Actively Recruiting
Open Label Phase II Study of Oral Apabetalone with Dapagliflozin in Adults with Type 2 Diabetes and Long COVID Symptoms
Led by Resverlogix Corp · Updated on 2025-04-18
200
Participants Needed
3
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of oral Apabetalone combined with background dapagliflozin treatment for up to 12 weeks in adults with type 2 diabetes mellitus T2DM who have experienced probable or confirmed COVID-19 infection. Participants must have symptoms of Long COVID lasting at least 2 months within 3 months from the start of COVID-19, which cannot be explained by other diagnoses. This phase II, open-label multicentre trial aims to better understand treatment options for this group of patients. Participants will take oral Apabetalone 100 mg capsules twice daily with meals while continuing their daily dapagliflozin 10 mg therapy for diabetes. The study involves seven in-person clinic visits where data will be collected to assess the treatments effects. After screening and consent, eligible participants begin Apabetalone treatment on Day 1 and continue it at home under study supervision. During the trial, participants will undergo various assessments including symptom evaluations and functional status tools related to Long COVID. The primary outcome is the patient acceptable symptom state at 90 days. Secondary measures include fatigue, dyspnea, and post-exertional malaise assessments. Safety and adherence will be monitored throughout, with the total study duration covering treatment and follow-up visits over approximately 12 weeks.
CONDITIONS
Brief 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, medication use, or HbA1c ≥6.5% at screening
- Taking dapagliflozin as part of diabetes treatment or willing to start dapagliflozin 10 mg daily during the study
- History of Long COVID symptoms within 3 months from onset of COVID-19 lasting at least 2 months
- Long COVID Impact Tool (LCIT) score of 30 or higher at screening and Day 1
- Negative SARS-CoV-2 test at screening and Day 1
- Female subjects of childbearing potential and nonsterile males with partners of childbearing potential agree to use effective contraception during and 30 days after the study
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 or history of severe liver disease including cirrhosis, hepatic encephalopathy, varices, active hepatitis, or prior porta-caval shunt
- Liver enzyme levels (ALT or AST) greater than 1.5 times upper limit of normal
- Total bilirubin greater than 1.5 times upper limit of normal
- Active hepatitis B or C infection
- History of positive HIV test
- Use of strong cytochrome P450 3A4 inducers or inhibitors, or corticosteroids exceeding 10 mg prednisone daily
- Received COVID-19 vaccine or booster within 30 days prior to screening
- Received investigational medication within 30 days prior to screening
- Pregnant, planning pregnancy, breastfeeding, or positive pregnancy test at screening or enrollment
- Any condition that may compromise safety or compliance as judged by the investigator
Research Team
O
Omar Hamed
M
Moaz Rashad
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