COVID-19Phase 2COVD-TXNCT05799521
A Nasal Treatment for COVID-19
A Phase 2 study testing Optate in people with COVID-19 and Healthy, run by Indiana University at 1 site in United States.
Trial summary
The goal of this study is to test an investigational new inhaled medication called Optate. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- What is being tested?
- Optate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2023to 30 Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- 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
- HEALTHY CONTROLS Inclusion Criteria: Subjects, 18 and above, without mild COVID-19 upper respiratory tract infection symptoms
- negative rapid COVID-19 test
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Riley Hospital for Children
Indianapolis, Indiana, 46202
About this study
Official title: A Novel Nasal Treatment for COVID-19
The goal of this study is to test an investigational new inhaled medication called Optate.
Read the 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.
- Being tested
- Optate, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OptateDrug
Also called Glycine
Alkaline Buffer
PlaceboDrug
Also called Normal Saline
Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| Participants with COVID-19:Treatment | Experimental | Participants with COVID-19:Treatment - subjects on this treatment arm will receive study drug Receives: Drug: Optate |
| Participants with COVID-19: Placebo | Placebo comparator | Participants with COVID-19: Placebo - subjects on this arm will get placebo Receives: Drug: Placebo |
| Healthy Controls: Treatment | Experimental | Healthy Controls: Treatment - subjects on this treatment arm will receive study drug Receives: Drug: Optate |
| Healthy Controls: Placebo | Placebo comparator | Healthy Controls: Placebo - subjects on this arm will get placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: Immediately before and 24-hours after treatment
Secondary outcomes (2)
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
Measured: Immediately before and one-hour after treatment
Change in nasal pH
Nasal pH will be measured by a nasal pH meter before, immediately after and one hour after Optate or placebo administration
Measured: Immediately before, immediately after and one-hour after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start27 Jun 2023
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James F. Chmiel, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799521
- Sponsor's protocol ID
- 15989
- Acronym
- COVD-TX
- Status last verified
- May 2026
- First submitted
- 24 Mar 2023
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 28374138Davis 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.
PubMed 22877616Davis 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.
PubMed 23258576Hunt 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.
PubMed 10712309Ngamtrakulpanit 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.
PubMed 21197384Ricciardolo 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.
PubMed 15100663Shin 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.
PubMed 17110506Hoffmann 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.
PubMed 32142651Paget-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.
PubMed 16478862
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Nasal Treatment for COVID-19
- ClinicalTrials.gov ID
- NCT05799521
- Acronym / sponsor ID
- COVD-TX / 15989
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 27 Jun 2023 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Participants with COVID-19:Treatment | Experimental | Drug: OptateParticipants with COVID-19:Treatment - subjects on this treatment arm will receive study drug |
| Participants with COVID-19: Placebo | Placebo comparator | Drug: PlaceboParticipants with COVID-19: Placebo - subjects on this arm will get placebo |
| Healthy Controls: Treatment | Experimental | Drug: OptateHealthy Controls: Treatment - subjects on this treatment arm will receive study drug |
| Healthy Controls: Placebo | Placebo comparator | Drug: PlaceboHealthy Controls: Placebo - subjects on this arm will get placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- 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
- HEALTHY CONTROLS Inclusion Criteria: Subjects, 18 and above, without mild COVID-19 upper respiratory tract infection symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OptateAlso: GlycineAlkaline Buffer | Drug | Healthy Controls: Treatment, Participants with COVID-19:Treatment |
| PlaceboAlso: Normal SalineNormal Saline | Drug | Healthy Controls: Placebo, Participants with COVID-19: Placebo |
Primary outcome
Change in SARS-CoV-2 Levels
Time frame: Immediately before and one-hour after treatment
SARS-CoV-2 levels will be measured in nasal wash before and one hour after Optate or placebo administration
Change in SNOT-22 score
Time frame: Immediately before and one-hour after treatment
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.
Change in SNOT-22 score
Time frame: Immediately before and 24-hours after treatment
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.
2 secondary outcomes
Change in SARS-CoV-2 Levels
Time frame: Immediately before and one-hour after treatment
Change in nasal pH
Time frame: Immediately before, immediately after and one-hour after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Background: PubMed 28374138Davis 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.
- Background: PubMed 22877616Davis 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.
- Background: PubMed 23258576Davis 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.
- Background: PubMed 10712309Hunt 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.
- Background: PubMed 21197384Ngamtrakulpanit 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.
- Background: PubMed 15100663Ricciardolo 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.
- Background: PubMed 17110506Shin 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.
- Background: PubMed 32142651Hoffmann 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.
- Background: PubMed 16478862Paget-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Optate in people with COVID-19 and Healthy, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SARS-CoV-2 Levels (time frame: Immediately before and one-hour after treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05799521, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.