A Nasal Treatment for COVID-19

Phase 2RecruitingNCT05799521

Indiana University40 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

COVID-19 Healthy

Interventions

OptateDRUG

Alkaline Buffer

PlaceboDRUG

Normal Saline

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Riley Hospital for Children

Indianapolis, Indiana, United States

RECRUITING

Outcomes

Primary Outcomes

Change in SARS-CoV-2 Levels

SARS-CoV-2 levels will be measured in nasal wash before and one hour after Optate or placebo administration

Time frame: Immediately before and one-hour after treatment

Change in SNOT-22 score

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 one hour after administration.

Time frame: Immediately before and one-hour after treatment

Change in SNOT-22 score

Time frame: Immediately before and 24-hours after treatment