A Nasal Treatment for COVID-19

NCT05799521 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 15989
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COVID-19; Healthy

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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 24 hours after administration.

  Immediately before and 24-hours after treatment

Secondary Outcomes (2)

• Change in SARS-CoV-2 Levels

  Immediately before and one-hour after treatment

• Change in nasal pH

  Immediately before, immediately after and one-hour after treatment

Study Arms (4)

Participants with COVID-19:Treatment

EXPERIMENTAL

Participants with COVID-19:Treatment - subjects on this treatment arm will receive study drug

Drug: Optate

Participants with COVID-19: Placebo

PLACEBO COMPARATOR

Participants with COVID-19: Placebo - subjects on this arm will get placebo

Drug: Placebo

Healthy Controls: Treatment

EXPERIMENTAL

Healthy Controls: Treatment - subjects on this treatment arm will receive study drug

Drug: Optate

Healthy Controls: Placebo

PLACEBO COMPARATOR

Healthy Controls: Placebo - subjects on this arm will get placebo

Drug: Placebo

Interventions

Optate DRUG

Alkaline Buffer

Also known as: Glycine

Healthy Controls: Treatment; Participants with COVID-19:Treatment

Placebo DRUG

Normal Saline

Also known as: Normal Saline

Healthy Controls: Placebo; Participants with COVID-19: Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• positive rapid COVID-19 test
• Ordinal Scale for Clinical Improvement \< 3 (OSCI, Appendix 2) and/or
• Fever \> 100 degree F and/or
• Nasal congestion

You may not qualify if:

• 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
• 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.
• Pregnancy
• Inability to follow commands or perform study procedures including spirometry, coordinated inhalation of study medication

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

RECRUITING

Related Publications (9)

• Davis MD, Donn SM, Ward RM. Administration of Inhaled Pulmonary Vasodilators to the Mechanically Ventilated Neonatal Patient. Paediatr Drugs. 2017 Jun;19(3):183-192. doi: 10.1007/s40272-017-0221-9.

  PMID: 28374138 BACKGROUND

• Davis MD, Hunt J. Exhaled breath condensate pH assays. Immunol Allergy Clin North Am. 2012 Aug;32(3):377-86. doi: 10.1016/j.iac.2012.06.003. Epub 2012 Jul 10.

  PMID: 22877616 BACKGROUND

• Davis MD, Walsh BK, Dwyer ST, Combs C, Vehse N, Paget-Brown A, Pajewski T, Hunt JF. Safety of an alkalinizing buffer designed for inhaled medications in humans. Respir Care. 2013 Jul;58(7):1226-32. doi: 10.4187/respcare.01753. Epub 2012 Dec 18.

  PMID: 23258576 BACKGROUND

• Hunt JF, Fang K, Malik R, Snyder A, Malhotra N, Platts-Mills TA, Gaston B. Endogenous airway acidification. Implications for asthma pathophysiology. Am J Respir Crit Care Med. 2000 Mar;161(3 Pt 1):694-9. doi: 10.1164/ajrccm.161.3.9911005.

  PMID: 10712309 BACKGROUND

• Ngamtrakulpanit L, Yu Y, Adjei A, Amoah G, Gaston B, Hunt J. Identification of Intrinsic Airway Acidification in Pulmonary Tuberculosis. Glob J Health Sci. 2010 Apr;2(1):106-110. doi: 10.5539/gjhs.v2n1p106.

  PMID: 21197384 BACKGROUND

• Ricciardolo FL, Gaston B, Hunt J. Acid stress in the pathology of asthma. J Allergy Clin Immunol. 2004 Apr;113(4):610-9. doi: 10.1016/j.jaci.2003.12.034.

  PMID: 15100663 BACKGROUND

• Shin HW, Shelley DA, Henderson EM, Fitzpatrick A, Gaston B, George SC. Airway nitric oxide release is reduced after PBS inhalation in asthma. J Appl Physiol (1985). 2007 Mar;102(3):1028-33. doi: 10.1152/japplphysiol.01012.2006. Epub 2006 Nov 16.

  PMID: 17110506 BACKGROUND

• Hoffmann M, Kleine-Weber H, Schroeder S, Kruger N, Herrler T, Erichsen S, Schiergens TS, Herrler G, Wu NH, Nitsche A, Muller MA, Drosten C, Pohlmann S. SARS-CoV-2 Cell Entry Depends on ACE2 and TMPRSS2 and Is Blocked by a Clinically Proven Protease Inhibitor. Cell. 2020 Apr 16;181(2):271-280.e8. doi: 10.1016/j.cell.2020.02.052. Epub 2020 Mar 5.

  PMID: 32142651 BACKGROUND

• Paget-Brown AO, Ngamtrakulpanit L, Smith A, Bunyan D, Hom S, Nguyen A, Hunt JF. Normative data for pH of exhaled breath condensate. Chest. 2006 Feb;129(2):426-430. doi: 10.1378/chest.129.2.426.

  PMID: 16478862 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Optate; Glycine; Saline Solution

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Amino Acids; Amino Acids, Peptides, and Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Charles Clem

CONTACT

317-274-8899; IUpulm@iupui.edu

Kenzie Mahan

CONTACT

317-274-8899; krmahan@iu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Providing pharmacy will randomize doses and provide blinded doses
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Model Details: 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.

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 5, 2023
• Study Start: June 27, 2023
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

US (1)