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RecruitingPhase 2NCT05799521

A Nasal Treatment for COVID-19

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Plain-language summary for patients

Trial Parameters

ConditionCOVID-19
SponsorIndiana University
Study TypeINTERVENTIONAL
PhasePhase 2
Enrollment40
SexALL
Min Age18 Years
Max Age60 Years
Start Date2023-06-27
Completion2026-03-30
All Conditions
Interventions
OptatePlacebo

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Brief Summary

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

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 stud

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