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

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the drug Optate for COVID-19?

The study on nasal saline irrigation with triamcinolone acetonide, a type of corticosteroid, showed that it significantly improved the sense of smell in COVID-19 patients compared to saline alone or no treatment. This suggests that nasal corticosteroids can be effective in treating COVID-19 related olfactory dysfunction. ^{1 2 3 4 5}

How is the drug Optate different from other COVID-19 treatments?

Optate is unique because it is administered nasally, targeting the upper respiratory tract, which is a major route of COVID-19 infection. This approach aims to prevent or minimize the spread of the virus directly at the site of entry, unlike many other treatments that are systemic (affecting the whole body). ^{2 3 4 6 7}

What is the purpose of this trial?

The goal of this study is to test an investigational new inhaled medication called Optate.

Eligibility Criteria

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.

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

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

'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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Platelet-rich plasma for the treatment of COVID-19 related olfactory dysfunction: a systematic review. [2023]

2. India 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. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Topical Administration of Mometasone Is Not Helpful in Post-COVID-19 Olfactory Dysfunction. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Corticosteroid nasal spray for recovery of smell sensation in COVID-19 patients: A randomized controlled trial. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

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

6. Russia (Federation) 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]. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Nasal delivery as a strategy for the prevention and treatment of COVID-19. [2023]