Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06590324
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
A Study of Apabetalone in Subjects with Long -COVID
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase II Multi-centre Open Label Study to Assess the Efficacy and Safety of Oral Apabetalone with Background Dapagliflozin in Subjects with Long -COVID-19 Post-COVID-19 Conditions and Type 2 Diabetes Mellitus T2DM
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None