NCT04858620

A Study to Evaluate the Efficacy of Xlear vs. Placebo for Acute COVID-19 Infection

A Randomized Placebo Control Trial to Evaluate the Efficacy of Xlear vs. Placebo for Acute COVID-19 Infection

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Larkin Community Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	Xlear Nasal Spray	Xylitol plus Grapefruit Seed Extract (Xlear) nasal spray, 2 puffs per nostrils, every 6 hours
DRUG	Placebo	Saline nasal spray, 2 puffs per nostrils, every 6 hours

Timeline

• Start date: 2020-08-30
• Primary completion: 2021-08-30
• Completion: 2021-08-30
• First posted: 2021-04-26
• Last updated: 2023-10-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study