Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with COVID-19:Treatment | Experimental | Participants with COVID-19:Treatment - subjects on this treatment arm will receive study drug |
|
| Participants with COVID-19: Placebo | Placebo Comparator | Participants with COVID-19: Placebo - subjects on this arm will get placebo |
|
| Healthy Controls: Treatment | Experimental | Healthy Controls: Treatment - subjects on this treatment arm will receive study drug |
|
| Healthy Controls: Placebo | Placebo Comparator | Healthy Controls: Placebo - subjects on this arm will get placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optate | Drug | Alkaline Buffer |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in SARS-CoV-2 Levels | SARS-CoV-2 levels will be measured in exhaled breath condensate before and one hour after Optate or placebo administration | Immediately before and one-hour after treatment |
| Change in nasal pH |
Not provided
COVID-19 PARTICIPANTS Inclusion Criteria: Subjects, 18 and above, with mild COVID-19 upper respiratory tract infection symptoms
Exclusion Criteria:
HEALTHY CONTROLS Inclusion Criteria: Subjects, 18 and above, without mild COVID-19 upper respiratory tract infection symptoms
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28374138 | Background | 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. | |
| 22877616 | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C000713028 | Optate |
| D005998 | Glycine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
Not provided
Not provided
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.
Not provided
Not provided
Providing pharmacy will randomize doses and provide blinded doses
| Placebo | Drug | Normal Saline |
|
|
Nasal pH will be measured by a nasal pH meter before, immediately after and one hour after Optate or placebo administration
| Immediately before, immediately after and one-hour after treatment |
| 23258576 | 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. |
| 10712309 | 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. |
| 21197384 | 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. |
| 15100663 | 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. |
| 17110506 | 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. |
| 32142651 | 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. |
| 16478862 | 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. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |