A Study of Apabetalone in Subjects With Long -COVID

NCT06590324 | Recruiting Phase 2 DMC

• 1 other identifier: RVX222-CS-025
• Study Type: interventional
• Target: 200
• Locations: 3 countries
• Sites: 3

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.

Conditions

Post-Acute COVID-19 Syndrome

Outcome Measures

Primary Outcomes (1)

• patient acceptable symptom state (PASS)

  The PASS assessment will consist of a single question phrased verbally by the delegated administrator as " Taking into account all your symptoms in daily life and your functional impairment, do you consider that your current state is satisfactory?". The response options are "Yes" or "No".

  90 days

Secondary Outcomes (5)

• Long COVID Symptom and Impact tools (LCST/LCIT)

  90 days

• Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue Short Form 7a (SF-7a)

  90 days

• Baseline Dyspnea Index (BDI) & Transition Dyspnea Index (TDI)

  90 days

• Post-COVID-19 Functional Status (PCFS) Scale

  90 days

• DePaul Symptom Questionnaire - Post-Exertional Malaise Short Form (DSQ-PEM)

  90 days

Other Outcomes (3)

• Biomarkers of inflammation

  Days 1,14,30,60,90

• biomarkers associated with Post-COVID-19 Condition and Chronic Fatigue Syndrome

  Days 1,14,30,60,90

• blood transcriptome and plasma proteome and metabolomics

  baseline in blood cell transcriptome at Day 1, Day 14 and change from baseline in plasma proteome at Days 1,14,30,60,90

Study Arms (1)

apabetalone

EXPERIMENTAL

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.

Drug: Apabetalone

Interventions

Apabetalone DRUG

100-mg capsule, twice daily oral administration with meals

Also known as: RVX000222

apabetalone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Male or female subjects who are ≥ 18 years of age at Screening.
• Documented diagnosis of T2DM (one or more of the following criteria must be met):
• Documented history of T2DM
• History of taking diabetes medication
• HbA1c ≥6.5% at Screening
• 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.
• 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).
• A Long Covid Impact Tool (LCIT) score of ≥ 30 at the Screening Visit and at Visit 2 (Day 1)
• A negative SARS-CoV-2 test at the Screening Visit and at Visit 2 (Day 1)
• 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

You may not qualify if:

• Subjects with chronic kidney disease (CKD) with an estimated glomerular filtration rate (eGFR) \<25 mL/min/1.73 m2
• New York Heart Association Class IV congestive heart failure
• 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
• 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)
• Subjects taking concomitant cytochrome P450 3A4 strong inducers and/or strong inhibitors, or corticosteroid use \>10 mg daily prednisone or equivalent.
• Subjects who have received a COVID-19 vaccine or booster in the last 30 days prior to screening (Visit 1).
• Subject who have participated in a clinical study and received any investigational medication within the last 30 days prior to screening (Visit 1).
• 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.
• 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.

Sponsors & Collaborators

• Resverlogix Corp: lead

Study Sites (3)

The Speciality Hospital

Amman, Jordan

NOT YET RECRUITING

MNGHA- King Abdulaziz Hospital

Al Mubarraz, Saudi Arabia

NOT YET RECRUITING

Al Kuwait Hospital

Dubai, Dubai, United Arab Emirates

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

apabetalone

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Sweeney, MD

  Resverlogix Corp

  STUDY DIRECTOR

Central Study Contacts

Omar Hamed

CONTACT

(+971)429704901; Omar.Hamed@pdc-cro.com

Moaz Rashad

CONTACT

(+971)581154600; moaz.rashad@pdc-cro.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open Label Study

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: September 19, 2024
• Study Start: April 15, 2025
• Primary Completion: December 30, 2025
• Study Completion: March 30, 2026
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1); SA (1); AE (1)