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NCT04789499 · ClinicalTrials.gov registry record · Phase 2
Smell in Covid-19 and Efficacy of Nasal Theophylline
A Phase 2 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
NCT04789499: Completed Phase 2 study, sponsored by Washington University School of Medicine.
NCT04789499 is a Phase 2 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 51 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04789499, a Phase 2 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
Study Summary
Evidence of COVID-19 related anosmia and dysgeusia continues to accumulate daily. Currently, up to 80% of patients report subjective olfactory dysfunction (OD), and prevalence using objective olfactory testing could be even higher. We propose a phase II single-site, double-blinded, placebo-controlled randomized clinical trial to determine the efficacy and safety of intranasal theophylline, a known phosphodiesterase inhibitor in the treatment of asthma, as a possible treatment for COVID-19 related OD. Theophylline has shown benefit in similar clinical trials for post-viral OD.
Primary Outcome
UPSIT 0-40 with higher scores indicating better results. The response rate defined as the number of participants in each group self-reporting of at least slightly better improvement in the Clinical Global Improvement Scale at 6 weeks post intervention as compared to baseline, devided by the total number of participants in that specific group. The CGI-Improvement Scale has seven response options (from 1 as Very Much Improved to 7 as Very Much Worsened) for answers to the question "Compared to yo
Interventions
- DRUG Placebo Comparator
- DRUG Theophylline Powder
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2021-03-15 |
| Est. Completion | 2021-12-30 |
| Phase | Phase 2 |
What the finished NCT04789499 record still lists
NCT04789499 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo Comparator is the first listed.
NCT04789499 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04789499 about?
NCT04789499 is a clinical study titled "Smell in Covid-19 and Efficacy of Nasal Theophylline". Evidence of COVID-19 related anosmia and dysgeusia continues to accumulate daily. Currently, up to 80% of patients report subjective olfactory dysfunction (OD), and prevalence using objective olfactory testing could be even higher. We propose a phase II single-site, double-blinded, placebo-control...
What is the current status of trial NCT04789499?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2021-03-15. Estimated completion is 2021-12-30.
What interventions are being tested in trial NCT04789499?
The interventions under investigation include: Placebo Comparator (DRUG), Theophylline Powder (DRUG).
Who is sponsoring clinical trial NCT04789499?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04789499's enrollment target sits among peer trials
51 1190th of 2000 higher than 806 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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