A Nasal Treatment for COVID-19

Study Overview
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Brief Summary
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The goal of this study is to test an investigational new inhaled medication called Optate.

Detailed Description
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The goal of this study is to test an investigational new inhaled medication called Optate. Investigational means it has not been approved by the Food and Drug Administration (FDA) for this use. The investigators hypothesize that Optate will reduce the length of symptoms and disease severity in patients with COVID-19 (Coronavirus disease of 2019) through inhibition of SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) viral replication within the upper and lower airways. Testing this hypothesis is important because treatments for COVID-19 are needed alongside vaccines. COVID-19 begins in the nasal passages, so targeted therapies to the nasal passages at early stages of the disease may prevent severe disease from occurring.

Official Title
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A Novel Nasal Treatment for COVID-19

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Optate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects, 18 and above, with mild COVID-19 upper respiratory tract infection symptoms positive rapid COVID-19 test Ordinal Scale for Clinical Improvement < 3 (OSCI, Appendix 2) and/or Fever > 100 degree F and/or Nasal congestion Exclusion Criteria: FEV1 (Forced Exhaled Volume) < 55% predicted on the day of study procedures OSCI ≥ 3 (Objective Structured Clinical Exam) Inability to follow commands or perform study procedures including spirometry, coordinated inhalation of study medication

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: People who test positive for COVID-19
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>subjects on Treatment arm will get study drug | Drug: Optate<br>* Alkaline Buffer<br>* Other names: Glycine;|
| Placebo Comparator: Placebo<br>subjects on Treatment arm will get placebo | Drug: Placebo<br>* Normal Saline<br>* Other names: Normal Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of Clinical Respiratory Viral panels and SARS-CoV-2 Levels | Clinical respiratory viral panels and SARS-CoV-2 levels will be measured in nasal wash before and one hour after Optate or placebo administration | 6 months after enrollment opens | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survey assessment | 3.1.2 SNOT-22 scores (a validated, 22-item quality of life instrument survey) will be assessed immediately prior to Optate or placebo administration. Scores will be reassessed one hour after administration and 24 hours after administration. | 6 months after enrollment closes |