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RECRUITINGPhase 2INTERVENTIONAL

A Nasal Treatment for COVID-19

A Novel Nasal Treatment for COVID-19

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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