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Smell in Covid-19 and Efficacy of Nasal Theophylline

NCT04789499 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2023-05-24

Study results available
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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.

Conditions

  • Covid19
  • Anosmia
  • Olfactory Disorder
  • Covid-19 Pandemic
  • SARS-CoV-2 Infection
  • Hyposmia
  • Ageusia
  • Hypogeusia

Interventions

DRUG

Theophylline Powder

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.

DRUG

Placebo Comparator

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.

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Jay F Piccirillo, M.D., FACS · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-15
Primary Completion
2021-12-30
Completion
2021-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04789499 on ClinicalTrials.gov