A Nasal Treatment for COVID-19

A Novel Nasal Treatment for COVID-19

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.

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