Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06437223
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-16
Brief Title:
Study of Xiflam Treatment in Patients Post COVID-19 Infection Suffering From What is Known as Long COVID LC
Sponsor:
Inflammx Therapeutics Inc
Organization:
Inflammx Therapeutics Inc
Study Overview
Official Title:
A Phase 2 Study to Compare the Efficacy and Safety of Orally Administered Xiflam Therapy With Orally Administered Placebo in Patients With Ocular and Systemic Manifestations of Post COVID Sequelae Known as Long COVID
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to evaluate the safety and efficacy of Xiflam versus Placebo in patients who present with signs and symptoms of Long COVID
Xiflam n10 or placebo n5 will be administered orally once a day QD for 12 weeks
Xiflam n10 or placebo n5 will be administered orally once a day QD for 12 weeks
Detailed Description:
This is a Phase 2a randomized masked placebo-controlled clinical trial to evaluate the safety and efficacy of Xiflam for use in patients with signssymptoms of Long COVID Patients will be randomized to Xiflam the study drug n10 or Placebo n5 Both Xiflam and Placebo will be taken once daily by mouth for 12 weeks
I Baseline Screening Visit After obtaining informed consent and before treatment is initiated an initial study visit will be conducted in person to confirm subject eligibility Subjects will be asked complete a baseline questionnaire to assess signs and symptom severity During this screening visit a baseline blood sample will be obtained to determine any changes over time in any of the measured parameters These include biomarkers of inflammation Additional study procedures occurring during the baselinescreening phase of this study are outlined in the protocol Patients who are found not to meet inclusion criteria will not be entered into the treatment Phase of the study
I Baseline Screening Visit After obtaining informed consent and before treatment is initiated an initial study visit will be conducted in person to confirm subject eligibility Subjects will be asked complete a baseline questionnaire to assess signs and symptom severity During this screening visit a baseline blood sample will be obtained to determine any changes over time in any of the measured parameters These include biomarkers of inflammation Additional study procedures occurring during the baselinescreening phase of this study are outlined in the protocol Patients who are found not to meet inclusion criteria will not be entered into the treatment Phase of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None