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A Nasal Treatment for COVID-19

NCT05799521

Active Not RecruitingPhase 2

Sponsor: Indiana University

Conditions: COVID-19, Healthy

Interventions: Optate, Placebo

Countries: United States

The goal of this study is to test an investigational new inhaled medication called Optate.

Eligibility overview

Sex: ALL

Age: 18 Years to 60 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility 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.

Exclusion Criteria:

* Pregnancy
* Inability to follow commands or perform study procedures including spirometry, coordinated inhalation of study medication

Locations (1)

Indianapolis, Indiana, United States