Clinical TrialID 6606
Smell in Covid-19 and Efficacy of Nasal Theophylline
NCT04789499
Covid19|Anosmia|Olfactory Disorder|Covid-19 Pandemic|SARS-CoV-2 Infection|Hyposmia|Ageusia|Hypogeusia
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 6606
- Evidence Id
- 6606
- Core Evidence Id
- 6606
- Source Clinical Trial Id
- 6593
- Herb2 Clinical Trial Id
- HBCT006593
- Nct Id
- NCT04789499
- Title
- Smell in Covid-19 and Efficacy of Nasal Theophylline
- Status
- Completed
- Phase
- Phase 2
- Study Result
- Yes
- Study Condition
- Covid19|Anosmia|Olfactory Disorder|Covid-19 Pandemic|SARS-CoV-2 Infection|Hyposmia|Ageusia|Hypogeusia
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
- Intervention
- DRUG: Theophylline Powder|DRUG: Placebo Comparator
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Double
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 51
- Outcome Measure
- UPSIT, 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., Comparison of response rate at 6 weeks post-intervention from baseline between the 2 study groups
- Sponsor Collaborator
- Washington University School of Medicine
- Funded By
- OTHER
- Location
- Washington University School of Medicine in Saint Louis, Saint Louis, Missouri, 63110, United States
- Other Id
- 202101190
- Start Date
- 2021-03-15
- Primary Completion Date
- 2021-12-30
- Completion Date
- 2021-12-30
- First Posted
- 2021-03-09
- Results First Posted
- 2023-05-24
- Last Update Posted
- 2023-05-24
- Study Document
- Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/99/NCT04789499/Prot_SAP_000.pdf
- Study Url
- https://clinicaltrials.gov/study/NCT04789499
- Title Cn
- Title En
- Smell in Covid-19 and Efficacy of Nasal Theophylline
- Bilingual Status
- semi_complete