A Nasal Treatment for COVID-19

Purpose

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

Conditions

  • COVID-19
  • Healthy

Eligibility

Eligible Ages
Between 18 Years and 60 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
The study model arms will include participants with COVID-19 receiving treatment (experimental type), participants with COVID-19 receiving placebo (placebo comparator type), healthy controls receiving treatment (experimental type), and healthy controls receiving placebo.
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Providing pharmacy will randomize doses and provide blinded doses

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Participants with COVID-19:Treatment 		Participants with COVID-19:Treatment - subjects on this treatment arm will receive study drug
  • Drug: Optate
    Alkaline Buffer
    Other names:
    • Glycine
Placebo Comparator
Participants with COVID-19: Placebo 		Participants with COVID-19: Placebo - subjects on this arm will get placebo
  • Drug: Placebo
    Normal Saline
    Other names:
    • Normal Saline
Experimental
Healthy Controls: Treatment 		Healthy Controls: Treatment - subjects on this treatment arm will receive study drug
  • Drug: Optate
    Alkaline Buffer
    Other names:
    • Glycine
Placebo Comparator
Healthy Controls: Placebo 		Healthy Controls: Placebo - subjects on this arm will get placebo
  • Drug: Placebo
    Normal Saline
    Other names:
    • Normal Saline

Recruiting Locations

Riley Hospital for Children
Indianapolis 4259418, Indiana 4921868 46202
Contact:
Charles Clem
3172748899
IUPulm@iupui.edu

More Details

NCT ID
NCT05799521
Status
Recruiting
Sponsor
Indiana University

Study Contact

Charles Clem
317-274-8899
IUpulm@iupui.edu

Detailed Description

The goal of this study is to test an investigational new inhaled medication called Optate. Investigational means it has not been approved by the Food and Drug Administration (FDA) for this use. The investigators hypothesize that Optate will reduce the length of symptoms and disease severity in patients with COVID-19 (Coronavirus disease of 2019) through inhibition of SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) viral replication within the upper and lower airways. Testing this hypothesis is important because treatments for COVID-19 are needed alongside vaccines. COVID-19 begins in the nasal passages, so targeted therapies to the nasal passages at early stages of the disease may prevent severe disease from occurring.