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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
100-mg capsule, twice daily oral administration with meals
The Speciality Hospital
Amman, Jordan
NOT_YET_RECRUITINGMNGHA- King Abdulaziz Hospital
Al Mubarraz, Saudi Arabia
NOT_YET_RECRUITINGAl Kuwait Hospital
Dubai, Dubai, United Arab Emirates
RECRUITINGpatient 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".
Time frame: 90 days
Long COVID Symptom and Impact tools (LCST/LCIT)
These questionnaires will be presented to the subjects in paper format as a patient-reported instrument. Subjects indicate with a check mark which of the 53 symptoms they have experienced in the last 30 days. Symptoms are scored as the number checked by the subject (0-53) The disease's impact on their lives over the past 30 days is scored from the responses to 6 questions. Subjects will answer using a numeric scale ranging from 0 (no impact) to 10 (maximal impact)
Time frame: 90 days
Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue Short Form 7a (SF-7a)
The PROMIS F-7a SF consists of seven items that measure both the experience of fatigue and the interference of fatigue on daily activities over the past week (NIH, 2007).
Time frame: 90 days
Baseline Dyspnea Index (BDI) & Transition Dyspnea Index (TDI)
The BDI and TDI are Interviewer-administered ratings of severity of dyspnea
Time frame: 90 days
Post-COVID-19 Functional Status (PCFS) Scale
The PCFS is an ordinal scale of 5 steps ranging from Grade 0 (No functional limitations) to Grade 4 (Severe functional limitations). This scale will be self-administered by the patient
Time frame: 90 days
DePaul Symptom Questionnaire - Post-Exertional Malaise Short Form (DSQ-PEM)
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Post-exertional malaise (PEM) is a key symptom of chronic fatigue syndrome (CFS). Currently, five PEM-items from the DePaul Symptom Questionnaire (DSQ) will be used in this study to measure this symptom for patients with Post Covid Condition
Time frame: 90 days