Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT04858620
Status:
WITHDRAWN
Last Update Posted:
2023-10-16
First Post:
2021-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy of Xlear vs. Placebo for Acute COVID-19 Infection
Sponsor:
Larkin Community Hospital
Organization:
Study Overview
Official Title:
A Randomized Placebo Control Trial to Evaluate the Efficacy of Xlear vs. Placebo for Acute COVID-19 Infection
Status:
WITHDRAWN
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study Period Ended / Not Completed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to find out the efficacy of Xlear nasal spray as an adjunct medication against COVID-19. This encompasses reduction in the number of days to negativization via nasal swab PCR from the average 14 days and early improvement of symptoms.
Detailed Description:
Patients will be informed about the study including potential risk and benefits. Once written informed consent are obtained, patients will undergo a brief screening period to determine eligibility for the study. Once eligibility is confirmed, eligible patients will be placed in a randomized placebo control manner. Patient will be assigned to Xlear (2 puffs per nostrils, every 3-4 hours a day) or placebo. Patient will be followed for 1 week. Inflammatory markers will be obtained on Day 4 and repeat COVID-19 Reverse Transcriptase PCR (RT PCR) on Day 7. Follow up will be done on Day 14 for all patients.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: