COVID-19, Healthy
Conditions
Brief summary
The goal of this study is to test an investigational new inhaled medication called Optate.
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.
Interventions
DRUGOptate
Alkaline Buffer
DRUGPlacebo
Normal Saline
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Providing pharmacy will randomize doses and provide blinded doses
Intervention model description
The study model arms will include participants with COVID-19 receiving treatment (experimental type), participants with COVID-19 receiving placebo (placebo comparator type), healthy controls receiving treatment (experimental type), and healthy controls receiving placebo.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
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 Criteria: Subjects, 18 and above, without mild COVID-19 upper respiratory tract infection symptoms * negative rapid COVID-19 test * No known medical problems or taking any medication that, in the investigator's opinion, would make them unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in SARS-CoV-2 Levels | Immediately before and one-hour after treatment | SARS-CoV-2 levels will be measured in nasal wash before and one hour after Optate or placebo administration |
| Change in SNOT-22 score | Immediately before and one-hour after treatment | SNOT-22 scores (a validated, 22-item quality of life instrument survey) will be assessed immediately prior to Optate or placebo administration. The SNOT-22 assesses five domains (nasal, ear/facial, sleep, function and emotion) on a Likert scale from 0-5, where 0 means no problems and 5 means the worst possible problems. The total score ranges from 0-110, with higher scores indicating more severe symptoms. Scores will be reassessed one hour after administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in SARS-CoV-2 Levels | Immediately before and one-hour after treatment | SARS-CoV-2 levels will be measured in exhaled breath condensate before and one hour after Optate or placebo administration |
| Change in nasal pH | Immediately before, immediately after and one-hour after treatment | Nasal pH will be measured by a nasal pH meter before, immediately after and one hour after Optate or placebo administration |
Countries
United States
Outcome results
None listed