Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2023-06-27
2026-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Participants with COVID-19:Treatment
Participants with COVID-19:Treatment - subjects on this treatment arm will receive study drug
Optate
Alkaline Buffer
Participants with COVID-19: Placebo
Participants with COVID-19: Placebo - subjects on this arm will get placebo
Placebo
Normal Saline
Healthy Controls: Treatment
Healthy Controls: Treatment - subjects on this treatment arm will receive study drug
Optate
Alkaline Buffer
Healthy Controls: Placebo
Healthy Controls: Placebo - subjects on this arm will get placebo
Placebo
Normal Saline
Interventions
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Optate
Alkaline Buffer
Placebo
Normal Saline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ordinal Scale for Clinical Improvement \< 3 (OSCI, Appendix 2) and/or
* Fever \> 100 degree F and/or
* Nasal congestion
* 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
* OSCI ≥ 3 (Objective Structured Clinical Exam)
* Pregnancy
* Inability to follow commands or perform study procedures including spirometry, coordinated inhalation of study medication
* Pregnancy
* Inability to follow commands or perform study procedures including spirometry, coordinated inhalation of study medication
18 Years
60 Years
ALL
Yes
Sponsors
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Indiana University
OTHER
Responsible Party
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James F. Chmiel
Professor of Pediatrics
Locations
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Riley Hospital for Children
Indianapolis, Indiana, United States
Countries
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Central Contacts
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Facility Contacts
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Charles Clem
Role: primary
Kenzie Mahan
Role: backup
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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15989
Identifier Type: -
Identifier Source: org_study_id