NCT06590324 A Study of Apabetalone in Subjects With Long -COVID
| NCT ID | NCT06590324 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Resverlogix Corp |
| Condition | Post-Acute COVID-19 Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-04-15 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 200 participants in total. It began in 2025-04-15 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Able and willing to provide written (signed and dated) informed consent before participation in the study, and to comply with scheduled visits, treatment plan, and other study-related procedures to complete the study. 2. Male or female subjects who are ≥ 18 years of age at Screening. 3. Documented diagnosis of T2DM (one or more of the following criteria must be met): 1. Documented history of T2DM 2. History of taking diabetes medication 3. HbA1c ≥6.5% at Screening 4. Must be taking dapagliflozin as part of their diabetes medication, or, based on the Principal Investigator's judgment and indication, be willing to commence sponsor-provided dapagliflozin 10 mg daily for the duration of the study. 5. History of Long-COVID symptoms within 3 months from the onset of COVID-19 that have lasted for at least 2 months. Symptoms are listed in Long Covid Symptom Tool (LCST). 6. A Long Covid Impact Tool (LCIT) score of ≥ 30 at the Screening Visit and at Visit 2 (Day 1) 7. A negative SARS-CoV-2 test at the Screening Visit and at Visit 2 (Day 1) 8. Female subjects of childbearing potential and nonsterile male subjects with female partners of childbearing potential must agree to either remain abstinent or use highly effective non-hormonal methods of contraception throughout the study and at least 30 days after the last dose of study drug has been taken. Subjects must adhere to contraceptive use consistent with local regulations regarding the methods of contraception for those participating in clinical studies \- Exclusion Criteria: 9. Subjects with chronic kidney disease (CKD) with an estimated glomerular filtration rate (eGFR) \<25 mL/min/1.73 m2 10. New York Heart Association Class IV congestive heart failure 11. Evidence of cirrhosis from liver imaging or biopsy, a history of hepatic encephalopathy, esophageal or gastric varices, active hepatitis, or prior porta-caval shunt procedure; chronic liver diseases such as primary biliary cholangitis, untreated hemochromatosis, and primary sclerosing cholangitis 12. Subject meets any of the following laboratory criteria at Screening: * Alanine transaminase (ALT) or aspartate transaminase (AST) values \> 1.5x the upper limit of normal (ULN) * Total bilirubin \>1.5 × ULN. * Evidence of an active hepatitis B virus or hepatitis C virus infection * History of a positive test for human immunodeficiency virus (HIV) 13. Subjects taking concomitant cytochrome P450 3A4 strong inducers and/or strong inhibitors, or corticosteroid use \>10 mg daily prednisone or equivalent. 14. Subjects who have received a COVID-19 vaccine or booster in the last 30 days prior to screening (Visit 1). 15. Subject who have participated in a clinical study and received any investigational medication within the last 30 days prior to screening (Visit 1). 16. Female subjects who are pregnant, planning to get pregnant, lactating/breastfeeding, or has a positive urine pregnancy test at the Screening Visit or prior to enrollment at the Day 1 visit. 17. Subjects whose safety may be compromised by study participation or are not, in the opinion of the investigator, able or willing to comply with the protocol.
Contact & Investigator
Michael Sweeney, MD
STUDY DIRECTOR
Resverlogix Corp
Frequently Asked Questions
Who can join the NCT06590324 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Post-Acute COVID-19 Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06590324 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06590324 currently recruiting?
Yes, NCT06590324 is actively recruiting participants. Contact the research team at Omar.Hamed@pdc-cro.com for enrollment information.
Where is the NCT06590324 trial being conducted?
This trial is being conducted at Amman, Jordan, Al Mubarraz, Saudi Arabia, Dubai, United Arab Emirates.
Who is sponsoring the NCT06590324 clinical trial?
NCT06590324 is sponsored by Resverlogix Corp. The principal investigator is Michael Sweeney, MD at Resverlogix Corp. The trial plans to enroll 200 participants.
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