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Intranasal Theophylline for COVID-19
Phase 2
Recruiting
Led By Jay F Piccirillo, MD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up patients may report this information any time during 12 weeks of treatment. they are asked about this at weeks 3, 6, 9, and 12 of treatment.
Awards & highlights
Study Summary
This trial will test an intranasal theophylline rinse to help with smell issues related to COVID-19. Participants will rinse twice daily for 12 weeks and then fill out surveys about smell. Adverse effects will also be monitored.
Who is the study for?
This trial is for adults aged 18-75 in Missouri or Illinois with long-term smell loss after COVID-19. Participants must have a confirmed decrease in smell ability and be able to communicate in English via email. Pregnant women, those on certain medications, or with a history of neurodegenerative diseases or previous nasal surgeries are excluded.Check my eligibility
What is being tested?
The SCENT 3 study tests if rinsing the nose with theophylline (a medication) can improve smell dysfunction related to COVID-19 compared to a placebo rinse. Participants will use these rinses twice daily for 12 weeks and report their sense of smell throughout the study.See study design
What are the potential side effects?
Potential side effects from intranasal theophylline may include local irritation, sneezing, nosebleeds, headaches, or other reactions at the site of application. Systemic side effects are also possible but not specified.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ patients may report this information any time during 12 weeks of treatment. they are asked about this at weeks 3, 6, 9, and 12 of treatment.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patients may report this information any time during 12 weeks of treatment. they are asked about this at weeks 3, 6, 9, and 12 of treatment.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical Global Impression Scale (CGI)
Secondary outcome measures
Adverse effects
Assessment of adherence
Assessment of blind
+1 moreSide effects data
From 2012 Phase 4 trial • 30 Patients • NCT0160113217%
Abdominal pain
17%
Dizziness
14%
Headache
14%
Nausea
7%
Dyspepsia
7%
Diarrhoea
7%
Palpitations
3%
Vomiting
3%
Feeling jittery
3%
Somnolence
100%
80%
60%
40%
20%
0%
Study treatment Arm
Colchicine + Theophylline
Colchicine
Theophylline
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TheophyllineExperimental Treatment1 Intervention
Participants will dissolve the contents of the 400 mg theophylline capsules (experimental) into the sinus rinse bottle containing nasal saline.
Group II: PlaceboPlacebo Group1 Intervention
Participant will dissolve the contents of the identical-appearing lactose capsules (control) into the sinus rinse bottle containing nasal saline.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
theophylline
2005
Completed Phase 4
~290
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,937 Previous Clinical Trials
2,299,455 Total Patients Enrolled
25 Trials studying COVID-19
19,993 Patients Enrolled for COVID-19
Jay F Piccirillo, MDPrincipal InvestigatorWashington University School of Medicine
14 Previous Clinical Trials
626 Total Patients Enrolled
2 Trials studying COVID-19
76 Patients Enrolled for COVID-19
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 75 years old.I rely on theophylline for my asthma or COPD.I have nasal polyps or have had surgery on my nose or skull base.I have not used or been part of trials for intranasal theophylline.You have had an allergic reaction to theophylline or similar medications.Your sense of smell is not as good as it should be, based on a smell test.I am currently using treatments for smell loss.I have a history of a neurodegenerative disease like Alzheimer's or Parkinson's.I am not taking medications that strongly interact with theophylline.I have had a loss of smell for over 3 months after a possible COVID-19 infection.I had issues with my sense of smell before getting COVID-19.
Research Study Groups:
This trial has the following groups:- Group 1: Theophylline
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Theophylline been greenlit by the FDA?
"Based on the available evidence, our team at Power has rated Theophylline as a 2 for safety. This is because there is only preliminary data indicating its safety and no clinical trial results that attest to its effectiveness."
Answered by AI
How many participants will this trial include at its peak?
"Affirmative. According to clinicaltrials.gov, the trial which was first advertised on November 22nd 2022 is actively seeking participants. As of now, 240 individuals need to be recruited from a single medical centre."
Answered by AI
Are there currently any vacancies in the research program?
"Affirmative. According to clinicaltrials.gov, the trial which was initially advertised on November 22nd 2022 is presently recruiting individuals for participation. 240 patients are needed at a single location in order to complete the study effectively and accurately."
Answered by AI
Does the age restriction for this scientific experiment include those over 18 years old?
"This research project is only open to those aged 18 to 75. For younger and older participants, 115 trials and 707 experiments respectively are available for consideration."
Answered by AI
Are there specified criteria which need to be met in order for someone to join this medical study?
"To be eligible for this coronavirus study, applicants must have contracted the virus and fall between 18 to 75 years of age. 240 candidates are being sought after for enrollment in total."
Answered by AI
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