Status:
RECRUITING
A Study of Apabetalone in Subjects With Long -COVID
Lead Sponsor:
Resverlogix Corp
Conditions:
Post-Acute COVID-19 Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 his...
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 his...
Eligibility Criteria
Inclusion
- 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
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Exclusion
- 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.
Key Trial Info
Start Date :
April 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06590324
Start Date
April 15 2025
End Date
March 30 2026
Last Update
April 18 2025
Active Locations (3)
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1
The Speciality Hospital
Amman, Jordan
2
MNGHA- King Abdulaziz Hospital
Al Mubarraz, Saudi Arabia
3
Al Kuwait Hospital
Dubai, Dubai, United Arab Emirates