This is an open label, multicentre, phase II clinical trial that aims to assess theefficacy and safety of oral Apabetalone with background dapagliflozin for up to 12 weeksin T2DM patients with a history of probable or confirmed SARS-CoV-2 infection, withsymptoms within 3 months from the onset of COVID-19 that last for at least 2 months andcannot be explained by an alternative diagnosis.
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. Subjects will be receiving background
therapy with dapagliflozin 10 mg daily.
In-person clinic visits will be used to collect data to assess the primary and secondary
and exploratory endpoints. There will be 7 in-person visits.
After signing the informed consent form (ICF), and after all screening procedures have
been performed, subject data will be reviewed by the Principal Investigator to determine
subject eligibility. Eligible subjects will return for Visit 2 (Day 1) and assessments
will be performed per the Schedule of Events. Subjects will be enrolled and treatment
with Oral Apabetalone 100mg will be initiated. Subjects will be dispensed study drug to
be administered at home with meals, twice daily.
Drug: Apabetalone
100-mg capsule, twice daily oral administration with meals
Other Name: RVX000222
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.
The Speciality Hospital
Amman, Jordan
MNGHA- King Abdulaziz Hospital
Al Mubarraz, Saudi Arabia
Al Kuwait Hospital
Dubai, United Arab Emirates
Omar Hamed
(+971)429704901
Omar.Hamed@pdc-cro.com
Moaz Rashad
(+971)581154600
moaz.rashad@pdc-cro.com
Michael Sweeney, MD, Study Director
Resverlogix Corp