COVID-Q: validation of the first COVID-19 questionnaire based on patient-rated symptom gravity (preprint)

Objectives The aim of the present study was to develop and validate the CoronaVirus Disease 2019 (COVID19) Questionnaire (COVIDQ), a novel symptom questionnaire specific for COVID19 patients, to provide a comprehensive evaluation which may be helpful for physicians. A secondary goal of the present study was to evaluate the performance of the COVIDQ in identifying subjects at higher risk of being tested positive for COVID19. Material and methods Consecutive not hospitalized adults who underwent nasopharyngeal and throat swab for severe acute respiratory syndrome coronavirus 2 (SARSCoV2) detection at Treviso Hospital in March 2020, were enrolled. Subjects were divided into positive (cases) and negative (controls) in equal number. All of them gave consent and answered the COVIDQ. Patients not able to answer the COVIDQ due to clinical conditions were excluded. Parallel Analysis and Principal Component Analysis were used to identify clusters of items measuring the same dimension. The Item Response Theory (IRT) based analyses evaluated the functioning of item categories, the presence of clusters of local dependence among items, item fit within the model and model fit to the data. Results Answers obtained from 230 COVID19 cases (113 males, and 117 females; mean age 55 years, range 20 to 99 years) and 230 controls (61 males, and 169 females; mean age 46 years, range 21 to 89) were analyzed. Parallel analysis led to the extraction of six components, which corresponded to as many clinical presentation patterns: asthenia, influenza symptoms, ear and nose symptoms, breathing issues, throat symptoms, and anosmia/ageusia. The final IRT models retained 27 items as significant for symptom assessment. The total score on the questionnaire was significantly associated with positivity to the molecular SARSCoV2 test: subjects with multiple symptoms were significantly more likely to be affected by COVID19 (p < .001). Older age and male gender also represented risk factors. Presence of breathing issues and anosmia/ageusia were significantly related to positivity to SARSCoV2 (p < 0.001). None of the examined comorbidities had a significant association with COVID19 diagnosis. Conclusion According to the analyses, COVIDQ could be validated since the aspects it evaluated were overall significantly related to SARSCoV2 infection. The application of the novel COVIDQ to everyday clinical practice may help identifying subjects who are likely to be affected by COVID19 and address them to a nasopharyngeal swab in order to achieve an early diagnosis.

A pilot feasibility study on SARS-CoV-2 detection method based on nasopharyngeal lavage fluid (preprint)

Objective. Nose and nasopharyngeal swab is the preferred and worldwide accepted method to detect the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) within the nose and nasopharynx. This method may be linked with possible difficulties, such as patient discomfort or complications. This paper shows a pilot study of SARS-CoV-2 detection with nasal and nasopharyngeal lavage fluids. Methods. Nasal lavage fluid was collected from patients who were submitted to SARS-CoV-2 screening test, due to a preceding positive rapid antigen test. A control group was enrolled among healthcare professionals whose nasopharyngeal swab tested negative. Nasal lavages were performed using isotonic saline solution injected through a nasal fossa. Both lavage fluid and traditional nasopharyngeal swab were analyzed by real time PCR and antigenic test. Results. A total of 49 positive subjects were enrolled in the study. Results of the analysis on lavages and nasopharyngeal swabs were concordant for 48 cases, regardless of the antigenic and molecular test performed. Real time PCR resulted weakly positive at swab in one case and negative at lavage fluid. Among the control group (44 subjects) nasopharyngeal swab and lavage fluid analyses returned a negative result. Sensitivity of the molecular test based on nasal lavage fluid, compared to traditional nasal swab, was 97.7%, specificity was 100%, and accuracy was 98.9%, with high agreement (Cohen k, 0.978). Conclusion. Nasal and nasopharyngeal lavages resulted to be highly reliable and well tolerated. A larger series is needed in order to confirm these results. This approach may potentially represent a valid alternative to the traditional swab method in selected cases.

COVID-Q: validation of the first COVID-19 questionnaire based on patient-rated symptom gravity (preprint)

Objectives: The aim of the present study is to develop and validate the COVID-Q, a novel symptom questionnaire specific for COVID-19 patients, to provide a comprehensive and standard clinical evaluation. A secondary goal of the present study was to evaluate the performance of the COVID-Q in identifying subjects at higher risk of being tested positive for COVID-19. Material and methods 460 subjects (230 COVID-19 cases and 230 healthy controls), answered the COVID-Q. Parallel Analysis and Principal Component Analysis were used to identify clusters of items measuring the same dimension. The IRT-based analyses evaluated the functioning of item categories, the presence of clusters of local dependence among items, item fit within the model and model fit to the data. Results Parallel analysis suggested the extraction of six components, which corresponded to as many clinical presentation patterns: asthenia, influenza-like symptoms, ear and nose symptoms, breathing issues, throat symptoms, and anosmia/ageusia. The final IRT models retained 27 items as significant for symptom assessment. The total score on the questionnaire was significantly associated with positivity to the molecular SARS-CoV-2 test. Subjects with multiple symptoms were significantly more likely to be affected by COVID-19 (p < .001). Older age and male gender also represented risk factors. None of the examined comorbidities had a significant association with COVID-19 diagnosis. Conclusion The application of the novel COVID-Q to everyday clinical practice may help identifying subjects who are likely to be affected by COVID-19 and address them to a nasopharyngeal swab in order to achieve an early diagnosis.

High prevalence of long-term psychophysical olfactory dysfunction in patients with COVID-19 (preprint)

This study prospectively assessed the long-term prevalence of self-reported and psychophysically measured olfactory dysfunction in subjects with mild-to-moderate COVID-19. Self-reported smell or taste impairment was prospectively evaluated by SNOT-22 at diagnosis, 4-week, 8-week, and 6-month. At 6 months from the diagnosis, psychophysical evaluation of olfactory function was also performed using the 34-item culturally adapted University of Pennsylvania Smell Identification Test (CA-UPSIT). 145 completed both the 6-month subjective and psychophysical olfactory evaluation. According to CA-UPSIT, 87 subjects (60.0%) exhibited some smell dysfunction, with 54 (37.2) being mildly microsmic, 16 (11.0%) moderately microsmic, 7 (4.8%) severely microsmic, and 10 patients (6.9%) being anosmic. At the time CA-UPSIT was administered, a weak correlation was observed between the self-reported alteration of sense of smell or taste and olfactory test scores (Spearmans r=-0.26). Among 112 patients who self-reported normal sense of smell at last follow-up, CA-UPSIT revealed normal smell in 46 (41.1%), mild microsmia in 46 (41.1%), moderate microsmia in 11 (9.8%), severe microsmia in 3 (2.3%), and anosmia in 6 (5.4%) patients; however, of those patients self-reporting normal smell but who were found to have hypofunction on testing, 62 out of 66 had self-reported reduction in sense of smell or taste at an earlier time point. Despite most patients report a subjectively normal sense of smell, we observed a high percentage of persistent smell dysfunction at 6 months from the diagnosis of SARS-CoV-2 infection, with 11.7% of patients being anosmic or severely microsmic. These data highlight a significant long-term rate of smell alteration in patients with previous SARS-CoV-2 infection.

New onset of loss of smell or taste in household contacts of home-isolated SARS-CoV-2 positive subjects (preprint)

Purpose To estimate the prevalence of smell or taste impairment in household contacts of mildly symptomatic home-isolated SARS-CoV-2 positive patients.Methods Cross sectional study based on ad hoc questions.Results Of 214 mildly symptomatic COVID-19 patients managed at home under self-isolation, 179 reported to have at least one household contact, with the total number of no study participants contacts being 296. Among 175 household contacts not tested for SARS-CoV-2 infection, 67 (38.3%) had SARS-CoV-2 compatible symptoms, 39 (22.3%) had loss of smell or taste with 7 (4.0%) having loss of smell or taste in the absence of other symptoms. The prevalence of smell or taste impairment was 1.5% in patients tested negative compared to 63.0% of those tested positive for SARS-CoV-2 (p<0.001).Conclusion Smell or taste impairment are quite common in not-tested household contacts of mildly symptomatic home-isolated SARS-CoV-2 positive patients. This should be taken into account when estimating the burden of loss of sense of smell and taste during COVID-19 pandemic, and further highlights the value of loss of sense of smell and taste as a marker of infection.