Astepro® Nasal Spray for COVID-19

(COVID-19 Trial)

Overseen By Julian Solway

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Chicago

Must not be taking: Steroids, Immunomodulators, others

Disqualifiers: Pregnancy, Unvaccinated, Moderate Covid, others

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

Compensation: Varies

Number of Visits: 13

Duration: 10 days

280 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of Astepro® 0.15% nasal spray against COVID-19 in adults. Participants will receive either the nasal spray or a placebo (a treatment with no active drug) to compare results. The trial targets individuals with mild or no symptoms of COVID-19 who have tested positive, or close contacts of those individuals. Eligible participants must be vaccinated against COVID-19 and able to provide saliva samples and report symptoms during the study. As a Phase 4 trial, this research aims to understand how the already FDA-approved treatment benefits more patients.

Will I have to stop taking my current medications?

The trial requires that you stop using certain medications, such as other Covid-19 treatments and any intranasal, corticosteroid, or immunomodulator medications that could affect the study drug, Astepro.

What is the safety track record for Astepro® Nasal Spray?

Research shows that azelastine nasal spray, the main ingredient in Astepro®, is generally safe for patients. Studies indicate it can lower the amount of virus in people with confirmed COVID-19. In one study, only 1.8% of patients using the nasal spray contracted a cold virus, compared to 6.3% of those using a placebo. This suggests the spray might help prevent infections.

Regarding safety, earlier studies found that serious side effects are rare. Most side effects are mild, such as a bitter taste or slight nose discomfort. Since Astepro® is already approved for treating allergies, this adds confidence about its safety for other uses.

Overall, the evidence so far supports that azelastine nasal spray is safe for people, with only minor side effects reported. ^{1 2 3 4}

Why are researchers enthusiastic about this study treatment?

Unlike the standard of care for COVID-19, which often involves antiviral medications and supportive treatments, Astepro® nasal spray introduces a unique approach by using azelastine, an antihistamine commonly found in allergy medications. Researchers are excited about this treatment because it is delivered directly to the nasal passages, potentially reducing viral load where the virus first enters the body. This localized delivery could lead to faster symptom relief and help prevent the virus from spreading within the body. The use of azelastine, an established antihistamine, also offers a novel mechanism in the fight against COVID-19, breaking away from traditional antiviral strategies.

What evidence suggests that Astepro® nasal spray could be an effective treatment for COVID-19?

Research has shown that azelastine nasal spray, also known as Astepro®, may reduce the amount of virus in people with confirmed COVID-19. Studies have found that it can lower the risk of respiratory symptoms related to the virus. One study found that using azelastine nasal spray could reduce the chance of getting a COVID-19 infection by about 67%. These findings suggest that Astepro® might help manage COVID-19 symptoms and possibly prevent the virus. In this trial, participants will receive either the Astepro® nasal spray or a placebo to evaluate its effectiveness specifically for COVID-19. While proven effective for other conditions, these results are promising for its use in treating COVID-19. ^{1 2 3 5 6}

Who Is on the Research Team?

Brandon Baird

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for adults with a positive COVID-19 test who can provide saliva samples every other day for 10 days and report symptoms. Participants should have mild or no symptoms, be able to follow study instructions, and not use other COVID treatments during the study. Vaccinated individuals are eligible.

Inclusion Criteria

I have mild or no symptoms of Covid-19.

You have tested positive for COVID-19 before starting the treatment.

I have been vaccinated for Covid-19.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive Astepro® 0.15% nasal spray or placebo for 10 days to manage Covid-19 symptoms and assess viral load

10 days

Self-collected samples over 10 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of Covid-19 infectivity in close contacts

1 week

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Experimental
• Placebo Comparator

Trial Overview The University of Chicago is testing Astepro® 0.15% nasal spray's effectiveness against early SARS-CoV-2 infection in adults compared to a placebo. The goal is to see if this treatment can manage the virus effectively.

How Is the Trial Designed?

Group I: Primary Cohort - Azelastine Experimental Treatment 1 Intervention

This is a double-blind clinical trial. All subjects will be sent an instructional video and be given written instructions which will educate them on how to use the drug or placebo nasal spray. Patients will follow the dosing instructions for Astepro® 0.15% nasal spray.

Group II: Primary Cohort - Placebo Placebo Group 1 Intervention

This is a double-blind clinical trial. A Placebo will be provided by Bayer which features similar color and packaging. Both groups will also undergo recommendations for supportive care, which will be standardized. Any patients who develop severe disease will be given instructions for escalation of care.

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Published Research Related to This Trial

The Lupus Intervention Fatigue Trial (LIFT) is a randomized controlled trial involving 236 participants aimed at reducing fatigue in individuals with systemic lupus erythematosus (SLE) through a six-month motivational interviewing program compared to an educational control.

The primary outcome of the study is the change in fatigue levels measured by the Fatigue Severity Score after six months, with additional assessments of physical activity and dietary adherence, which will help develop future strategies for managing fatigue in SLE patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational interviewing intervention for increasing physical activity and improving dietary behaviors: The Lupus Intervention Fatigue Trial protocol. Kinnett-Hopkins, D., Ehrlich-Jones, L., Chmiel, JS., et al.[2023]

Two patients with systemic lupus erythematosus (SLE) and low disease activity experienced significant improvements in fatigue scores after treatment with modafinil, a central nervous system stimulant, indicating its potential efficacy for lupus-associated fatigue (LAF).

The first patient improved from a FACIT fatigue score of 15 to 42, and the second from 20 to 37, suggesting that modafinil may be a viable pharmacological option for managing LAF, although further clinical trials are needed to validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement of lupus-associated fatigue with modafinil: Report of two cases. Korsten, P., Piantoni, S.[2021]

Most randomized clinical trials for biological therapies in systemic lupus erythematosus (SLE) have not met their primary efficacy endpoints, often due to a lack of focus on patient-reported outcomes (PROs) that reflect symptoms important to patients, like fatigue.

The review highlights the importance of incorporating PROs and health-related quality of life (HRQoL) measures in evaluating the effectiveness of biological therapies, suggesting that a combination of generic and disease-specific measures is necessary to fully capture the patient perspective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do biological agents improve health-related quality of life in patients with systemic lupus erythematosus? Results from a systematic search of the literature. Gomez, A., Parodis, I.[2022]

In a study of 515 systemic lupus erythematosus (SLE) patients, factors such as Caucasian ethnicity, pain levels, abnormal illness-related behaviors, and feelings of helplessness were linked to increased fatigue, highlighting the importance of psychological and social factors in managing fatigue.

Interestingly, traditional SLE-specific measures like disease activity and damage did not correlate with fatigue levels, suggesting that interventions to reduce fatigue should focus on addressing pain and psychological well-being rather than just disease severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disease activity and damage are not associated with increased levels of fatigue in systemic lupus erythematosus patients from a multiethnic cohort: LXVII. Burgos, PI., Alarcón, GS., McGwin, G., et al.[2022]

In a Phase IIb trial involving 305 patients with systemic lupus erythematosus (SLE), anifrolumab treatment led to a higher rate of achieving the Lupus Low Disease Activity State (LLDAS) compared to placebo, indicating its efficacy in managing SLE symptoms.

The study found that anifrolumab-treated patients not only reached LLDAS earlier but also spent more time in this state, supporting the use of LLDAS as a meaningful endpoint in SLE clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lupus Low Disease Activity State (LLDAS) attainment discriminates responders in a systemic lupus erythematosus trial: post-hoc analysis of the Phase IIb MUSE trial of anifrolumab. Morand, EF., Trasieva, T., Berglind, A., et al.[2019]

Citations

1. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2838335

Azelastine Nasal Spray for Prevention of SARS-CoV-2 ... Randomized clinical trials have demonstrated that azelastine nasal spray reduces viral load in patients with laboratory-confirmed SARS-CoV-2 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40892398/

Azelastine Nasal Spray for Prevention of SARS-CoV-2 ... Conclusions and relevance: In this single-center trial, azelastine nasal spray was associated with reduced risk of SARS-CoV-2 respiratory ...

3. cidrap.umn.edu cidrap.umn.edu/covid-19/antihistamine-nasal-spray-prevents-covid-19-study-finds

Antihistamine nasal spray prevents COVID-19, study finds "These results suggest that azelastine may provide meaningful protection against SARS-CoV-2 infection in a prophylactic setting," the authors ...

4. chestphysician.org chestphysician.org/azelastine-nasal-spray-shows-promise-in-preventing-sars-cov-2-infections/

Azelastine nasal spray shows promise in preventing SARS ... Azelastine nasal spray shows promise in preventing SARS-CoV-2 infections. Results from a phase 2, double-blind, placebo-controlled, single- ...

5. youtube.com youtube.com/watch?v=lrn8HkAQ0jQ

RCT: Azelastine Nasal Spray Reduces COVID by 67% Taking this nasal spray can actually reduce your chances of getting SARS KV2 infections by 67.3%.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06008860

A Pilot Clinical Evaluation of Astepro® Nasal Spray for ... In this study, the study team aims to re-confirm the utility of this medication for use in Covid-19 to decrease the significant impact on quality of life, ...