A Study of Apabetalone in Subjects With Long -COVID

NCT ID: NCT06590324

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-15
• Study Completion Date: 2026-03-30

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.

Detailed 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.

Conditions

Post-Acute COVID-19 Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

apabetalone

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.

Group Type: EXPERIMENTAL

Apabetalone

Intervention Type: DRUG

100-mg capsule, twice daily oral administration with meals

Interventions

Apabetalone

100-mg capsule, twice daily oral administration with meals

Intervention Type: DRUG

Other Intervention Names

RVX000222

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

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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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Resverlogix Corp

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Sweeney, MD

Role: STUDY_DIRECTOR

Resverlogix Corp

Locations

The Speciality Hospital

Amman, , Jordan

Site Status: NOT_YET_RECRUITING

MNGHA- King Abdulaziz Hospital

Al Mubarraz, , Saudi Arabia

Site Status: NOT_YET_RECRUITING

Al Kuwait Hospital

Dubai, Dubai, United Arab Emirates

Site Status: RECRUITING

Countries

Jordan; Saudi Arabia; United Arab Emirates

Central Contacts

Omar Hamed

Role: CONTACT

Omar.Hamed@pdc-cro.com

(+971)429704901

Moaz Rashad

Role: CONTACT

moaz.rashad@pdc-cro.com

(+971)581154600

Facility Contacts

Mohammed Hasan Jafar, MD

Role: primary

r.elayyan70@gmail.com

(+962)795112543

Maram Al Subaiee, MD

Role: primary

CTS_feasibility@MNGHA.MED.SA

(+966)-542725431

Suad Hannawi, MD

Role: primary

suadhannawi@gmail.com

+971 50 551 6624

Other Identifiers

RVX222-CS-025

Identifier Type: -

Identifier Source: org_study_id