RecruitingPhase 2NCT05799521

A Nasal Treatment for COVID-19

A Novel Nasal Treatment for COVID-19


Sponsor

Indiana University

Enrollment

40 participants

Start Date

Jun 27, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria6

  • positive rapid COVID-19 test
  • Ordinal Scale for Clinical Improvement < 3 (OSCI, Appendix 2) and/or
  • Fever > 100 degree F and/or
  • Nasal congestion
  • 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 Criteria6

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

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Interventions

DRUGOptate

Alkaline Buffer

DRUGPlacebo

Normal Saline


Locations(1)

Riley Hospital for Children

Indianapolis, Indiana, United States

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NCT05799521


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