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1.
Psychiatry Res ; 316: 114728, 2022 10.
Article in English | MEDLINE | ID: covidwho-1955792

ABSTRACT

INTRODUCTION: With the start of the COVID-19 pandemic, the various social distancing policies imposed have mandated psychiatrists to consider the option of using telepsychiatry as an alternative to face-to-face interview in Hong Kong. Limitations over sample size, methodology and information technology were found in previous studies and the reliability of symptoms assessment remained a concern. AIM: To evaluate the reliability of assessment of psychiatric symptoms by telepsychiatry comparing with face-to-face psychiatric interview. METHOD: This study recruited a sample of adult psychiatric patients in psychiatric wards in Queen Mary Hospital. Semi-structural interviews with the use of standardized psychiatric assessment scales were carried out in telepsychiatry and face-to-face interview respectively by two clinicians and the reliability of psychiatric symptoms elicited were assessed. RESULTS: 90 patients completed the assessments The inter-method reliability in Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale, Columbia Suicide Severity Rating Scale and Brief Psychiatric Rating Scale showed good agreement when compared with face-to-face interview. CONCLUSION: Symptoms assessment by telepsychiatry is comparable to assessment conducted by face-to-face interview.


Subject(s)
COVID-19 , Psychiatry , Telemedicine , Adult , Humans , Pandemics , Psychiatric Status Rating Scales , Psychiatry/methods , Reproducibility of Results , Symptom Assessment
2.
Infect Control Hosp Epidemiol ; 41(7): 820-825, 2020 Jul.
Article in English | MEDLINE | ID: covidwho-2096308

ABSTRACT

OBJECTIVES: Patients with COVID-19 may present with respiratory syndromes indistinguishable from those caused by common viruses. Early isolation and containment is challenging. Although screening all patients with respiratory symptoms for COVID-19 has been recommended, the practicality of such an effort has yet to be assessed. METHODS: Over a 6-week period during a SARS-CoV-2 outbreak, our institution introduced a "respiratory surveillance ward" (RSW) to segregate all patients with respiratory symptoms in designated areas, where appropriate personal protective equipment (PPE) could be utilized until SARS-CoV-2 testing was done. Patients could be transferred when SARS-CoV-2 tests were negative on 2 consecutive occasions, 24 hours apart. RESULTS: Over the study period, 1,178 patients were admitted to the RSWs. The mean length-of-stay (LOS) was 1.89 days (SD, 1.23). Among confirmed cases of pneumonia admitted to the RSW, 5 of 310 patients (1.61%) tested positive for SARS-CoV-2. This finding was comparable to the pickup rate from our isolation ward. In total, 126 HCWs were potentially exposed to these cases; however, only 3 (2.38%) required quarantine because most used appropriate PPE. In addition, 13 inpatients overlapped with the index cases during their stay in the RSW; of these 13 exposed inpatients, 1 patient subsequently developed COVID-19 after exposure. No patient-HCW transmission was detected despite intensive surveillance. CONCLUSIONS: Our institution successfully utilized the strategy of an RSW over a 6-week period to contain a cluster of COVID-19 cases and to prevent patient-HCW transmission. However, this method was resource-intensive in terms of testing and bed capacity.


Subject(s)
Coronavirus Infections/transmission , Cross Infection/transmission , Infection Control/methods , Infectious Disease Transmission, Patient-to-Professional/prevention & control , Occupational Diseases/prevention & control , Patient Isolation , Pneumonia, Viral/transmission , Population Surveillance/methods , Adult , Aged , Aged, 80 and over , Betacoronavirus , COVID-19 , Coronavirus Infections/diagnosis , Coronavirus Infections/prevention & control , Cross Infection/diagnosis , Cross Infection/prevention & control , Early Diagnosis , Female , Humans , Length of Stay , Male , Middle Aged , Pandemics/prevention & control , Patients' Rooms/organization & administration , Personal Protective Equipment , Pneumonia/virology , Pneumonia, Viral/diagnosis , Pneumonia, Viral/prevention & control , SARS-CoV-2 , Singapore , Symptom Assessment , Tertiary Care Centers
3.
JAMA Netw Open ; 5(10): e2238867, 2022 Oct 03.
Article in English | MEDLINE | ID: covidwho-2084947

ABSTRACT

This cohort study of US adults with untreated COVID-19 examines the types and length of symptoms experienced following symptom recurrence.


Subject(s)
COVID-19 , Humans , Symptom Assessment , Recurrence
4.
Ital J Pediatr ; 47(1): 177, 2021 Aug 26.
Article in English | MEDLINE | ID: covidwho-2053937

ABSTRACT

To date, information on COVID-19 long-term post-recovery sequelae in children and adolescents remains scarce. A retrospective descriptive cohort study was performed by collecting data on 92 patients (age ≤ 18 years). All were evaluated during a face-to-face visit following a specially designed post-COVID-19 symptom assessment protocol at the following stage: 1-3 months after COVID-19 onset. Among the 92 children, 45 (49%) were completely free of any COVID-19-related symptoms, while 47 (51%) reported persistence of at least one symptom, in particular tiredness, loss of taste and/or smell and headaches. The most common post-acute COVID-19 clinical features were noted in children aged between 10 and 18 years. A detailed multidisciplinary follow-up of patients with COVID-19 seems relevant, whatever the severity of the symptoms.


Subject(s)
COVID-19/complications , COVID-19/epidemiology , Adolescent , Age Factors , COVID-19/diagnosis , Child , Child, Preschool , Female , Humans , Infant , Male , Retrospective Studies , Symptom Assessment , Time Factors
5.
Neurosci Biobehav Rev ; 142: 104902, 2022 11.
Article in English | MEDLINE | ID: covidwho-2049711

ABSTRACT

Coronavirus 2 is responsible for Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2), and the main sequela is persistent fatigue. Post-viral fatigue is common and affects patients with mild, asymptomatic coronavirus disease-2019 (COVID-19). However, the exact mechanisms involved in developing post-COVID-19 fatigue remain unclear. Furthermore, physical and cognitive impairments in these individuals have been widely described. Therefore, this review aims to summarize and propose tools from a multifaceted perspective to assess COVID-19 infection. Herein, we point out the instruments that can be used to assess fatigue in long-term COVID-19: fatigue in a subjective manner or fatigability in an objective manner. For physical and mental fatigue, structured questionnaires were used to assess perceived symptoms, and physical and cognitive performance assessment tests were used to measure fatigability using reduced performance.


Subject(s)
COVID-19 , Fatigue , Humans , Cognition , COVID-19/complications , COVID-19/diagnosis , Fatigue Syndrome, Chronic/diagnosis , Fatigue Syndrome, Chronic/etiology , Fatigue Syndrome, Chronic/physiopathology , SARS-CoV-2 , Symptom Assessment , Fatigue/diagnosis , Fatigue/etiology , Fatigue/physiopathology , Mental Fatigue/diagnosis , Mental Fatigue/etiology , Mental Fatigue/physiopathology , Surveys and Questionnaires , Neuropsychological Tests
9.
JAMA Otolaryngol Head Neck Surg ; 148(4): 333-341, 2022 04 01.
Article in English | MEDLINE | ID: covidwho-1955879

ABSTRACT

IMPORTANCE: Patients with head and neck cancer manage a variety of symptoms at home on an outpatient basis. Clinician review alone often leaves patient symptoms undetected and untreated. Standardized symptom assessment using patient-reported outcomes (PROs) has been shown in randomized clinical trials to improve symptom detection and overall survival, although translation into real-world settings remains a challenge. OBJECTIVE: To better understand how patients with head and neck cancer cope with cancer-related symptoms and to examine their perspectives on standardized symptom assessment. DESIGN, PARTICIPANTS, AND SETTING: This was a qualitative analysis using semistructured interviews of patients with head and neck cancer and their caregivers from November 2, 2020, to April 16, 2021, at a regional tertiary center in Canada. Purposive sampling was used to recruit a varied group of participants (cancer subsite, treatment received, sociodemographic factors). Drawing on the Supportive Care Framework, a thematic approach was used to analyze the data. Data analysis was performed from November 2, 2020, to August 2, 2021. MAIN OUTCOMES AND MEASURES: Patient perception of ambulatory symptom management and standardized symptom assessment. RESULTS: Among 20 participants (median [range] age, 59.5 [33-74] years; 9 [45%] female; 13 [65%] White individuals), 4 themes were identified: (1) timely physical symptom management, (2) information as a tool for symptom management, (3) barriers to psychosocial support, and (4) external factors magnifying symptom burden. Participants' perceptions of standardized symptom assessment varied. Some individuals described the symptom monitoring process as facilitating self-reflection and symptom detection. Others felt disempowered by the process, particularly when symptom scores were inconsistently reviewed or acted on. CONCLUSIONS AND RELEVANCE: This qualitative analysis provides a novel description of head and neck cancer symptom management from the patient perspective. The 4 identified themes and accompanying recommendations serve as guides for enhanced symptom monitoring.


Subject(s)
Head and Neck Neoplasms , Outpatients , Adult , Aged , Female , Head and Neck Neoplasms/diagnosis , Head and Neck Neoplasms/therapy , Humans , Male , Middle Aged , Palliative Care , Patient Reported Outcome Measures , Symptom Assessment
10.
Circulation ; 144(6): e123-e135, 2021 08 10.
Article in English | MEDLINE | ID: covidwho-1883361

ABSTRACT

Myocarditis remains a clinical challenge in pediatrics. Originally, it was recognized at autopsy before the application of endomyocardial biopsy, which led to a histopathology-based diagnosis such as in the Dallas criteria. Given the invasive and low-sensitivity nature of endomyocardial biopsy, its diagnostic focus shifted to a reliance on clinical suspicion. With the advances of cardiac magnetic resonance, an examination of the whole heart in vivo has gained acceptance in the pursuit of a diagnosis of myocarditis. The presentation may vary from minimal symptoms to heart failure, life-threatening arrhythmias, or cardiogenic shock. Outcomes span full resolution to chronic heart failure and the need for heart transplantation with inadequate clues to predict the disease trajectory. The American Heart Association commissioned this writing group to explore the current knowledge and management within the field of pediatric myocarditis. This statement highlights advances in our understanding of the immunopathogenesis, new and shifting dominant pathogeneses, modern laboratory testing, and use of mechanical circulatory support, with a special emphasis on innovations in cardiac magnetic resonance imaging. Despite these strides forward, we struggle without a universally accepted definition of myocarditis, which impedes progress in disease-targeted therapy.


Subject(s)
Myocarditis/diagnosis , Myocarditis/therapy , Animals , Biopsy , Child , Clinical Decision-Making , Combined Modality Therapy , Disease Management , Disease Models, Animal , Disease Susceptibility/immunology , Humans , Multimodal Imaging , Myocarditis/etiology , Myocarditis/mortality , Prognosis , Symptom Assessment , Treatment Outcome
11.
Support Care Cancer ; 30(9): 7535-7544, 2022 Sep.
Article in English | MEDLINE | ID: covidwho-1877841

ABSTRACT

Prior to the COVID-19 pandemic, patients attending ambulatory clinics at cancer centers in Ontario completed the Edmonton Symptom Assessment Scale (ESAS) at each visit. At our center, completion was via touchpad, with assistance from clinic volunteers. As of March 2020, clinic appointments were conducted virtually when possible and touch pads removed. We anticipated a negative impact on the collection of patient-reported outcomes (PROs) and the recognition of severe symptoms. METHODS: We performed a prospective cross-sectional cohort study to investigate remote ESAS completion by patients with appointments at a weekly surgical oncology clinic. Patients in the initial study cohort were asked to complete and return the ESAS virtually (V). Given low completion rates, the ensuing cohort was asked to complete a hard-copy (HC) ESAS. For the final cohort, we provided remote, personal mentorship by a member of the care team to support virtual electronic ESAS completion (virtual-mentored (VM) cohort). RESULTS: Between May and July 2020, a total of 174 patient encounters were included in the study. For the V cohort, 20/46 patients (44%) successfully completed and returned the electronic ESAS, compared to 49/50 (98%) for the HC cohort. For the VM cohort, the overall completion rate was 74% (58/78); however, 12 of these 58 patients did not independently complete a virtual ESAS. Virtual questionnaire completion was not predicted by age, sex, or tumor site, although patients who completed the ESAS were more likely to be in active management rather than surveillance (p = 0.04). Of all completed forms, 42% revealed a depression score of ≥2, and 27% an anxiety score of ≥4. CONCLUSIONS: We identified significant barriers to the virtual completion of ESAS forms, with a lack of predictive variables. The severe degree of psychological distress reported by ~50% of respondents demonstrates the need for ongoing regular collection/review of these data. Innovative solutions are required to overcome barriers to the virtual collection of PROs.


Subject(s)
COVID-19 , Neoplasms , Cross-Sectional Studies , Humans , Neoplasms/psychology , Pandemics , Patient Reported Outcome Measures , Prospective Studies , Symptom Assessment
12.
Clin Otolaryngol ; 47(5): 561-567, 2022 09.
Article in English | MEDLINE | ID: covidwho-1874404

ABSTRACT

OBJECTIVES: To report the incidence of locoregional recurrence in head and neck cancer (HNC) patients under surveillance following treatment undergoing symptom-based remote assessment. DESIGN: A 16-week multicentre prospective cohort study. SETTING: UK ENT departments. PARTICIPANTS: HNC patients under surveillance following treatment undergoing symptom-based telephone assessment. MAIN OUTCOME MEASURES: Incidence of locoregional recurrent HNC after minimum 6-month follow-up. RESULTS: Data for 1078 cases were submitted by 16 centres, with follow-up data completed in 98.9% (n = 1066). Following telephone consultation, 83.7% of referrals had their face-to-face appointments deferred (n = 897/1072). New symptoms were reported by 11.6% (n = 124/1072) at telephone assessment; 72.6% (n = 90/124) of this group were called for urgent assessments, of whom 48.9% (n = 44/90) came directly for imaging without preceding clinical review. The sensitivity and specificity for new symptoms as an indicator of cancer recurrence were 35.3% and 89.4%, respectively, with a negative predictive value of 99.7% (p = .002). Locoregional cancer identification rates after a minimum of 6 months of further monitoring, when correlated with time since treatment, were 6.0% (n = 14/233) <1 year; 2.1% (n = 16/747) between 1 and 5 years; and 4.3% (n = 4/92) for those >5 years since treatment. CONCLUSIONS: Telephone assessment, using patient-reported symptoms, to identify recurrent locoregional HNC was widely adopted during the initial peak of the COVID-19 pandemic in the United Kingdom. The majority of patients had no face-to-face reviews or investigations. New symptoms were significantly associated with the identification of locoregional recurrent cancers with a high specificity, but a low sensitivity may limit symptom assessment being used as the sole surveillance method.


Subject(s)
COVID-19 , Head and Neck Neoplasms , COVID-19/epidemiology , Head and Neck Neoplasms/diagnosis , Head and Neck Neoplasms/epidemiology , Head and Neck Neoplasms/therapy , Humans , Neoplasm Recurrence, Local/diagnosis , Neoplasm Recurrence, Local/epidemiology , Neoplasm Recurrence, Local/therapy , Pandemics , Prospective Studies , Referral and Consultation , Symptom Assessment , Telephone
13.
BMC Pregnancy Childbirth ; 21(1): 658, 2021 Sep 28.
Article in English | MEDLINE | ID: covidwho-1770502

ABSTRACT

BACKGROUND: Whilst the impact of Covid-19 infection in pregnant women has been examined, there is a scarcity of data on pregnant women in the Middle East. Thus, the aim of this study was to examine the impact of Covid-19 infection on pregnant women in the United Arab Emirates population. METHODS: A case-control study was carried out to compare the clinical course and outcome of pregnancy in 79 pregnant women with Covid-19 and 85 non-pregnant women with Covid-19 admitted to Latifa Hospital in Dubai between March and June 2020. RESULTS: Although Pregnant women presented with fewer symptoms such as fever, cough, sore throat, and shortness of breath compared to non-pregnant women; yet they ran a much more severe course of illness. On admission, 12/79 (15.2%) Vs 2/85 (2.4%) had a chest radiograph score [on a scale 1-6] of ≥3 (p-value = 0.0039). On discharge, 6/79 (7.6%) Vs 1/85 (1.2%) had a score ≥3 (p-value = 0.0438). They also had much higher levels of laboratory indicators of severity with values above reference ranges for C-Reactive Protein [(28 (38.3%) Vs 13 (17.6%)] with p < 0.004; and for D-dimer [32 (50.8%) Vs 3(6%)]; with p < 0.001. They required more ICU admissions: 10/79 (12.6%) Vs 1/85 (1.2%) with p=0.0036; and suffered more complications: 9/79 (11.4%) Vs 1/85 (1.2%) with p=0.0066; of Covid-19 infection, particularly in late pregnancy. CONCLUSIONS: Pregnant women presented with fewer Covid-19 symptoms but ran a much more severe course of illness compared to non-pregnant women with the disease. They had worse chest radiograph scores and much higher levels of laboratory indicators of disease severity. They had more ICU admissions and suffered more complications of Covid-19 infection, such as risk for miscarriage and preterm deliveries. Pregnancy with Covid-19 infection, could, therefore, be categorised as high-risk pregnancy and requires management by an obstetric and medical multidisciplinary team.


Subject(s)
COVID-19 , Intensive Care Units/statistics & numerical data , Pregnancy Complications, Infectious , Premature Birth , Radiography, Thoracic , Symptom Assessment , Abortion, Spontaneous/epidemiology , Abortion, Spontaneous/etiology , C-Reactive Protein/analysis , COVID-19/blood , COVID-19/epidemiology , COVID-19/therapy , COVID-19/transmission , Case-Control Studies , Female , Fibrin Fibrinogen Degradation Products/analysis , Humans , Infant, Newborn , Infectious Disease Transmission, Vertical/prevention & control , Male , Pregnancy , Pregnancy Complications, Infectious/epidemiology , Pregnancy Complications, Infectious/physiopathology , Pregnancy Complications, Infectious/therapy , Pregnancy Complications, Infectious/virology , Pregnancy Outcome/epidemiology , Pregnancy, High-Risk , Premature Birth/epidemiology , Premature Birth/etiology , Radiography, Thoracic/methods , Radiography, Thoracic/statistics & numerical data , SARS-CoV-2/isolation & purification , Severity of Illness Index , Symptom Assessment/methods , Symptom Assessment/statistics & numerical data , United Arab Emirates/epidemiology
15.
J Am Coll Cardiol ; 79(4): 311-323, 2022 02 01.
Article in English | MEDLINE | ID: covidwho-1708070

ABSTRACT

BACKGROUND: Recently, the number of patients presenting with non-ST-segment elevation myocardial infarction (NSTEMI) has reduced, whereas increased mortality was reported. A plausible explanation for increased mortality was prehospital delay because of patients' reticence of their symptoms. OBJECTIVES: The purpose of this study was to investigate the association between prehospital delay and clinical outcomes in patients with NSTEMI METHODS: Among 13,104 patients from the Korea-Acute-Myocardial-Infarction-Registry-National Institutes of Health, the authors evaluated 6,544 patients with NSTEMI. Study patients were categorized into 2 groups according to symptom-to-door (StD) time (<24 or ≥24 hours). The primary outcome was 3-year all-cause mortality, and the secondary outcome was 3-year composite of all-cause mortality, recurrent MI, and hospitalization for heart failure. RESULTS: Overall, 1,827 (27.9%) patients were classified into the StD time ≥24 hours group. The StD time ≥24 hours group had higher all-cause mortality (17.0% vs 10.5%; P < 0.001) and incidence of secondary outcomes (23.3% vs 15.7%; P < 0.001) than the StD time <24 hours group. The higher all-cause mortality in the StD time ≥24 hours group was observed consistently in the subgroup analysis regarding age, sex, atypical chest pain, dyspnea, Q-wave in electrocardiogram, use of emergency medical services, hypertension, diabetes mellitus, chronic kidney disease, left ventricle dysfunction, TIMI (Thrombolysis In Myocardial Infarction) flow, and the GRACE risk score. In the multivariable analysis, independent predictors of prehospital delay were the elderly, women, nonspecific symptoms such as atypical chest pain or dyspnea, diabetes, and no use of emergency medical services. CONCLUSIONS: Prehospital delay is associated with an increased risk of 3-year all-cause mortality in patients with NSTEMI. (iCReaT Study No. C110016).


Subject(s)
Hospitalization , Non-ST Elevated Myocardial Infarction/mortality , Non-ST Elevated Myocardial Infarction/therapy , Time-to-Treatment , Aged , Emergency Medical Services , Female , Humans , Male , Middle Aged , Myocardial Revascularization , Non-ST Elevated Myocardial Infarction/complications , Registries , Republic of Korea , Risk Factors , Survival Rate , Symptom Assessment
16.
J Emerg Med ; 62(6): 716-724, 2022 06.
Article in English | MEDLINE | ID: covidwho-1700394

ABSTRACT

BACKGROUND: COVID-19 has been associated with increased risk of thromboembolism in critically ill patients. OBJECTIVE: We sought to examine the association of SARS-CoV-2 test positivity and subsequent acute vascular thrombosis, including venous thromboembolism (VTE) or arterial thrombosis (AT), in a large nationwide registry of emergency department (ED) patients tested with a nucleic acid test for suspected SARS-CoV-2. METHODS: The RECOVER (Registry of Potential COVID-19 in Emergency Care) registry includes 155 EDs across the United States. We performed a retrospective cohort study to produce odds ratios (ORs) for COVID-19-positive vs. COVID-19-negative status as a predictor of 30-day VTE or AT, adjusting for age, sex, active cancer, intubation, hospital length of stay, and intensive care unit (ICU) care. RESULTS: Comparing 14,056 COVID-19-positive patients with 12,995 COVID-19-negative patients, the overall 30-day prevalence of VTE events was 1.4% vs. 1.3%, respectively (p = 0.44, χ2). Multivariable analysis identified that testing positive for SARS-CoV-2 status was negatively associated with both VTE (OR 0.76; 95% confidence interval [CI] 0.61-0.94) and AT (OR 0.51; 95% CI 0.32-0.80), whereas intubation, ICU care, and age 50 years or older were positively associated with both VTE and AT. CONCLUSIONS: In contrast to other reports, results from this large, hetereogenous national sample of ED patients tested for SARS-CoV-2, showed no association between vascular thrombosis and COVID-19 test positivity.


Subject(s)
COVID-19 , Thrombosis , Venous Thromboembolism , Ambulatory Care , COVID-19/diagnosis , COVID-19/epidemiology , Female , Humans , Male , Middle Aged , Retrospective Studies , SARS-CoV-2/isolation & purification , Symptom Assessment , Thrombosis/epidemiology , Venous Thromboembolism/epidemiology
17.
Virology ; 569: 37-43, 2022 04.
Article in English | MEDLINE | ID: covidwho-1692814

ABSTRACT

Risk factors for disease progression and severity of SARS-CoV-2 infections require an understanding of acute and long-term virological and immunological dynamics. Fifty-one RT-PCR positive COVID-19 outpatients were recruited between May and December 2020 in Munich, Germany, and followed up at multiple defined timepoints for up to one year. RT-PCR and viral culture were performed and seroresponses measured. Participants were classified applying the WHO clinical progression scale. Short symptom to test time (median 5.0 days; p = 0.0016) and high viral loads (VL; median maximum VL: 3∙108 copies/mL; p = 0.0015) were indicative for viral culture positivity. Participants with WHO grade 3 at baseline had significantly higher VLs compared to those with WHO 1 and 2 (p = 0.01). VLs dropped fast within 1 week of symptom onset. Maximum VLs were positively correlated with the magnitude of Ro-N-Ig seroresponse (p = 0.022). Our results describe the dynamics of VLs and antibodies to SARS-CoV-2 in mild to moderate cases that can support public health measures during the ongoing global pandemic.


Subject(s)
COVID-19/diagnosis , COVID-19/virology , SARS-CoV-2/physiology , Viral Load , Adolescent , Adult , COVID-19/complications , Child , Cohort Studies , Host-Pathogen Interactions , Humans , Longitudinal Studies , Middle Aged , Outpatients , Pandemics , Serologic Tests/methods , Symptom Assessment , Young Adult
18.
JAMA Netw Open ; 5(2): e2144942, 2022 02 01.
Article in English | MEDLINE | ID: covidwho-1676319

ABSTRACT

Importance: Oral anthelmintic niclosamide has potent in vitro antiviral activity against SARS-CoV-2. Repurposed niclosamide could be a safe and efficacious COVID-19 therapy. Objective: To investigate whether niclosamide decreased SARS-CoV-2 shedding and duration of symptoms among patients with mild to moderate COVID-19. Design, Setting, and Participants: This randomized, placebo-controlled clinical trial enrolled individuals testing positive for SARS-CoV-2 by polymerase chain reaction with mild to moderate symptoms of COVID. All trial participants, investigators, staff, and laboratory personnel were kept blind to participant assignments. Enrollment was among individuals reporting at Tufts Medical Center and Wellforce Network in Massachusetts for outpatient COVID-19 testing. The trial opened to accrual on October 1, 2020; the last participant enrolled on April 20, 2021. Trial exclusion criteria included hospitalization at time of enrollment or use of any experimental treatment for COVID-19, including vaccination. Enrollment was stopped before attaining the planned sample size when COVID-19 diagnoses decreased precipitously in Massachusetts. Data were analyzed from July through September 2021. Interventions: In addition to receiving current standard of care, participants were randomly assigned on a 1:1 basis to receive niclosamide 2 g by mouth daily for 7 days or identically labeled placebo at the same dosing schedule. Main Outcomes and Measures: Oropharyngeal and fecal samples were self-collected for viral shedding measured by reverse-transcriptase-polymerase-chain-reaction on days 3, 7, 10, and 14, and an additional fecal sample was collected on day 21. A telehealth platform was developed to conduct remote study visits, monitor symptoms, and coordinate sample collection via couriers. The primary end point was the proportion of participants with viral clearance in respiratory samples at day 3 based on the intention-to-treat sample. Mean times to viral clearance and symptom resolution were calculated as restricted mean survival times and accounted for censored observations. Results: Among 73 participants, 36 individuals were enrolled and randomized to niclosamide and 37 individuals to placebo. Participant characteristics were similar across treatment groups; among 34 patients receiving placebo and 33 patients receiving niclosamide in the intention-to-treat sample, mean (SD) age was 36.0 (13.3) years vs 36.8 (12.9) years and there were 21 (61.8%) men vs 20 (60.6%) men. The overall mean (SD) age was 36.4 (13.0) years. For the primary end point, 66.67% (95% CI, 50.74% to 81.81%) of participants receiving niclosamide and 55.88% (95% CI, 40.27% to 72.73%) of participants receiving placebo had oropharyngeal SARS-CoV-2 clearance at day 3 (P = .37). Among 63 participants with symptoms, niclosamide did not significantly shorten symptom duration, which was 12.01 (95% CI, 8.82 to 15.2) days in the niclosamide group vs 14.61 (95% CI, 11.25 to 17.96) days in the placebo group (mean difference, -2.6 [95% CI, -7.23 to 2.03] days). Niclosamide was well-tolerated; the most commonly reported adverse events in the placebo and niclosamide groups were headaches (11 patients [32.4%] vs 7 patients [21.2%]; P = .31) and cough (8 patients [23.5%] vs 7 patients [21.2%]; P = .82). Conclusions and Relevance: In this randomized clinical trial, there was no significant difference in oropharyngeal clearance of SARS-CoV-2 at day 3 between placebo and niclosamide groups. Confirmation in larger studies is warranted. Trial Registration: ClinicalTrials.gov Identifier: NCT04399356.


Subject(s)
Antiviral Agents/therapeutic use , COVID-19/drug therapy , Drug Repositioning , Niclosamide/therapeutic use , SARS-CoV-2/drug effects , Virus Shedding/drug effects , Adult , Female , Humans , Male , Massachusetts , Middle Aged , Symptom Assessment , Treatment Outcome
19.
Nat Immunol ; 23(2): 194-202, 2022 02.
Article in English | MEDLINE | ID: covidwho-1671599

ABSTRACT

The world continues to contend with successive waves of coronavirus disease 2019 (COVID-19), fueled by the emergence of viral variants. At the same time, persistent, prolonged and often debilitating sequelae are increasingly recognized in convalescent individuals, named 'post-COVID-19 syndrome' or 'long-haul COVID'. Clinical symptomatology includes fatigue, malaise, dyspnea, defects in memory and concentration and a variety of neuropsychiatric syndromes as the major manifestations, and several organ systems can be involved. The underlying pathophysiological mechanisms are poorly understood at present. This Review details organ-specific sequelae of post-COVID-19 syndromes and examines the underlying pathophysiological mechanisms available so far, elaborating on persistent inflammation, induced autoimmunity and putative viral reservoirs. Finally, we propose diagnostic strategies to better understand this heterogeneous disorder that continues to afflict millions of people worldwide.


Subject(s)
COVID-19/complications , SARS-CoV-2/pathogenicity , COVID-19/immunology , COVID-19/physiopathology , COVID-19/virology , Host-Pathogen Interactions , Humans , Prognosis , SARS-CoV-2/immunology , Symptom Assessment , Time Factors
20.
JAMA Netw Open ; 5(2): e2147053, 2022 02 01.
Article in English | MEDLINE | ID: covidwho-1669328

ABSTRACT

Importance: New symptoms and conditions can develop following SARS-CoV-2 infection. Whether they occur more frequently among persons with SARS-CoV-2 infection compared with those without is unclear. Objective: To compare the prevalence of new diagnoses of select symptoms and conditions between 31 and 150 days after testing among persons who tested positive vs negative for SARS-CoV-2. Design, Setting, and Participants: This cohort study analyzed aggregated electronic health record data from 40 health care systems, including 338 024 persons younger than 20 years and 1 790 886 persons aged 20 years or older who were tested for SARS-CoV-2 during March to December 2020 and who had medical encounters between 31 and 150 days after testing. Main Outcomes and Measures: International Statistical Classification of Diseases, Tenth Revision, Clinical Modification codes were used to capture new symptoms and conditions that were recorded 31 to 150 days after a SARS-CoV-2 test but absent in the 18 months to 7 days prior to testing. The prevalence of new symptoms and conditions was compared between persons with positive and negative SARS-CoV-2 tests stratified by age (20 years or older and young than 20 years) and care setting (nonhospitalized, hospitalized, or hospitalized and ventilated). Results: A total of 168 701 persons aged 20 years or older and 26 665 younger than 20 years tested positive for SARS-CoV-2, and 1 622 185 persons aged 20 years or older and 311 359 younger than 20 years tested negative. Shortness of breath was more common among persons with a positive vs negative test result among hospitalized patients (≥20 years: prevalence ratio [PR], 1.89 [99% CI, 1.79-2.01]; <20 years: PR, 1.72 [99% CI, 1.17-2.51]). Shortness of breath was also more common among nonhospitalized patients aged 20 years or older with a positive vs negative test result (PR, 1.09 [99% CI, 1.05-1.13]). Among hospitalized persons aged 20 years or older, the prevalence of new fatigue (PR, 1.35 [99% CI, 1.27-1.44]) and type 2 diabetes (PR, 2.03 [99% CI, 1.87-2.19]) was higher among those with a positive vs a negative test result. Among hospitalized persons younger than 20 years, the prevalence of type 2 diabetes (PR, 2.14 [99% CI, 1.13-4.06]) was higher among those with a positive vs a negative test result; however, the prevalence difference was less than 1%. Conclusions and Relevance: In this cohort study, among persons hospitalized after a positive SARS-CoV-2 test result, diagnoses of certain symptoms and conditions were higher than among those with a negative test result. Health care professionals should be aware of symptoms and conditions that may develop after SARS-CoV-2 infection, particularly among those hospitalized after diagnosis.


Subject(s)
COVID-19/physiopathology , Symptom Assessment/statistics & numerical data , Adolescent , Adult , Age Factors , Aged , Aged, 80 and over , COVID-19/epidemiology , Child , Child, Preschool , Cohort Studies , Female , Humans , Infant , Infant, Newborn , Male , Middle Aged , Prevalence , SARS-CoV-2 , Socioeconomic Factors , Time Factors , Young Adult
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