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NCT05799521 Clinical Trial

A Nasal Treatment for COVID-19

COVID-19 Clinical Trial

— COVD-TX  

Official title:
A Novel Nasal Treatment for COVID-19

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05799521
Other study ID # 15989
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date June 27, 2023
Est. completion date March 30, 2025

Study information
Verified date April 2024
Source Indiana University
Contact Alyssa Laughlin
Phone 317-324-3380
Email IUpulm@iupui.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date March 30, 2025
Est. primary completion date March 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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) - Inability to follow commands or perform study procedures including spirometry, coordinated inhalation of study medication

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Optate
Alkaline Buffer
• Placebo
Normal Saline

Locations
Country Name City State
United States Riley Hospital for Children Indianapolis Indiana

Sponsors (1)
Lead Sponsor Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Measurement of Clinical Respiratory Viral panels and SARS-CoV-2 Levels Clinical respiratory viral panels and SARS-CoV-2 levels will be measured in nasal wash before and one hour after Optate or placebo administration 6 months after enrollment opens
Secondary Survey assessment 3.1.2 SNOT-22 scores (a validated, 22-item quality of life instrument survey) will be assessed immediately prior to Optate or placebo administration. Scores will be reassessed one hour after administration and 24 hours after administration. 6 months after enrollment closes
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