Evaluating Apabetalone for Long-COVID in Diabetes Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, multicenter clinical trial aims to evaluate the efficacy and safety of oral Apabetalone in combination with dapagliflozin for up to 12 weeks in patients with Type 2 Diabetes Mellitus (T2DM) who have experienced Long-COVID symptoms. Participants will receive Apabetalone alongside their existing dapagliflozin treatment, with a total of seven in-person clinic visits to monitor their progress. The study will assess various primary, secondary, and exploratory endpoints to determine the impact of the treatment on Long-COVID symptoms.

Why it matters

Who can join: the full rules

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

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   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.

Where it's running

• Al Kuwait Hospital
  Dubai, Dubai, United Arab Emirates Recruiting
• The Speciality Hospital
  Amman, Jordan Not yet recruiting
• MNGHA- King Abdulaziz Hospital
  Al Mubarraz, Saudi Arabia Not yet recruiting

Study contacts

• Study coordinator: Omar Hamed
• Email: Omar.Hamed@pdc-cro.com
• Phone: (+971)429704901

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.