CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 51 enrolled
Drug / intervention
Theophylline Powder +1 moredrug
Likely dose
Theophylline Powder 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04789499
NCT04789499Phase 2Completed
CompareCT.gov

Smell in Covid-19 and Efficacy of Nasal Theophylline

Washington University School of Medicine·interventional·Posted Mar 9, 2021·Updated May 24, 2023

In Brief

A Phase 2 clinical trial evaluating Theophylline Powder and Placebo Comparator for Covid19 and 7 related conditions. Completed, enrolled 51 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCovid19, Anosmia, Olfactory Disorder, Covid-19 Pandemic, SARS-CoV-2 Infection, Hyposmia, Ageusia, Hypogeusia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedMar 9, 2021
Enrollment StartMar 15, 2021
Primary CompletionDec 30, 2021
TodayJul 1, 2026
Enrollment to primary: 10 monthsPosted 5.3 years ago

Interventions

Theophylline Powderdrug

Twice daily nasal irrigation with 400 mg theophylline capsules and USP Grade Sodium Chloride \& Sodium Bicarbonate Mixture (pH balanced, Isotonic \& Preservative \& Iodine Free) commercially prepared packets dissolved in 240 ml of distilled water.

Placebo Comparatordrug

Twice daily nasal irrigation with 500 mg lactose powder capsules and USP Grade Sodium Chloride \& Sodium Bicarbonate Mixture (pH balanced, Isotonic \& Preservative \& Iodine Free) commercially prepared packets dissolved in 240 ml of distilled water.