Clinical trial NCT05799521: A Nasal Treatment for COVID-19
Official title: A Novel Nasal Treatment for COVID-19
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2023-04-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: People who test positive for COVID-19
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in SARS-CoV-2 Levels
timeFrame: Immediately before and one-hour after treatment
measure: Change in SNOT-22 score
timeFrame: Immediately before and one-hour after treatment
measure: Change in SNOT-22 score
timeFrame: Immediately before and 24-hours after treatment
Secondary outcomes:
measure: Change in SARS-CoV-2 Levels
timeFrame: Immediately before and one-hour after treatment
measure: Change in nasal pH
timeFrame: Immediately before and one-hour after treatment
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
Study officials:
References:
citation: 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.
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.
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.
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.
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.
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.
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.
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.
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.