A Nasal Treatment for COVID-19
Purpose
The goal of this study is to test an investigational new inhaled medication called Optate.
Condition
- COVID-19
Eligibility
- Eligible Ages
- Between 18 Years and 60 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- People who test positive for COVID-19
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
- Masking Description
- Providing pharmacy will randomize doses and provide blinded doses
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Treatment |
subjects on Treatment arm will get study drug |
|
|
Placebo Comparator Placebo |
subjects on Treatment arm will get placebo |
|
Recruiting Locations
Indianapolis, Indiana 46202
More Details
- NCT ID
- NCT05799521
- Status
- Recruiting
- Sponsor
- Indiana University
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.