Official Title
A Novel Nasal Treatment for COVID-19
Brief Summary

The goal of this study is to test an investigational new inhaled medication calledOptate.

Detailed Description

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.

Recruiting
COVID-19

Drug: Optate

Alkaline Buffer
Other Name: Glycine

Drug: Placebo

Normal Saline
Other Name: Normal Saline

Eligibility Criteria

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)

- Pregnancy

- Inability to follow commands or perform study procedures including spirometry,
coordinated inhalation of study medication

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 60 Years
Countries
United States
Locations

Riley Hospital for Children
Indianapolis, Indiana, United States

Investigator: Alyssa Laughlin
Contact: 317-274-3380
IUPulm@iupui.edu

Contacts

Alyssa Laughlin
317-324-3380
IUpulm@iupui.edu

Kenzie Mahan
317-274-8899
krmahan@iu.edu

Not Provided

Indiana University
NCT Number
MeSH Terms
COVID-19
Glycine