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

Trial Summary

What is the purpose of this trial?

The study team proposes to evaluate the efficacy of Astepro® 0.15% nasal spray in treating SARS-CoV-2 infection in adults through a pilot and feasibility clinical trial at the University of Chicago.

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.

How does Astepro® Nasal Spray for COVID-19 differ from other treatments?

Astepro® Nasal Spray is unique because it is administered as a nasal spray, which is different from the more common oral or injectable treatments for COVID-19. This method of delivery could potentially offer a more direct effect on the nasal passages, where the virus often enters the body. ^{1 2 3 4 5}

Research Team

Brandon Baird

Principal Investigator

University of Chicago

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Improvement of lupus-associated fatigue with modafinil: Report of two cases. [2021]

2. Netherlands 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. [2022]

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

Motivational interviewing intervention for increasing physical activity and improving dietary behaviors: The Lupus Intervention Fatigue Trial protocol. [2023]

4. England 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. [2019]

5. United States 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. [2022]