A Study of Apabetalone in Subjects With Long -COVID

Resverlogix

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Post-Acute COVID-19 Syndrome

Treatments: Drug: Apabetalone

Study type: Interventional

Funder types: Industry

Identifiers

NCT06590324

RVX222-CS-025

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

apabetalone

Experimental group

Description:

apabetalone selectively binds to the second bromodomain \[BD2\] of bromodomain extra terminal (BET) proteins, curbing the transcription of multiple disease associated genes that promote vascular inflammation, complement, acute phase response (APR), fibrosis, dyslipidemia, and vascular calcification.

Treatment:

Drug: Apabetalone