Last updated: October 12, 2023
Sponsor: Larkin Community Hospital
Overall Status: Trial Not Available
Phase
3
Condition
Covid-19
Treatment
Nasal Spray
Clinical Study ID
NCT04610801
LCH-3-082020
Ages 18-90 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Adults of ages 18 to 90 years of both sexes
- With positive SARS-CoV-2 carriage confirmed by nasopharyngeal PCR
- Signed informed consent
- 1- Mild symptoms: Minimum respiratory symptoms or asymptomatic plus positive test
- 2- Moderate symptoms: Respiratory symptoms such as cough, mild shortness of breathwith mild oxygen desaturation(room air SpO2 <92% and >88% or <88% corrected to >92%with 2lt of oxygen)
Exclusion
Exclusion Criteria:
- Patient with very low viral load (threshold cycle [Ct] > 25 per PCR).
- Known hypersensitivity to one of the constituents, particularly to xylitol or GSE
- Under 18 years of age
- Women of childbearing age who are pregnant, breastfeeding mothers, and intend tobecome 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 tothe Standard of Care protocol.
- Patients with severe symptoms -Hypoxia (SpO2 <88% not corrected by 2 liternon-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 ChronicObstructive 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.
Study Design
Treatment Group(s): 1
Primary Treatment: Nasal Spray
Phase: 3
Study Start date:
December 08, 2021
Estimated Completion Date:
August 08, 2022
Study Description
Connect with a study center
Larkin Community Hospital
Miami, Florida 33143
United StatesSite Not Available
Larkin Community Hospital Palm Springs Campus
Miami, Florida 33012
United StatesSite Not Available
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