Nasal treatment for COVID-19 symptoms
A Novel Nasal Treatment for COVID-19
This study is testing a new inhaled treatment called Optate to see if it can help adults with mild COVID-19 symptoms feel better and recover faster.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT05799521 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate an investigational inhaled medication called Optate for treating COVID-19. The medication is designed to inhibit the replication of the SARS-CoV-2 virus in the upper and lower airways, potentially reducing the severity and duration of symptoms. Participants will be adults aged 18 and older who exhibit mild COVID-19 symptoms and have tested positive for the virus. The study will compare the effects of Optate against a placebo to determine its efficacy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with mild COVID-19 symptoms and a positive rapid test.
Not a fit: Patients with severe respiratory issues or those who are pregnant may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could provide a targeted approach to alleviate COVID-19 symptoms and prevent the progression to severe disease.
How similar studies have performed: While there have been various approaches to treating COVID-19, the specific use of a nasal treatment like Optate is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Indianapolis, Indiana
- Riley Hospital for Children — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Study coordinator: Charles Clem
- Email: IUpulm@iupui.edu
- Phone: 317-274-8899
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.