A Study of Apabetalone in Subjects With Long -COVID
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 f
| Condition(s) | Post-Acute COVID-19 Syndrome |
|---|---|
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Study type | Interventional |
| 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. |
| Who can participate | 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- |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Resverlogix Corp |
| Locations | Amman, Jordan; Al Mubarraz, Saudi Arabia; Dubai, Dubai, United Arab Emirates |
| Start date | 2025-04-15 |
| NCT ID | NCT06590324 |
| Official listing | https://clinicaltrials.gov/study/NCT06590324 |