The goal of this study is to test an investigational new inhaled medication calledOptate.
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.
Drug: Optate
Alkaline Buffer
Other Name: Glycine
Drug: Placebo
Normal Saline
Other Name: Normal Saline
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
Riley Hospital for Children
Indianapolis, Indiana, United States
Investigator: Alyssa Laughlin
Contact: 317-274-3380
IUPulm@iupui.edu
Alyssa Laughlin
317-324-3380
IUpulm@iupui.edu
Kenzie Mahan
317-274-8899
krmahan@iu.edu
Not Provided