Nasal Treatment for COVID-19

(COVD-TX Trial)

Overseen By Charles Clem

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Indiana University

Disqualifiers: Pregnancy, FEV1 < 55%, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 hour

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new inhaled medication called Optate for treating mild COVID-19 symptoms. Researchers aim to determine if Optate can reduce symptoms such as fever and nasal congestion. Participants will join one of two groups: one receiving Optate and the other a placebo (a non-active substance). Eligible participants must have symptoms like a positive COVID-19 test, fever over 100°F, or nasal congestion. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study showed that Optate is safe and well tolerated in humans. This inhaled treatment works by increasing the pH level on the surface of the airways, which helps stop the COVID-19 virus from multiplying. Research has shown that healthy individuals experienced no serious side effects when using Optate. Lab tests also found it to be non-toxic. Overall, the safety data for Optate appears promising, making it a potential option for those interested in joining a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for COVID-19?

Unlike existing treatments for COVID-19, which often involve oral antivirals or injectable antibodies, Optate is unique because it's delivered as a nasal treatment. This method targets the virus directly at its entry point in the respiratory tract, potentially offering a quicker response in reducing viral load. Researchers are excited about Optate because this direct application might reduce symptoms faster and limit transmission, providing a new tool in the fight against COVID-19.

What evidence suggests that Optate might be an effective treatment for COVID-19?

Research shows that Optate, a new nasal treatment tested in this trial, holds promise in stopping the COVID-19 virus from replicating. In studies with healthy volunteers, Optate almost completely halted the virus's growth at every tested stage. This suggests that Optate could help control the virus in infected individuals. These findings offer hope that Optate might effectively treat COVID-19 by targeting the virus directly in the nose, where it often first enters the body. Participants in this trial will receive either Optate or a placebo to evaluate its effectiveness. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with mild COVID-19 symptoms, a fever above 100°F, nasal congestion, and a positive rapid COVID test. They must be able to follow instructions and use the inhaler correctly. People with severe lung function impairment or more serious illness (OSCI ≥ 3) cannot participate.

Inclusion Criteria

I have had a fever over 100°F.

I am 18 or older with mild COVID-19 symptoms affecting my nose or throat.

Your clinical improvement score is less than 3 on the specific scale mentioned in the appendix.

Exclusion Criteria

Your breathing test shows that you have less than 55% of the expected lung function.

You scored higher than 3 on the Objective Structured Clinical Exam.

I can follow instructions and perform required study procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the investigational nasal treatment Optate or placebo

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Optate
• Placebo

Trial Overview The study is testing Optate, an experimental inhaled medication for treating mild COVID-19 respiratory symptoms. Participants will either receive Optate or a placebo (a treatment without the active drug) to compare effectiveness.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

subjects on Treatment arm will get study drug

Group II: Placebo Placebo Group 1 Intervention

subjects on Treatment arm will get placebo

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Published Research Related to This Trial

In a study of 47 patients who recovered from COVID-19, those using nasal steroids (NSU) experienced less severe and shorter-lasting olfactory and gustatory dysfunction compared to a control group, suggesting a potential benefit of nasal steroids in managing these symptoms.

While nasal steroids did not prevent loss of smell or taste, the NSU group had significantly lower SNOT-22 scores, indicating improved overall nasal health and symptom severity, with a mean duration of dysfunction being shorter in this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of effects of chronic nasal steroid use on rhinological symptoms of COVID-19 with SNOT-22 questionnaire. İşlek, A., Balcı, MK.[2022]

Platelet-rich plasma (PRP) injections have shown promise as a safe and effective treatment for olfactory dysfunction (OD) related to COVID-19, based on a systematic review of four studies involving 233 patients.

The review indicated variable degrees of improvement in olfactory function after PRP treatment, suggesting that while PRP is a potential therapeutic option, further large-scale studies are needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet-rich plasma for the treatment of COVID-19 related olfactory dysfunction: a systematic review. AlRajhi, B., Alrodiman, OA., Alhuzali, AF., et al.[2023]

Nasal delivery methods for COVID-19, including vaccination and antiviral treatments, show promise but often use formulations not optimized for nasal administration, leading to less effective results.

Mechanical barrier and antiviral products have demonstrated effectiveness in preventing or treating early-stage infections, yet they are underutilized in clinical settings, suggesting a need for better development strategies to enhance their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nasal delivery as a strategy for the prevention and treatment of COVID-19. Sonvico, F., Colombo, G., Quarta, E., et al.[2023]

In a study of 100 patients with post COVID-19 anosmia, both the mometasone furoate nasal spray and olfactory training led to significant improvements in smell scores after 3 weeks, but there were no significant differences in effectiveness between the two treatments.

After 3 weeks, 62% of patients using the nasal spray fully recovered their sense of smell compared to 52% using olfactory training alone, indicating that while mometasone furoate may help, it does not provide a clear advantage over olfactory training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Corticosteroid nasal spray for recovery of smell sensation in COVID-19 patients: A randomized controlled trial. Abdelalim, AA., Mohamady, AA., Elsayed, RA., et al.[2022]

'Momate Rhino Advance', a nasal spray combining mometasone furoate and azelastine, is effective for treating moderate to severe allergic rhinitis, allowing for better symptom control.

The treatment strategy involves starting with the combination spray and then transitioning to 'Momate Rhino' alone for 2-4 weeks, which simplifies medication regimens and reduces the need for multiple drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The use of modern topical medications for the stepwise treatment of allergic rhinitis: the effectiveness and prospects for the further extension of their application]. Nosulya, EV., Kim, IA.[2018]

In a study of 150 COVID-19 patients with olfactory dysfunction, those treated with both saline irrigation and the nasal corticosteroid triamcinolone showed significantly improved olfactory function after 30 days compared to those receiving no treatment or only saline irrigation.

Topical triamcinolone was effective in reducing the duration of olfactory dysfunction, highlighting its potential as a safe and low-cost treatment option for patients experiencing smell loss due to COVID-19.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the Healing Effect of Nasal Saline Irrigation with Triamcinolone Acetonide Versus Nasal Saline Irrigation alone in COVID-19 Related Olfactory Dysfunction: A Randomized Controlled Study. Yildiz, E., Koca Yildiz, S., Kuzu, S., et al.[2022]

In a study involving 86 patients with post-COVID-19 olfactory dysfunction, the addition of mometasone nasal spray to olfactory training did not improve the recovery of smell compared to olfactory training alone over a three-month period.

These findings challenge current treatment recommendations for olfactory dysfunction after COVID-19, suggesting that the use of mometasone furoate may not be beneficial and that guidelines may need to be revised.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical Administration of Mometasone Is Not Helpful in Post-COVID-19 Olfactory Dysfunction. Hintschich, CA., Dietz, M., Haehner, A., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7856523/

A Treatment to Eliminate SARS-CoV-2 Replication in ... Healthy human subjects also inhaled Optate as part of a Phase 2a safety trial. RESULTS: Optate almost completely prevented viral replication at each time point ...

2. researchgate.net researchgate.net/publication/344369135_A_treatment_that_eliminates_SARS-CoV-2_replication_in_human_airway_epithelial_cells_and_is_safe_for_inhalation_as_an_aerosol_in_healthy_human_subjects

(PDF) A treatment that eliminates SARS-CoV-2 replication ... Healthy human subjects also inhaled Optate as part of a Phase 2a safety trial. Results: Optate almost completely prevented viral replication ...

3. journals.sagepub.com journals.sagepub.com/doi/full/10.4187/respcare.12580

2023 Year in Review: High-Flow Nasal Cannula for COVID ... This is a review of key peer-reviewed manuscripts from 2022–2023 discussing the efficacy and best practices for using HFNC for patients with ...

4. nature.com nature.com/articles/s41467-021-27318-0

Delayed induction of type I and III interferons mediates ... These data suggest that SARS-CoV-2 may impair, but does not abolish, JAK-STAT signalling in infected cells, implying that recombinant IFNs ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32962996/

A Treatment to Eliminate SARS-CoV-2 Replication in Human ... Healthy human subjects also inhaled Optate as part of a Phase 2a safety trial. Results: Optate almost completely prevented viral replication at each time ...

6. journals.sagepub.com journals.sagepub.com/doi/pdf/10.4187/respcare.08425?download=true

A Treatment to Eliminate SARS-CoV-2 Replication in ... Optate raises intracellular pH and prevents SARS-CoV- 2 replication in NHAE cells. Inhaled Optate raises ALF pH in human subjects, and it is non-toxic in vitro ...

7. scholarworks.indianapolis.iu.edu scholarworks.indianapolis.iu.edu/bitstream/1805/24360/1/Davis2020Treatment.pdf

A treatment that eliminates SARS-CoV-2 replication in human ... Optate is safe and well tolerated in healthy human subjects in vivo and in vitro. Human subjects who inhaled 120 mM Optate had no significant ...

8. scispace.com scispace.com/papers/a-treatment-to-eliminate-sars-cov-2-replication-in-human-1mzncaaf5a

A Treatment to Eliminate SARS-CoV-2 Replication in ... Inhaled Optate is designed to safely raise airway surface pH and is well tolerated in humans. Raising intracellular pH partially prevents activation of SARS-CoV ...