COVID-19Phase 2NCT05947643
Smell in COVID-19 and Efficacy of Nasal Theophylline (SCENT 3)
A Phase 2 study testing theophylline in people with COVID-19, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this Phase II trial is to test the effectiveness of intranasal theophylline irrigations for the treatment of COVID-19 related smell dysfunction. The investigators will compare the effect of theophylline nasal rinses versus placebo nasal rinses on smell symptoms. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COVID-19
- What is being tested?
- theophylline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2022to 4 Aug 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will be recruited based on the following inclusion criteria:
- males and females ages 18 to 75 years
- located within or willing to travel to the state of Missouri or Illinois
- Olfactory dysfunction that has persisted for >3 months following suspected COVID-19 infection
- Baseline University of Pennsylvania Smell Identification Test (UPSIT) consistent with decreased olfactory function (<= 34 in women, <=33 in men). This test is a clinically validated 40-question forced-choice odor identification test where microencapsulated odorants on a strip are released by scratching.70 This will determine that patients have both subjectively and objectively diagnosed OD prior to undergoing treatment.
- Ability to read, write, and understand English and have access to email.
Who cannot join
- Individuals will not be allowed to participate in this study if they meet one or more of the following exclusion criteria:
- History of olfactory dysfunction prior to COVID-19 infection
- Any use of concomitant therapies specifically for the treatment of olfactory dysfunction
- Use of or participation in previous trials of intranasal theophylline.
- Known existence of nasal polyps, prior sinonasal, or anterior skull-based surgery
- Dependence on theophylline for comorbid conditions such as asthma and chronic obstructive pulmonary disease (COPD)
Show all 10Show fewer
- History of an allergic reaction to theophylline or other methylxanthines
- History of neurodegenerative disease (ie. Alzheimer's dementia, Parkinson's disease, Lewy body dementia, frontotemporal dementia)
- Pregnant or breastfeeding mothers.
- Current use of medications with significant (≥40%) interactions with theophylline, which include cimetidine, ciprofloxacin, disulfiram, enoxacin, fluvoxamine, interferon- alpha, lithium, mexiletine, phenytoin, propafenone, propranolol, tacrine, thiabendazole, ticlopidine, and troleandomycin.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Smell in COVID-19 and Efficacy of Nasal Theophylline 3
The purpose of this Phase II trial is to test the effectiveness of intranasal theophylline irrigations for the treatment of COVID-19 related smell dysfunction. The investigators will compare the effect of theophylline nasal rinses versus placebo nasal rinses on smell symptoms. Participants will be asked to rinse their nose with a medication or placebo capsule dissolved in saltwater twice daily for 12 weeks and fill out surveys about smell before, during, and at the end of treatment.
This study will also be used to describe adverse effects related to intranasal theophylline irrigation.
Read the detailed description
COVID-related olfactory dysfunction (OD) is a major symptom of infection with SARS-COV-2, affecting up to 80% of those with COVID-19. While research on the pathogenesis is ongoing, a significant subset is expected to suffer from long-term OD. The investigators seek to test intranasal theophylline nasal irrigation as a potential therapeutic option for treatment of COVID-related OD lasting over 3 months.
Theophylline has been shown to improve outcomes in post-viral OD in pilot studies, and initial data suggests therapeutic benefit in patients with post-COVID OD with minimal systemic absorption.
The primary hypothesis is that theophylline irrigation will be more effective than placebo saline irrigation for COVID-19 related OD symptoms. The use of intranasal theophylline will have minimal adverse effects.
- Conditions
- COVID-19
- Being tested
- theophylline, Placebo
- Keywords
- Nasal Theophylline, Olfactory disfunction, Anosmia, Gustatory disorders, Dysgeusia
- Medical subject headings
- COVID-19, Anosmia, Dysgeusia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
theophyllineDrug
capsules dissolved in intranasal irrigation
PlaceboDrug
Also called inactive medicine
identical-appearing lactose capsules dissolved in intranasal irrigation
| Study group | Role | What they receive |
|---|---|---|
| Theophylline | Experimental | Participants will dissolve the contents of the 400 mg theophylline capsules (experimental) into the sinus rinse bottle containing nasal saline. Receives: Drug: theophylline |
| Placebo | Placebo comparator | Participant will dissolve the contents of the identical-appearing lactose capsules (control) into the sinus rinse bottle containing nasal saline. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression - Improvement Scale
The Clinical Global Impression-Improvement scale (CGI-I) is a subjective rating scale used to measure changes in a patient's condition over time. It ranges from 1 to 7, where 1 means "Very Much Improved," 2 means "Much Improved," 3 means "Minimally Improved," 4 means "No Change," 5 means "Minimally Worse," 6 means "Much Worse," and 7 means "Very Much Worsened." In this study, participants reporting scores of 1, 2, or 3 on the CGI-I are considered responders to treatment. The primary analysis will compare the proportion of responders between the theophylline and placebo groups assessing both within-subject changes over time and between-group differences.
We will measure the response rate defined as the number of participants self-reporting minimal change or larger in the Clinical Global Impression Scale (CGI) scale, divided by the number of participants in each group.The main comparison will be focused on changes at 12-weeks
Measured: week 12
Secondary outcomes (4)
Olfactory Dysfunction Outcomes Rating
Olfactory Dysfunction Outcomes Rating (ODOR) is a disease-specific questionnaire that assesses for physical, functional, and emotional limitations in participants with olfactory dysfunction of any etiology. The instrument contains 28 total items with each scored on a 5-point Likert scale from 0 to 4.
Total score ranges from 0 to 112. Higher scores indicate higher degree of dysfunction and limitation.
Measured: 6 weeks and 12 week
Assessment of Adherence
Participants will be contacted to report the number of irrigations completed over the prior 7 days out of a possible 14.
Participants report their compliance with the twice-daily nasal irrigations through self-reported measures in REDCap surveys, including how many rinses they have completed.
The measure count represents the self-reported compliance with twice daily irrigations.
Measured: 12 weeks
Assessment of Blind
The assessment of the blind in this study involves contacting participants within the first 3 weeks after starting nasal irrigations and asking them which treatment arm they believe they were assigned to-either "theophylline and nasal saline irrigation" or "nasal saline irrigation alone."
The numbers reported represent how many participants correctly guessed an arm in which they were assigned to.
Measured: within first 3 weeks
Adverse Effects
Patients will be asked to report any adverse effects they experience at any time during the 12-week study period.
An adverse event in this study refers to any undesirable or unintended medical occurrence experienced by a participant during the trial, which may or may not be related to the use of intranasal theophylline.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start22 Nov 2022
- Primary completion24 Apr 2025
- Study completion4 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (66)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Single-site, double-blinded, placebo-controlled randomized clinical trial performed at a tertiary academic medical center.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jay F Piccirillo, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05947643
- Sponsor's protocol ID
- 202209062
- Status last verified
- Aug 2025
- First submitted
- 13 Jul 2023
- Last updated
- 20 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kaye R, Chang CWD, Kazahaya K, Brereton J, Denneny JC 3rd. COVID-19 Anosmia Reporting Tool: Initial Findings. Otolaryngol Head Neck Surg. 2020 Jul;163(1):132-134. doi: 10.1177/0194599820922992. Epub 2020 Apr 28.
PubMed 32340555Meng X, Deng Y, Dai Z, Meng Z. COVID-19 and anosmia: A review based on up-to-date knowledge. Am J Otolaryngol. 2020 Sep-Oct;41(5):102581. doi: 10.1016/j.amjoto.2020.102581. Epub 2020 Jun 2.
PubMed 32563019Whitcroft KL, Hummel T. Clinical Diagnosis and Current Management Strategies for Olfactory Dysfunction: A Review. JAMA Otolaryngol Head Neck Surg. 2019 Sep 1;145(9):846-853. doi: 10.1001/jamaoto.2019.1728.
PubMed 31318413Dong E, Ratcliff J, Goyea TD, Katz A, Lau R, Ng TK, Garcia B, Bolt E, Prata S, Zhang D, Murray RC, Blake MR, Du H, Ganjkhanloo F, Ahmadi F, Williams J, Choudhury S, Gardner LM. The Johns Hopkins University Center for Systems Science and Engineering COVID-19 Dashboard: data collection process, challenges faced, and lessons learned. Lancet Infect Dis. 2022 Dec;22(12):e370-e376. doi: 10.1016/S1473-3099(22)00434-0. Epub 2022 Aug 31.
PubMed 36057267Menni C, Valdes AM, Polidori L, Antonelli M, Penamakuri S, Nogal A, Louca P, May A, Figueiredo JC, Hu C, Molteni E, Canas L, Osterdahl MF, Modat M, Sudre CH, Fox B, Hammers A, Wolf J, Capdevila J, Chan AT, David SP, Steves CJ, Ourselin S, Spector TD. Symptom prevalence, duration, and risk of hospital admission in individuals infected with SARS-CoV-2 during periods of omicron and delta variant dominance: a prospective observational study from the ZOE COVID Study. Lancet. 2022 Apr 23;399(10335):1618-1624. doi: 10.1016/S0140-6736(22)00327-0. Epub 2022 Apr 7.
PubMed 35397851Chen M, Pekosz A, Villano JS, Shen W, Zhou R, Kulaga H, Li Z, Smith A, Gurung A, Beck SE, Witwer KW, Mankowski JL, Ramanathan M Jr, Rowan NR, Lane AP. Evolution of nasal and olfactory infection characteristics of SARS-CoV-2 variants. J Clin Invest. 2024 Mar 14;134(8):e174439. doi: 10.1172/JCI174439.
PubMed 38483537Sedaghat AR, Gengler I, Speth MM. Olfactory Dysfunction: A Highly Prevalent Symptom of COVID-19 With Public Health Significance. Otolaryngol Head Neck Surg. 2020 Jul;163(1):12-15. doi: 10.1177/0194599820926464. Epub 2020 May 5.
PubMed 32366160Moein ST, Hashemian SM, Mansourafshar B, Khorram-Tousi A, Tabarsi P, Doty RL. Smell dysfunction: a biomarker for COVID-19. Int Forum Allergy Rhinol. 2020 Aug;10(8):944-950. doi: 10.1002/alr.22587. Epub 2020 Jun 18.
PubMed 32301284Menni C, Sudre CH, Steves CJ, Ourselin S, Spector TD. Quantifying additional COVID-19 symptoms will save lives. Lancet. 2020 Jun 20;395(10241):e107-e108. doi: 10.1016/S0140-6736(20)31281-2. Epub 2020 Jun 4. No abstract available.
PubMed 32505221Carfi A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603.
PubMed 32644129Tan BKJ, Han R, Zhao JJ, Tan NKW, Quah ESH, Tan CJ, Chan YH, Teo NWY, Charn TC, See A, Xu S, Chapurin N, Chandra RK, Chowdhury N, Butowt R, von Bartheld CS, Kumar BN, Hopkins C, Toh ST. Prognosis and persistence of smell and taste dysfunction in patients with covid-19: meta-analysis with parametric cure modelling of recovery curves. BMJ. 2022 Jul 27;378:e069503. doi: 10.1136/bmj-2021-069503.
PubMed 35896188Whitcroft KL, Hummel T. Olfactory Dysfunction in COVID-19: Diagnosis and Management. JAMA. 2020 Jun 23;323(24):2512-2514. doi: 10.1001/jama.2020.8391. No abstract available.
PubMed 32432682Catton G, Gardner A. COVID-19 Induced Taste Dysfunction and Recovery: Association with Smell Dysfunction and Oral Health Behaviour. Medicina (Kaunas). 2022 May 26;58(6):715. doi: 10.3390/medicina58060715.
PubMed 35743978Sungnak W, Huang N, Becavin C, Berg M, Queen R, Litvinukova M, Talavera-Lopez C, Maatz H, Reichart D, Sampaziotis F, Worlock KB, Yoshida M, Barnes JL; HCA Lung Biological Network. SARS-CoV-2 entry factors are highly expressed in nasal epithelial cells together with innate immune genes. Nat Med. 2020 May;26(5):681-687. doi: 10.1038/s41591-020-0868-6. Epub 2020 Apr 23.
PubMed 32327758Rockx B, Kuiken T, Herfst S, Bestebroer T, Lamers MM, Oude Munnink BB, de Meulder D, van Amerongen G, van den Brand J, Okba NMA, Schipper D, van Run P, Leijten L, Sikkema R, Verschoor E, Verstrepen B, Bogers W, Langermans J, Drosten C, Fentener van Vlissingen M, Fouchier R, de Swart R, Koopmans M, Haagmans BL. Comparative pathogenesis of COVID-19, MERS, and SARS in a nonhuman primate model. Science. 2020 May 29;368(6494):1012-1015. doi: 10.1126/science.abb7314. Epub 2020 Apr 17.
PubMed 32303590
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smell in COVID-19 and Efficacy of Nasal Theophylline 3
- ClinicalTrials.gov ID
- NCT05947643
- Acronym / sponsor ID
- 202209062
- Conditions
- COVID-19
- Keywords
- Nasal Theophylline, Olfactory disfunction, Anosmia, Gustatory disorders, Dysgeusia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 24 Apr 2025 (actual)
- Study completion
- 4 Aug 2025 (actual)
- First posted
- 17 Jul 2023 (actual)
- Results
- Posted 20 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this Phase II trial is to test the effectiveness of intranasal theophylline irrigations for the treatment of COVID-19 related smell dysfunction. The investigators will compare the effect of theophylline nasal rinses versus placebo nasal rinses on smell symptoms. Participants will be asked to rinse their nose with a medication or placebo capsule dissolved in saltwater twice daily for 12 weeks and fill out surveys about smell before, during, and at the end of treatment.
This study will also be used to describe adverse effects related to intranasal theophylline irrigation.
Detailed description
COVID-related olfactory dysfunction (OD) is a major symptom of infection with SARS-COV-2, affecting up to 80% of those with COVID-19. While research on the pathogenesis is ongoing, a significant subset is expected to suffer from long-term OD. The investigators seek to test intranasal theophylline nasal irrigation as a potential therapeutic option for treatment of COVID-related OD lasting over 3 months.
Theophylline has been shown to improve outcomes in post-viral OD in pilot studies, and initial data suggests therapeutic benefit in patients with post-COVID OD with minimal systemic absorption.
The primary hypothesis is that theophylline irrigation will be more effective than placebo saline irrigation for COVID-19 related OD symptoms. The use of intranasal theophylline will have minimal adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Single-site, double-blinded, placebo-controlled randomized clinical trial performed at a tertiary academic medical center.
| Arm | Type | Receives |
|---|---|---|
| Theophylline | Experimental | Drug: theophyllineParticipants will dissolve the contents of the 400 mg theophylline capsules (experimental) into the sinus rinse bottle containing nasal saline. |
| Placebo | Placebo comparator | Drug: PlaceboParticipant will dissolve the contents of the identical-appearing lactose capsules (control) into the sinus rinse bottle containing nasal saline. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants will be recruited based on the following inclusion criteria:
Key exclusion criteria (10 listed)
- Individuals will not be allowed to participate in this study if they meet one or more of the following exclusion criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| theophyllinecapsules dissolved in intranasal irrigation | Drug | Theophylline |
| PlaceboAlso: inactive medicineidentical-appearing lactose capsules dissolved in intranasal irrigation | Drug | Placebo |
Primary outcome
Clinical Global Impression - Improvement Scale
Time frame: week 12
The Clinical Global Impression-Improvement scale (CGI-I) is a subjective rating scale used to measure changes in a patient's condition over time. It ranges from 1 to 7, where 1 means "Very Much Improved," 2 means "Much Improved," 3 means "Minimally Improved," 4 means "No Change," 5 means "Minimally Worse," 6 means "Much Worse," and 7 means "Very Much Worsened." In this study, participants reporting scores of 1, 2, or 3 on the CGI-I are considered responders to treatment. The primary analysis will compare the proportion of responders between the theophylline and placebo groups assessing both within-subject changes over time and between-group differences. We will measure the response rate defined as the number of participants self-reporting minimal change or larger in the Clinical Global Impression Scale (CGI) scale, divided by the number of participants in each group.The main comparison will be focused on changes at 12-weeks
4 secondary outcomes
Olfactory Dysfunction Outcomes Rating
Time frame: 6 weeks and 12 week
Assessment of Adherence
Time frame: 12 weeks
Assessment of Blind
Time frame: within first 3 weeks
Adverse Effects
Time frame: up to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32340555Kaye R, Chang CWD, Kazahaya K, Brereton J, Denneny JC 3rd. COVID-19 Anosmia Reporting Tool: Initial Findings. Otolaryngol Head Neck Surg. 2020 Jul;163(1):132-134. doi: 10.1177/0194599820922992. Epub 2020 Apr 28.
- Background: PubMed 32563019Meng X, Deng Y, Dai Z, Meng Z. COVID-19 and anosmia: A review based on up-to-date knowledge. Am J Otolaryngol. 2020 Sep-Oct;41(5):102581. doi: 10.1016/j.amjoto.2020.102581. Epub 2020 Jun 2.
- Background: PubMed 31318413Whitcroft KL, Hummel T. Clinical Diagnosis and Current Management Strategies for Olfactory Dysfunction: A Review. JAMA Otolaryngol Head Neck Surg. 2019 Sep 1;145(9):846-853. doi: 10.1001/jamaoto.2019.1728.
- Background: PubMed 36057267Dong E, Ratcliff J, Goyea TD, Katz A, Lau R, Ng TK, Garcia B, Bolt E, Prata S, Zhang D, Murray RC, Blake MR, Du H, Ganjkhanloo F, Ahmadi F, Williams J, Choudhury S, Gardner LM. The Johns Hopkins University Center for Systems Science and Engineering COVID-19 Dashboard: data collection process, challenges faced, and lessons learned. Lancet Infect Dis. 2022 Dec;22(12):e370-e376. doi: 10.1016/S1473-3099(22)00434-0. Epub 2022 Aug 31.
- Background: PubMed 35397851Menni C, Valdes AM, Polidori L, Antonelli M, Penamakuri S, Nogal A, Louca P, May A, Figueiredo JC, Hu C, Molteni E, Canas L, Osterdahl MF, Modat M, Sudre CH, Fox B, Hammers A, Wolf J, Capdevila J, Chan AT, David SP, Steves CJ, Ourselin S, Spector TD. Symptom prevalence, duration, and risk of hospital admission in individuals infected with SARS-CoV-2 during periods of omicron and delta variant dominance: a prospective observational study from the ZOE COVID Study. Lancet. 2022 Apr 23;399(10335):1618-1624. doi: 10.1016/S0140-6736(22)00327-0. Epub 2022 Apr 7.
- Background: PubMed 38483537Chen M, Pekosz A, Villano JS, Shen W, Zhou R, Kulaga H, Li Z, Smith A, Gurung A, Beck SE, Witwer KW, Mankowski JL, Ramanathan M Jr, Rowan NR, Lane AP. Evolution of nasal and olfactory infection characteristics of SARS-CoV-2 variants. J Clin Invest. 2024 Mar 14;134(8):e174439. doi: 10.1172/JCI174439.
- Background: PubMed 32366160Sedaghat AR, Gengler I, Speth MM. Olfactory Dysfunction: A Highly Prevalent Symptom of COVID-19 With Public Health Significance. Otolaryngol Head Neck Surg. 2020 Jul;163(1):12-15. doi: 10.1177/0194599820926464. Epub 2020 May 5.
- Background: PubMed 32301284Moein ST, Hashemian SM, Mansourafshar B, Khorram-Tousi A, Tabarsi P, Doty RL. Smell dysfunction: a biomarker for COVID-19. Int Forum Allergy Rhinol. 2020 Aug;10(8):944-950. doi: 10.1002/alr.22587. Epub 2020 Jun 18.
- Background: PubMed 32505221Menni C, Sudre CH, Steves CJ, Ourselin S, Spector TD. Quantifying additional COVID-19 symptoms will save lives. Lancet. 2020 Jun 20;395(10241):e107-e108. doi: 10.1016/S0140-6736(20)31281-2. Epub 2020 Jun 4. No abstract available.
- Background: PubMed 32644129Carfi A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603.
- Background: PubMed 35896188Tan BKJ, Han R, Zhao JJ, Tan NKW, Quah ESH, Tan CJ, Chan YH, Teo NWY, Charn TC, See A, Xu S, Chapurin N, Chandra RK, Chowdhury N, Butowt R, von Bartheld CS, Kumar BN, Hopkins C, Toh ST. Prognosis and persistence of smell and taste dysfunction in patients with covid-19: meta-analysis with parametric cure modelling of recovery curves. BMJ. 2022 Jul 27;378:e069503. doi: 10.1136/bmj-2021-069503.
- Background: PubMed 32432682Whitcroft KL, Hummel T. Olfactory Dysfunction in COVID-19: Diagnosis and Management. JAMA. 2020 Jun 23;323(24):2512-2514. doi: 10.1001/jama.2020.8391. No abstract available.
- Anosmia Rehabilitation in Patients Post Coronavirus Disease (COVID 19).Link provided by the sponsor.
- COVID-19 Anosmia Study.Link provided by the sponsor.
- Corticosteroid Nasal Spray in COVID-19 Anosmia.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jay F Piccirillo, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing theophylline in people with COVID-19, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Global Impression - Improvement Scale (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05947643, which also lists 66 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.