A Nasal Treatment for COVID-19

Phase 2

Recruiting

• Conditions: COVID-19
• Interventions: Drug: Optate; Drug: Placebo

• Registration Number: NCT05799521
• Lead Sponsor: Indiana University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-03-24
• Study First Submitted QC: 2023-04-04
• Study First Posted: 2023-04-05
• Study Start: 2023-06-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-04
• Primary Completion: 2026-03-30
• Study Completion: 2026-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Optate	subjects on Treatment arm will get study drug
Placebo	Placebo	subjects on Treatment arm will get placebo

Primary Outcome Measures

Name	Time	Method
Change in SARS-CoV-2 Levels	Immediately before and one-hour after treatment	SARS-CoV-2 levels will be measured in nasal wash before and one hour after Optate or placebo administration
Change in SNOT-22 score	Immediately before and 24-hours after treatment	SNOT-22 scores (a validated, 22-item quality of life instrument survey) will be assessed immediately prior to Optate or placebo administration. The SNOT-22 assesses five domains (nasal, ear/facial, sleep, function and emotion) on a Likert scale from 0-5, where 0 means no problems and 5 means the worst possible problems. The total score ranges from 0-110, with higher scores indicating more severe symptoms. Scores will be reassessed 24 hours after administration.

Secondary Outcome Measures

Name	Time	Method
Change in SARS-CoV-2 Levels	Immediately before and one-hour after treatment	SARS-CoV-2 levels will be measured in exhaled breath condensate before and one hour after Optate or placebo administration
Change in nasal pH	Immediately before and one-hour after treatment	Nasal pH will be measured by a nasal pH meter before and one hour after Optate or placebo administration

Trial Locations

Locations (1)

Riley Hospital for Children; 🇺🇸 Indianapolis, Indiana, United States