An observational study in Chronic Rhinosinusitis (Diagnosis), COVID-19 and Anosmia, sponsored by University of Aarhus. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-07.
Sponsored by University of Aarhus · Observational
Among 99 studies in COVID-19 with a site in Denmark — 11 open to participants now, 13 under way, 3 of them phase 3. COVID-19 · Denmark.
Among the 99 studies in COVID-19 with a site in Denmark, this one is the 19th largest by planned enrollment of the 43 observational ones, is one of 55 that started in 2020, is one of 43 observational ones, reaches primary completion later than 8 of the 12 other live ones, and was the 66th registered.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's planned enrollment of 619 is above the median of 268 across 3,208 observational studies indexed under COVID-19.
Browse COVID-19 studies →11 of the 99 studies in COVID-19 with a site in Denmark are open now, in 12 countries. Each count lists the studies.
Of the 356 COVID-19 studies recruiting now, 207 (58%) set no upper age limit and 83 (23%) stop at 75 or younger; 91 take children under 18; 136 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →99 studies; the count open now beside each. This study's row is marked.
First in 2017; this study’s year is marked. 55 started in 2020.
Median enrollment 317 across the 55 interventional studies, 417 across the 43 observational. Of the 69 that completed or were terminated, 20 (29%) have results posted.
14 of 99 have an industry lead sponsor. The 10 most frequent:
University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.
University of Aarhus has 4 studies filed under COVID-19 — fewer than ten, so there is no comparison to draw.
3 of the studies in COVID-19 with a site in Denmark that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07013474Phase 3PfizerA Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised | 2027-09-28 |
| NCT06679140Phase 3PfizerA Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease | 2027-10-01 |
| NCT05624450Phase 3AstraZenecaEfficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen | 2027-11-04 |
Among the 99 studies in COVID-19 with a site in Denmark, from their registry updates:
Methods: all studies are case control studies on six different groups: normal individuals, non-COVID-19 patients with olfactory dysfunction, COVID-19 positive patients, previous COVID-19 positive patients with prolonged olfactory dysfunction, patients with chronic rhinosinusitis with and without nasal polyps, and patients with CRS initiating intranasal glucocorticoids.. The patients will be included from the ear-, nose, and throat department and the University Clinic for Flavour, Balance, and Sleep Regional Hospital Gødstrup, as well as Flavour Institute, Department of Clinical Medicine, Aarhus University (AU), and the long COVID-19 clinics in Aarhus and Gødstrup.
Microbiome samples will be swabs from the nasal cavity and oral pharynx will be collected and analysed using next-generation sequencing targeting 16S and 18S ribosomal RNA at the Department of Bacteria, Parasite \& Fungi at Staten Serum Institute (SSI), Copenhagen, Denmark. Characterization of the microbiome is performed by 16S/18S amplicon-based metagenomics, and data are analyzed by various bio-informatic tools for determination/visualization of alpha/beta diversity as well as principal coordinates analysis (PCoA). Immunological factors will be collected by means of six swabs: in the nasal cavity and used for either flowcytometry or enzyme-linked immunosorbent assay (ELISA).
For comparison, truecut biopsies of the nasal mucosa are collected from a subgroup of patients undergoing surgery in general anaesthesia.
Due to the novelty of the current study, little relevant information from previous literature can be used for power calculation. However, with an alpha of 5% and a power of 80%, the population size for each group should be 42 participants, assuming the occurrence of bacteria differs with 30% between populations. Taking 20% drop out into account, the investigators aim to include 60 patients in each group.
Perspectives:
The perspectives of this study is to begin bridging the gap between gut and upper airway microbiome and immunology research. Looking at the explosion of interest in the gut, and in personalized medicine in general, the investigators likewise foresee a huge potential for both general and individual prevention and treatments starting with a deeper understanding of the nasal microbiome and immunology. Examples beyond the scope of this study could be microbiome transplants for chronic sufferers of diseases such as chronic rhinosinusitis, allergies or asthma, or in selecting which patients could reap the benefits of the expensive biological treatments emerging on the market.
Hypotheses
The following null hypotheses are suggested:
Populations:
Inclusion criteria
Exclusion criteria
Recruitment: Population 1, 5, and 6 are recruited among patients undergoing sino-nasal surgery at the ear-nose-throat department, Regional Hospital Gødstrup, Denmark. Populations 2 and 4 are enrolled from the Flavour Institute, Department of Clinical Medicine, Aarhus University, Denmark, and University Clinic for Flavour, Balance, and Sleep, Gødstrup Regional Hospital, Denmark. Popu-lation 3 is recruited at the long COVID-19 clinics at Aarhus University Hospital and at Gødstrup Regional Hospital. Population 1 will be supplied with staff members and university students.
Clinical examinations, measurements and information: For all participants, information is ob-tained on medical history, medicine use, objective ear, nose, and throat examination including endoscopy of upper airways, Sino-Nasal Outcome Test-22[9], Major Depression Inventory[10,11], Mini Mental Status[12], Sniffin' Sticks[13], and taste screening.
Microbiome samples: Swabs from the nasal cavity and oral pharynx will be collected for microbi-ome analysis using next-generation sequencing targeting 16S and 18S ribosomal RNA. Characteri-zation of the microbiome is performed by 16S/18S amplicon-based metagenomics, and data are analyzed by various bioinformatic tools for determination/visualization of alpha/beta diversity as well as principal coordinates analysis (PCoA).
Intranasal immune factors: Nasal biopsies (3x3x3 mm) will be characterized histologically and analysed using spatial transcriptomics on the Vision 10X Genomics platform. Nasal secretion is collected by means of six swabs and used to characterize the cytokine profile. A broad Luminex-based panel encompassing 45 cytokines and chemokines will be employed (Invitrogen, Cyto-kine/Chemokine/Growth Factor Convenience 45-Plex Human ProcartaPlex™ Panel 1), and samples will be run in duplicate. The panel includes cytokines known to play a role in CRS, and which are targeted by biologic treatment, such as IL-4, IL-13, and IL-5.
Data on nasal steroid use: Patients starting intranasal glucocorticoids will be included upon com-mencement of treatment and follow up will be after 24 weeks.
Statistics: With an alpha of 5% and a power of 80%, the population size for each group should be 42 participants, assuming the occurrence of bacteria differs with 30% between populations. Tak-ing 20% drop out into account, the investigators aim to include 60 patients in group 1-4. The studies involving group 5 and 6 are explorative and hypothesis-generating, and power calculations have not been performed. Furthermore, only few patients fulfil the criteria for biological treatment; hence the investigators intend to include all patients initiating biological treatment within 12-18 months.
Feasibility: The project is a collaboration between the applicant; professor, senior consultant, DMSc, Therese Ovesen, Flavour Institute, Aarhus University \& The Flavour Clinic, Gødstrup Re-gional Hospital; and senior consultant, DMSc, Kurt Fuursted, Statens Serum Institute (SSI). The Flavour Institute, receives patients from all over Denmark, and since 2015 almost 3000 patients have consulted the unit, and more than 50 research studies of olfactory dysfunction have been published from the Flavour Clinic and Institute. Since 2016, routine clinical microbiome diagnos-tics, 16S/18S amplicon-based metagenomics, has been conducted at SSI, and both clinical and bioinformatic expertise will be provided in this field by SSI. The project further leverages a collab-oration with the CellX initiative housed at MOMA, which is a national initiative providing expertise and infrastructure for single-cell omics. Overall, the investigators vouch for both the required number of pa-tients, and a solid and extensive experience with all test methods, equipment, and the necessary infrastructure.
The regulatory requirements for Study 1 and 2 are in place and patient enrollment as well as microbiome sample collection has already begun.
Ethics: None of the smell or taste tests, nor sampling of microbiome and immune factors causes danger, discomfort or pain. GDPR is complied with in all studies and data is stored on computers following legal requirements. The study fulfills the Helsinki declaration and is approved by the local ethic committee (reg.nr. 1-10-72-213-21). Regarding nasal biopsies, this is routine work up in ENT outpatient clinics. The biopsy is taken from middle turbinate in local anesthesia and measures 3x3x3 mm. An additional application for permission to obtain the biopsies will be send to the local ethical committee. The risk of bleeding is very low as patients with hematological diseases and patients in anticoagulant therapy are excluded.
The microbiome will be evaluated using swabs from the nasal cavity and analysed using next-generation sequencing targeting 16S and 18S ribosomal RNA at the Department of Bacteria, Parasite \& Fungi at Staten Serum Institute, Copenhagen, Denmark.
Nasal biopsies (3x3x3 mm) will be characterized histologically and analysed using spatial tran-scriptomics on the Vision 10X Genomics platform. Nasal secretion is collected by means of six swabs and used to characterize the cytokine profile.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's planned enrollment of 619 is above the median of 268 across 3,208 observational studies indexed under COVID-19.
Browse COVID-19 studies →University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.
Compared within COVID-19, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Disease. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Recruitment: population 1, 5, and 6 are recruited among patients undergoing surgery at the ENT department, Regional Hospital West Jutland, Denmark. Populations 2 and 4 are enrolled from the Flavour Clinic, ENT department, Regional Hospital Denmark. Population 3 is recruited at the COVID-19 clinics in Aarhus and Herning. Population 1 will be supplied with staff members and university students.
Inclusion Criteria:
Exclusion Criteria:
Normal sense of smell and absence of sino-nasal disease, upper airway allergies, and no intranasal medication
with olfactory dysfunction
In the acute phase
with olfactory dysfunction persisting for more than 12 weeks
initiating intranasal glucocorticoids
initiating biological treatment with either dupilumab or mepolizumab
This study also gives Dupilumab. No intervention listed here names it: that was found by reading the record.
Microbiome difference
Difference in microbiome between the defined groups
Time frame: 6 months
Effect of nasal glucocorticoids on nasal microbiome
Time frame: 6 months
Correlation between TDI score and nasal microbiome
Time frame: 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Dec 2020 (actual). Primary completion is estimated for Sep 2026, 69 months after the start.
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