Status:
WITHDRAWN
A Study to Evaluate the Efficacy of Xlear vs. Placebo for Acute COVID-19 Infection
Lead Sponsor:
Larkin Community Hospital
Conditions:
Covid19
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
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 ...
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...
Eligibility Criteria
Inclusion
- Adults of ages 18 to 90 years of both sexes
- With positive SARS-CoV-2 carriage confirmed by nasopharyngeal PCR
- Signed informed consent
- Mild symptoms: Minimum respiratory symptoms or asymptomatic plus positive test
- Moderate symptoms: Respiratory symptoms such as cough, mild shortness of breath with mild oxygen desaturation(room air SpO2 \<92% and \>88% or \<88% corrected to \>92% with 2 liters of oxygen)
Exclusion
- Patient with very low viral load (threshold cycle \[Ct\] \> 25 per PCR).
- Known hypersensitivity to one of the constituents, particularly to xylitol or grapefruit seed extract (GSE)
- Under 18 years of age
- Women of childbearing age who are pregnant, breastfeeding mothers, and intend to become pregnant during the study period; unwilling/unable to take a pregnancy test.
- Unable to provide informed consent or decline to consent or unwillingness to adhere to the Standard of Care protocol.
- Patients with severe symptoms -Hypoxia (SpO2 \<88% not corrected by 2 liter non-concentrated oxygen) plus severe shortness of breath
- History of immunodeficiency or are currently receiving immunosuppressive therapy
- Have had a planned surgical procedure within the past 12 weeks.
- Already part of this trial, recruited at a different hospital.
- Patient unable to perform oro-nasopharyngeal decolonization
- Patients with acute exacerbation of severe comorbidities like heart disorders Chronic Obstructive Pulmonary Disease (COPD), Heart Failure New York Heart Association (NYHA) Class 3 and 4 and/or diseases with severe oxygenation problems
- Patients on Remdesivir and/or other clinical trials.
Key Trial Info
Start Date :
August 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04858620
Start Date
August 30 2020
End Date
August 30 2021
Last Update
October 16 2023
Active Locations (1)
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1
Larkin Community Hospital
Miami, Florida, United States, 33143