase II clinical trial that aims to assess the efficacy and safety of oral Apabetalone with background dapagliflozin for up to 12 weeks in T2DM patients with a history of probable or confirmed SARS-CoV-2 infection, with symptoms within 3 months from the onset of COVID-19 that last for at least 2 months and cannot be explained by an alternative diagnosis.
CONDITIONS
Official Title
A Study of Apabetalone in Subjects With Long -COVID
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide written informed consent and comply with study procedures
- Male or female subjects aged 18 years or older at screening
- Documented diagnosis of type 2 diabetes mellitus by history, diabetes medication use, or HbA1c ≥6.5% at screening
- Taking dapagliflozin as part of diabetes treatment or willing to start sponsor-provided dapagliflozin 10 mg daily
- History of Long-COVID symptoms beginning within 3 months of COVID-19 onset lasting at least 2 months
- Long Covid Impact Tool score of 30 or higher at screening and Day 1 visit
- Negative SARS-CoV-2 test at screening and Day 1 visit
- Females of childbearing potential and nonsterile males with female partners of childbearing potential agree to use effective contraception or abstain during the study and 30 days after last dose
You will not qualify if you...
- Chronic kidney disease with estimated glomerular filtration rate (eGFR) less than 25 mL/min/1.73 m2
- New York Heart Association Class IV congestive heart failure
- Evidence of cirrhosis, hepatic encephalopathy, varices, active hepatitis, prior porta-caval shunt, or chronic liver diseases like primary biliary cholangitis or untreated hemochromatosis
- Elevated liver enzymes ALT or AST over 1.5 times the upper limit of normal or total bilirubin over 1.5 times the upper limit of normal
- Active hepatitis B or C virus infection
- History of positive HIV test
- Use of strong cytochrome P450 3A4 inducers or inhibitors or corticosteroids over 10 mg daily prednisone equivalent
- Received COVID-19 vaccine or booster within 30 days before screening
- Participation in clinical study with investigational medication within 30 days before screening
- Pregnant, planning pregnancy, breastfeeding, or positive pregnancy test at screening or enrollment
- Safety concerns or inability to comply with protocol as judged by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
The Speciality Hospital
Amman, Jordan
Not Yet Recruiting
2
MNGHA- King Abdulaziz Hospital
Al Mubarraz, Saudi Arabia
Not Yet Recruiting
3
Al Kuwait Hospital
Dubai, Dubai, United Arab Emirates
Actively Recruiting
Research Team
O
Omar Hamed
CONTACT
M
Moaz Rashad
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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