RECRUITINGPhase 2INTERVENTIONAL
A Nasal Treatment for COVID-19
A Novel Nasal Treatment for COVID-19
About This Trial
The goal of this study is to test an investigational new inhaled medication called Optate.
Who May Be Eligible (Plain English)
COVID-19 PARTICIPANTS Who May Qualify: 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
Who Should NOT Join This Trial:
- 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 Who May Qualify: 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.
Who Should NOT Join This Trial:
- Pregnancy
- Inability to follow commands or perform study procedures including spirometry, coordinated inhalation of study medication
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Exclusion Criteria:
* Pregnancy
* Inability to follow commands or perform study procedures including spirometry, coordinated inhalation of study medication
Treatments Being Tested
DRUG
Optate
Alkaline Buffer
DRUG
Placebo
Normal Saline
Locations (1)
Riley Hospital for Children
Indianapolis, Indiana, United States