NCT05799521

A Nasal Treatment for COVID-19

A Novel Nasal Treatment for COVID-19

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• COVID-19
• Healthy

Interventions

Type	Name	Description
DRUG	Optate	Alkaline Buffer
DRUG	Placebo	Normal Saline

Timeline

• Start date: 2023-06-27
• Primary completion: 2026-03-30
• Completion: 2026-03-30
• First posted: 2023-04-05
• Last updated: 2025-12-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study