Trial · NCT04789499
Smell in Covid-19 and Efficacy of Nasal Theophylline
NCT04789499, Phase 2, Completed, Washington University School of Medicine; results first posted 2023-05-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Smell in Covid-19 and Efficacy of Nasal Theophylline. Trials, record NCT04789499. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04789499
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Smell in Covid-19 and Efficacy of Nasal Theophylline
- NCT number
- NCT04789499
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 51 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Covid19, Anosmia, Olfactory Disorder, Covid-19 Pandemic, SARS-CoV-2 Infection, Hyposmia, Ageusia, Hypogeusia
- Interventions
- Theophylline Powder, Placebo Comparator
- First posted
- 2021-03-09
- Last updated
- 2023-05-24
- Results first posted
- 2023-05-24
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | UPSIT | Comparison of response rate at 6 weeks post-intervention from baseline between the 2 study groups | 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 your sense of smell before you started the nasal irrigations, how would you rate your sense of smell now" . Participants reporting 3 as "Minimally Improved", 2 as "Much Improved", or 1 as "Very Much Improved" in the CGI-I will be deemed responders to treatment, and the rate of responders will be compared between the two arms. |
| Secondary | University of Pennsylvania Smell Identification Test (UPSIT) | Comparison at 6 weeks post-intervention from baseline | UPSIT 0-40 with higher scores indicating better smell. This test is an objective, clinically validated 40-question forced-choice odor identification test where microencapsulated odorants on a strip are released by scratching. Out of a total of 40 points, normosmia is defined as ≥34 for males and ≥35 for females, and an increase in ≥4 points will be deemed a clinically significant improvement in symptoms. |
| Secondary | Change in Questionnaire for Olfactory Dysfunction (QOD) From Baseline to 6 Weeks Post Intervention | Comparison at 6 weeks post-intervention from baseline | Questionnaire for Olfactory Dysfunction (QOD) assesses health-related quality of life of participants based on four factors such as eating, mental health, social interactions, or fear of dysfunction.. The survey also includes questions on parosmia, a phenomena of COVID-related OD. The QOD consists of 17 statements that participants score from 0-3, resulting in a total score from 0 to 51. Higher scores reflect better olfactory-specific QOL. |
| Secondary | 36-Item Short Form Health Survey (SF-36) | Baseline assessment | The SF-36 is a well-established 36-item questionnaire evaluating physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. This test allows us to study the overall quality of life for those suffering from COVID-19 related OD. There is no single overall score for SF-36. The SF 36 generates 8 subscales with scores ranging from 0 (worst) to 100 (best). General health domain scores are reported here. |
| Secondary | Olfactory Dysfunction Outcomes Rating (ODOR) | Comparison of response rate at 6 weeks post-intervention from baseline between the 2 study groups | The ODOR is a 28-item QOL instrument with a total score ranging from 0 to 112 points. Higher scores indicate worse QOL with higher degree of dysfunction and limitation. A decrease of 15 or more points is deemed to be a clinically significant improvement in QOL. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | UPSIT | Comparison of response rate at 6 weeks post-intervention from baseline between the 2 study groups | This outcome measure could be assessed only from the participants that completed CGI-I at 6 weeks post intervention. | percentage of participants | NUMBER |
| SECONDARY | University of Pennsylvania Smell Identification Test (UPSIT) | Comparison at 6 weeks post-intervention from baseline | The outcome measure could be assessed only on subjects that completed UPSIT test at 6 weeks post-intervention | score on a scale | MEDIAN |
| SECONDARY | Change in Questionnaire for Olfactory Dysfunction (QOD) From Baseline to 6 Weeks Post Intervention | Comparison at 6 weeks post-intervention from baseline | Since the outcome is measuring the change in QOD, only the data from participant completing QOD at baseline and 6 weeks were included | score on a scale | MEDIAN |
| SECONDARY | 36-Item Short Form Health Survey (SF-36) | Baseline assessment | This was a baseline assessment only, so all randomized participants are analyzed. | score on a scale | MEDIAN |
| SECONDARY | Olfactory Dysfunction Outcomes Rating (ODOR) | Comparison of response rate at 6 weeks post-intervention from baseline between the 2 study groups | This outcome is assessed only for participants that have ODOR assessed at baseline and at 6 months. | score on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| UPSIT | Theophylline | 59 | percentage of participants | ||
| UPSIT | Placebo | 43 | percentage of participants | ||
| University of Pennsylvania Smell Identification Test (UPSIT) | Theophylline | 3 | 95% Confidence Interval -1 to 7 | score on a scale | |
| University of Pennsylvania Smell Identification Test (UPSIT) | Placebo | 0 | 95% Confidence Interval -2 to 6 | score on a scale | |
| Change in Questionnaire for Olfactory Dysfunction (QOD) From Baseline to 6 Weeks Post Intervention | Theophylline | 0.86 | 95% Confidence Interval -0.57 to 2.85 | score on a scale | |
| Change in Questionnaire for Olfactory Dysfunction (QOD) From Baseline to 6 Weeks Post Intervention | Placebo | 1.43 | 95% Confidence Interval -0.29 to 3.14 | score on a scale | |
| 36-Item Short Form Health Survey (SF-36) | Theophylline | 75 | Full Range 40 to 100 | score on a scale | |
| 36-Item Short Form Health Survey (SF-36) | Placebo | 80 | Full Range 50 to 100 | score on a scale | |
| Olfactory Dysfunction Outcomes Rating (ODOR) | Theophylline | -6.5 | 95% Confidence Interval -11.5 to -1.5 | score on a scale | |
| Olfactory Dysfunction Outcomes Rating (ODOR) | Placebo | -4.5 | 95% Confidence Interval -10.5 to 2 | score on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Theophylline | 26 | |
| Overall Study | STARTED | Placebo | 25 | |
| Overall Study | COMPLETED | Theophylline | 22 | |
| Overall Study | COMPLETED | Placebo | 23 | |
| Overall Study | NOT COMPLETED | Theophylline | 4 | |
| Overall Study | NOT COMPLETED | Placebo | 2 |
Source ClinicalTrials.gov
Adverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | fluid retension/extremity swelling | Blood and lymphatic system disorders | Theophylline | 0 | 26 | 0 |
| other | fluid retension/extremity swelling | Blood and lymphatic system disorders | Placebo | 1 | 25 | 1 |
| other | Parosmia and Headache | General disorders | Theophylline | 1 | 26 | 1 |
| other | Parosmia and Headache | General disorders | Placebo | 0 | 25 | 0 |
| other | Lightheadedness | General disorders | Theophylline | 2 | 26 | 2 |
| other | Lightheadedness | General disorders | Placebo | 3 | 25 | 3 |
| other | Nausea | Gastrointestinal disorders | Theophylline | 1 | 26 | 1 |
| other | Nausea | Gastrointestinal disorders | Placebo | 1 | 25 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Theophylline | 1 | 26 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 1 | 25 | 1 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Theophylline | 0 | 26 |
| Total, all-cause mortality | Placebo | 0 | 25 |
| Total, other adverse events | Theophylline | 7 | 26 |
| Total, other adverse events | Placebo | 11 | 25 |
| Total, serious adverse events | Theophylline | 0 | 26 |
| Total, serious adverse events | Placebo | 0 | 25 |
Source ClinicalTrials.gov
Papers46
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Theophylline vs Placebo: deaths from any cause | Trial comparisons |
| Theophylline vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04789499
GET https://conductscience.org/api/trials/v1/NCT04789499/papers?page=2