pulmicort and Pneumonia--Viral

To assess the efficacy of local intranasal treatment with budesonide (nasal irrigation), in addition to olfactory rehabilitation, in the management of loss of smell in COVID-19 patients without signs of severity and with persistent hyposmia 30 days after the onset of symptoms. To search for an association between the presence of an obstruction on MRI and the severity of olfactory loss, at inclusion and after 30 days of treatment.. Two center, open-label, 2-arm (1:1 ratio) parallel group randomized controlled superiority trial.. Inclusion criteria - Patient over 18 years of age; - Patient with a suspected SARS-CoV-2 infection, whether or not confirmed by PCR, or close contact with a PCR-confirmed case, typical chest CT scan (unsystematic frosted glass patches with predominantly sub-pleural appearance, and at a later stage, alveolar condensation without excavation or nodules or masses) or positive serology ; - Patient with isolated sudden onset hyposmia persisting 30 days after the onset of symptoms of CoV-2 SARS infection; - Affiliate or beneficiary of a social security scheme; - Written consent to participate in the study. Non-inclusion criteria - Known hypersensitivity to budesonide or any of the excipients; - Hemostasis disorder or epistaxis; - Oral-nasal and ophthalmic herpes virus infection; - Long-term corticosteroid treatment; - Treatment with potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, nefazodone and HIV protease inhibitors); - Severe forms of SARS-CoV-2 with respiratory or other signs; - Hyposmia persisting for more than 90 days after the onset of symptoms - Other causes of hyposmia found on interrogation or MRI; - Patient benefiting from a legal protection measure; - Pregnant or breastfeeding women. The participants will be recruited from: Hôpital Fondation Adolphe de Rothschild and Hôpital Lariboisière in Paris, France INTERVENTION AND COMPARATOR: Intervention: Experimental group: Nasal irrigation with budesonide and physiological saline (Budesonide 1mg/2mL diluted in 250mL of physiological saline 9°/00): 3 syringes of 20mL in each nasal cavity, morning and evening, for 30 days, in addition to olfactory rehabilitation twice a day.. Nasal irrigation with physiological saline 9°/00 only: 3 syringes of 20cc in each nasal cavity, morning and evening, for 30 days, in addition to olfactory rehabilitation twice a day.. Percentage of patients with an improvement of more than 2 points on the ODORATEST score after 30 days of treatment.. Patients will be randomized (1:1) between the experimental and control groups, using the e-CRF. The randomization list will be stratified by centre.. Participants and caregivers are aware of the group assignment. People assessing the outcomes are blinded to the group assignment Numbers to be randomised (sample size) 120 patients are planned to be randomized into two groups of 60 patients.. MDL_2020_10. Version number 2, May 22, 2020. Recruitment started on May 22, 2020. The trial will finish recruiting by August 2020.. EUDRACT number: 2020-001667-85; date of trial registration: 15 May 2020 Protocol registered on ClinicalTrial.gov, registration number: NCT04361474 ; date of trial registration: 24 April 2020.. The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Topics: Betacoronavirus; Budesonide; Coronavirus Infections; COVID-19; Humans; Olfaction Disorders; Pandemics; Pneumonia, Viral; Randomized Controlled Trials as Topic; SARS-CoV-2

Topics: Acetates; Adrenergic beta-2 Receptor Antagonists; Amoxicillin-Potassium Clavulanate Combination; Anti-Asthmatic Agents; Antibodies, Monoclonal, Humanized; Asthma; Azithromycin; Betacoronavirus; Budesonide; Convalescence; Coronavirus Infections; COVID-19; Cyclopropanes; Eosinophils; Female; Humans; Hydroxychloroquine; Ipratropium; Male; Middle Aged; Pandemics; Pneumonia, Viral; Quinolines; SARS-CoV-2; Sulfides; Treatment Outcome

Topics: Adult; Aged; Anti-Inflammatory Agents; Betacoronavirus; Budesonide; Chronic Disease; Coronavirus Infections; COVID-19; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Lavage; Pandemics; Pilot Projects; Pneumonia, Viral; Pregnanes; Retrospective Studies; Rhinitis; SARS-CoV-2; Sinusitis; Treatment Outcome

Topics: Albumins; Betacoronavirus; Budesonide; Clinical Laboratory Techniques; Convalescence; Coronavirus Infections; COVID-19; COVID-19 Drug Treatment; COVID-19 Testing; Female; Fluorine Radioisotopes; Fluorodeoxyglucose F18; Humans; Hydroxychloroquine; Interferons; Middle Aged; Nasopharynx; Pandemics; Pneumonia, Viral; Positron Emission Tomography Computed Tomography; Radiopharmaceuticals; SARS-CoV-2

During the last few years a number of previously undescribed viruses, including human metapneumovirus, coronaviruses SARS, NL63 and HKU1, and bocavirus, were identified in nasopharyngeal samples from patients with signs of respiratory infections. These viruses may cause mild to life-threatening infections.. Nasopharyngeal samples from hospitalized pediatric patients with respiratory disease were analysed for the presence of coronaviruses and other well known and newly identified respiratory viruses.. Two clinical cases of a severe obstructive pneumonia, which were associated with the presence of RNA of a novel variant (subtype) of HKU1 coronavirus in the nasopharyngeal aspirates, were identified.. The detection of a HKU1-like coronavirus in pediatric patients in the current study complement the most recent independent finding of similar or closely related coronaviruses in patients with respiratory diseases in France (Vabret et al. 2006) and Norway (Jonassen et al., see accompanying manuscript). These observations indicate a wide dissemination of HKU1-like coronaviruses in Europe.

Topics: Administration, Inhalation; Adrenal Cortex Hormones; Adrenergic beta-Agonists; Anti-Bacterial Agents; Bronchodilator Agents; Budesonide; Coronavirus; Coronavirus Infections; Hospitalization; Humans; Infant; Infusions, Intravenous; Ipratropium; Length of Stay; Male; Nasopharynx; Oxygen; Phylogeny; Pneumonia, Viral; Reagent Kits, Diagnostic; Reverse Transcriptase Polymerase Chain Reaction; RNA, Viral; Severity of Illness Index; Steroids; Treatment Outcome