A Novel Nasal Treatment for COVID-19
Indiana University
Summary
The goal of this study is to test an investigational new inhaled medication called Optate.
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…
Eligibility
- Age range
- 18–60 years
- Sex
- All
- Healthy volunteers
- Yes
COVID-19 PARTICIPANTS 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 HEALTHY CONTROLS Inclusion Crite…
Interventions
- DrugOptate
Alkaline Buffer
- DrugPlacebo
Normal Saline
Location
- Riley Hospital for ChildrenIndianapolis, Indiana