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2.
Cad Saude Publica ; 37(3): e00182720, 2021.
Article in English | MEDLINE | ID: mdl-33950075

ABSTRACT

This is a cross-sectional study investigating the factors affecting brazilians' self-rated health during the COVID-19 pandemic, based on data from the web-based behavior survey. Carried out from April 24 to May 24, 2020, the survey recruited participants by a chain sampling procedure. Its outcome was the worsening of self-rated health during the pandemic. Statistical analysis was based on a hierarchical model of determination. Logistic regression models were used to test the associations between sociodemographic characteristics, pre-existing health conditions, lifestyle indicators and intensity of social restraint measures, and biological and psychological issues during the pandemic. From the total sample of 45,161 participants, 29.4% reported worsening of health state during this period. After adjusting for hierarchical distal factors, the health problems mostly associated with worsening health state were: bad self-rated health (adjusted OR = 4.35, p < 0.001), health care seeking for mental health problem (adjusted OR = 3.95, p < 0.001), and for COVID-19 (adjusted OR = 3.60, p < 0.001). People who experienced sleep problems, worsening of back pain, depression and at least one flu symptom during the pandemic were twice as likely to report worsening of health status. Sedentary and eating behaviors and adherence to social distancing measures showed significant correlation with the outcome. There exists a relation between social, biological, and psychological factors, mediated by lifestyles and variables pertaining to confinement. Altogether, these factors have negatively affected self-rated health during the COVID-19 pandemic in Brazil.


Subject(s)
Pandemics , Brazil/epidemiology , Cross-Sectional Studies , Humans
3.
Cad Saude Publica ; 37(3): e00218320, 2021.
Article in English, Portuguese | MEDLINE | ID: mdl-33950076

ABSTRACT

Sleep is a fundamental aspect for maintaining physical and emotional health, as well as one's well-being. Few studies have assessed the effect of socioeconomic conditions on sleep in the COVID-19 pandemic. Our objective was to analyze the increase or incidence of sleep disorders according to demographic and economic conditions, prior to the pandemic, and according to changes in financial, occupational, and household conditions during the pandemic. This study was conducted via web access, using data from April 24 to May 24, with 45,160 Brazilians (aged 18 or older), with a sample weighted by Brazilian National Household Sample Survey (PNAD) data. Change in sleep quality (outcome), monthly income, effect on family income, occupation/work, gender, age group, marital status, and change in domestic work (exposures) were reported. The percentages of onset or increase of sleep disorders and adjusted odds ratio were estimated. The chance of exacerbation of sleep disorders was 34%, 71%, and twice as high in people with income less than one minimum wage before the pandemic, in those who lost their job and in those who had a great decrease in their income/were without income, respectively. The chance of worsening sleep disorders was 82% higher in women; three times higher (OR = 3.14) in the population aged from 18 to 29, compared to the older adults; and higher with the increase in the amount of housework (OR = 2.21). Financial and occupational factors were determinants in the worsening of self-reported sleep quality, requiring rapid actions on these conditions in order to minimize this effect. Gender, age group, and household routines also deserve attention regarding sleep quality.


Subject(s)
Sleep Wake Disorders , Adolescent , Aged , Brazil/epidemiology , Female , Humans , Incidence , Pandemics , Sleep Wake Disorders/epidemiology
4.
Cad Saude Publica ; 37(3): e00221920, 2021.
Article in English | MEDLINE | ID: mdl-33950077

ABSTRACT

This study analyzed changes in the prevalence of physical inactivity and sedentary behaviors according to correlates during the COVID-19 pandemic among Brazilian adults. A national retrospective online survey was conducted with 39,693 Brazilian adults. Physical activity (weekly frequency and daily duration; cut-off point of 150 minutes/week), TV-viewing time and computer/tablet use (daily duration; cut-off point of 4 hours/day) before and during the pandemic period were reported. Sex, age group, schooling level, skin color, per capita income, country region, working status during the quarantine, and adherence to the quarantine were the correlates. Descriptive statistics were used. The prevalence of physical inactivity, high TV-viewing time and computer/tablet use increased, respectively, 26%, 266%, and 38% during the pandemic. While increases in physical inactivity and computer/tablet were more widespread, higher increases in the prevalence of high TV viewing tiem were observed among younger adults (660%), with higher schooling level (437%) and those who were at home office (331%). The prevalence of physical inactivity and sedentary behaviors increased in all population sub-groups during the COVID-19 pandemic in Brazil.


Subject(s)
Sedentary Behavior , Adult , Brazil/epidemiology , Cross-Sectional Studies , Humans , Pandemics , Prevalence , Retrospective Studies
5.
Cad Saude Publica ; 37(3): e00268320, 2021.
Article in English, Portuguese | MEDLINE | ID: mdl-33950078

ABSTRACT

The ConVid - Behavior Survey was conducted in Brazil from April 24 to May 24, 2020, aiming to investigate changes in lifestyles and health conditions during the COVID-19 pandemic. In this article, we present the conception and methodology of the research. We used a cross-sectional study using an Internet questionnaire, with questions validated in previous health surveys. The sampling method "virtual snowball" was used, as well as post-stratification procedures. The results related to chronic non-communicable diseases and pre-pandemic lifestyles were compared with estimates from the 2013 Brazilian National Health Survey and 2019 Surveillance of Risk and Protective Factors for Chronic Diseases by Telephone Survey. The total sample was 45,161 people. After data weighing, the sample distributions of demographic variables were similar to population variables. Only people with a low schooling level were underrepresented. The comparison with the previous results showed similarity in most estimates: recommended consumption of fruits and vegetables (22.1%), recommended physical activity (35.2%), tobacco smoking habit (12.3%), frequent and abusive alcohol consumption (6.7%), obesity (21.2%), self-reported prevalence of hypertension (18.6%), diabetes (7.1%), and heart disease (4.4%). The online survey made it possible to know the population's health conditions during the pandemic. The similarity of the indicators with those obtained in traditional research allowed the validation of the mean estimates. Studies are needed to investigate how the endogenous effects of virtual social networks can be considered when estimating variance.


Subject(s)
Pandemics , Brazil/epidemiology , Cross-Sectional Studies , Humans , Internet , Surveys and Questionnaires
6.
Dental Press J Orthod ; 26(2): e2119244, 2021.
Article in English | MEDLINE | ID: mdl-33950081

ABSTRACT

OBJECTIVE: To assess the influence of early childhood malocclusion on oral health-related quality of life (OHRQoL). METHODS: 7-year cohort study involving 639 preschoolers (1 to 5 years) who had been evaluated initially with a survey conduced in 2010. Children completed the Brazilian version of the Child Perception Questionnaire (CPQ8-10) to assess OHRQoL during the follow-up period. Exploratory variables were collected at baseline, including the presence and severity of malocclusion (overjet and lip coverage). Socioeconomic characteristics, oral health behavior, and patterns of dental attendance were also investigated. A multilevel Poisson regression model was used to fit the association between malocclusion and OHRQoL. With this approach, incidence rate ratio (IRR) and 95% confidence intervals (95% CI) were calculated. RESULTS: A total of 449 children were re-evaluated (follow-up rate, 70.3%). The prevalence of accentuated overjet and inadequate lip coverage was 13.5% and 11.9%, respectively. The mean (±SD) CPQ8-10 score was 10.57±10.32. The presence of inadequate lip coverage was associated with higher overall mean CPQ8-10 scores (IRR 1.51; 95% CI 1.29-1.77), and social well-being, emotional well-being, and functional limitation domains. Children with accentuated overjet (>3mm) also demonstrated higher overall scores on the CPQ8-10 than their normal counterparts. The presence of this condition also influenced the oral symptom (IRR 1.29; 95% CI 1.08-1.53) and emotional well-being (IRR 1.30; 95% CI 1.02-1.66) domains. CONCLUSION: Results of the present study suggest that early childhood malocclusion is a risk factor for low OHRQoL in future.


Subject(s)
Dental Caries , Malocclusion , Brazil/epidemiology , Child , Child, Preschool , Cohort Studies , Cross-Sectional Studies , Humans , Malocclusion/epidemiology , Oral Health , Quality of Life , Surveys and Questionnaires
7.
Cad Saude Publica ; 37(4): e00304320, 2021.
Article in Portuguese | MEDLINE | ID: mdl-33950089

ABSTRACT

Although children have been identified as the group least affected by COVID-19 symptoms (even though they are not automatically shielded from the disease or its severe forms), their daily lives have been affected in various ways, including interruption of in-person school activities and contact with classmates, besides other impacts from social isolation and in many cases family financial and health problems. This study aims to understand the perceptions of children in Rio de Janeiro, Brazil towards SARS-CoV-2, COVID-19, and viruses in general, through a qualitative study. We interviewed 20 children via conference services platforms. The findings indicate that children are aware of the risks and necessary precautions for coronavirus prevention, displaying apprehension and fear of catching the disease and transmitting it to their family members. As for viruses in general, we found that their perceptions are related directly to the novel coronavirus, that is, the situation they are dealing with at present. The study provides elements that can help design science dissemination strategies.


Subject(s)
Pandemics , Brazil/epidemiology , Child , Humans , Perception
8.
J Bras Pneumol ; 47(2): e20210044, 2021.
Article in English, Portuguese | MEDLINE | ID: mdl-33950095

ABSTRACT

On April 1st, 2020, COVID-19 surpassed tuberculosis regarding the number of deaths per day worldwide. The combination of tuberculosis and COVID-19 has great potential for morbidity and mortality. In addition, the COVID-19 pandemic has had a significant impact on the diagnosis and treatment of tuberculosis. In this review article, we address concurrent tuberculosis and COVID-19, with particular regard to the differences between Brazil and Europe. In addition, we discuss priorities in clinical care, public health, and research.


Subject(s)
Tuberculosis , Brazil/epidemiology , Europe/epidemiology , Humans , Pandemics , Tuberculosis/diagnosis , Tuberculosis/drug therapy , Tuberculosis/epidemiology
9.
Rev Soc Bras Med Trop ; 54: e0014 2021, 2021.
Article in English | MEDLINE | ID: mdl-33950121

ABSTRACT

INTRODUCTION: Severe acute respiratory syndrome coronavirus 2 has infected more than 9,834,513 Brazilians up to February 2021. Knowledge of risk factors of coronavirus disease among Brazilians remains scarce, especially in the adult population. This study verified the risk factors for intensive care unit admission and mortality for coronavirus disease among 20-59-year-old Brazilians. METHODS: A Brazilian database on respiratory illness was analyzed on October 9, 2020, to gather data on age, sex, ethnicity, education, housing area, and comorbidities (cardiovascular disease, diabetes, and obesity). Multivariate logistic regression analysis was performed to identify the risk factors for coronavirus disease. RESULTS: Overall, 1,048,575 persons were tested for coronavirus disease; among them, 43,662 were admitted to the intensive care unit, and 34,704 patients died. Male sex (odds ratio=1.235 and 1.193), obesity (odds ratio=1.941 and 1.889), living in rural areas (odds ratio=0.855 and 1.337), and peri-urban areas (odds ratio=1.253 and 1.577) were predictors of intensive care unit admission and mortality, respectively. Cardiovascular disease (odds ratio=1.552) was a risk factor for intensive care unit admission. Indigenous people had reduced chances (odds ratio=0.724) for intensive care unit admission, and black, mixed, East Asian, and indigenous ethnicity (odds ratio=1.756, 1.564, 1.679, and 1.613, respectively) were risk factors for mortality. CONCLUSIONS: Risk factors for intensive care unit admission and mortality among adult Brazilians were higher in men, obese individuals, and non-urban areas. Obesity was the strongest risk factor for intensive care unit admission and mortality.


Subject(s)
Critical Illness , Adult , Brazil/epidemiology , Hospitalization , Humans , Intensive Care Units , Male , Middle Aged , Risk Factors , Young Adult
10.
Rev Soc Bras Med Trop ; 54: e0858 2020, 2021.
Article in English | MEDLINE | ID: mdl-33950131

ABSTRACT

INTRODUCTION: Mantis shrimps or siriboias are crustaceans belonging to the order Stomatopoda. They are known for their strong claws, which they use for defense and capturing their prey. They are classified into two groups: the spearers, which pierce the prey with sharp projections, and the smashers, which strike their prey with high-powered punches. These animals are highly feared by fishermen, and there are frequent anecdotal reports of human injuries caused by these crustaceans. METHODS: A questionnaire about injuries in humans caused by these stomatopods was administered to 23 fishermen of Colony Z10 in Ubatuba, São Paulo state, Brazil, and a survey of the literature on injuries in humans caused by these animals was carried out. RESULTS: The fishermen consider the mantis shrimp dangerous and avoid direct contact with them on account of the associated risk. We describe five reports of human injuries caused by these animals: four by the claws and one by the tail spikes. CONCLUSIONS: We describe the first aid treatment, prevention, and recommendations for such cases and propose the distribution of educational leaflets among the fishermen colonies.


Subject(s)
Crustacea , Animals , Brazil/epidemiology , Humans
11.
Rev Bras Epidemiol ; 24: e210009, 2021.
Article in Portuguese, English | MEDLINE | ID: mdl-33950138

ABSTRACT

OBJECTIVE: To compare lifestyle changes during the COVID-19 pandemic according to the presence or absence of noncommunicable diseases (NCDs) in Brazilian adults. METHODS: Cross-sectional study, using data from the ConVid survey, between April and May 2020. The following variables were evaluated: lifestyle and presence of one or more NCDs (diabetes, hypertension, respiratory disease, heart disease, and cancer). Sociodemographic characteristics were used as adjustment. Relative frequencies and confidence intervals (CI) of 95% of the explanatory variables were calculated before and during the pandemic. For the comparison of groups, with or without NCDs, crude and adjusted (PRadj) prevalence ratios were estimated by Poisson regression. RESULTS: There was a reduction in physical activity (60% in those without NCDs and 58% in those with NCDs) and in vegetable consumption (10.8% in those without NCDs and 12.7% in those with NCDs). On the other hand, there was an increase in the time spent watching television and on screens of computer/tablet (302% and 43.5% in those without NCDs and 196.5% and 30.6% with NCDs, respectively); consumption of frozen meals (43.6% in those without NCDs and 53.7% with NCDs), snacks (42.3% without NCDs and 31.2% with NCDs), and chocolate (14.8% without NCDs). During the pandemic, patients with NCDs were less active (PRadj = 0.77; 95%CI 0.65 - 0.92), had greater habit of watching TV (PRadj = 1.16; 95%CI 1.08 - 1.26), and consumed less vegetables (PRadj = 0.88; 95%CI 0.81 - 0.96). CONCLUSION: It was evident that adults with NCDs had their lifestyles more altered during the COVID-19 pandemic.


Subject(s)
Noncommunicable Diseases , Adult , Brazil/epidemiology , Cross-Sectional Studies , Humans , Life Style , Noncommunicable Diseases/epidemiology , Pandemics
12.
Rev Bras Epidemiol ; 24: e210017, 2021.
Article in English | MEDLINE | ID: mdl-33950139

ABSTRACT

OBJECTIVE: To compare social characteristics, risk behaviors, and sexually transmitted infections among travestis and transsexual women. METHODOLOGY: A cross-sectional study was carried out in three cities in Goiás, Central Brazil. Trans women were interviewed on sociodemographic characteristics, discrimination, prejudice, sexual behavior, illicit drugs, and previous testing for HIV and syphilis between April 2018 and August 2019. RESULTS: A total of 166 travestis and 249 transsexual women were investigated. Although sexual, physical, and verbal violence were common to both groups, sexual behavior, use of illicit drugs, prison, and previous positive HIV and syphilis testing were more frequent among travestis than in transsexual women. CONCLUSION: The present findings confirm that Brazilian travestis are at greater risk for sexually transmitted infections (STI), indicating that health services should take this imbalance into account in terms of health intervention proportions.


Subject(s)
HIV Infections , Sexually Transmitted Diseases , Brazil/epidemiology , Cross-Sectional Studies , Female , Humans , Sexual Behavior , Sexually Transmitted Diseases/epidemiology
13.
Rev Bras Epidemiol ; 24: e210023, 2021.
Article in Portuguese, English | MEDLINE | ID: mdl-33950141

ABSTRACT

OBJECTIVE: To evaluate the association between the co-occurrence of risk behaviors (RB) and the family context in Brazilian adolescents. METHODS: Cross-sectional study on 101,534 students from the 9th grade of elementary school in the National Survey of School Health - PeNSE 2015. The co-occurrence of RB was estimated by the sum of the presence of sedentary behavior, low fruit consumption, regular consumption of alcohol and tobacco. Prevalence was assessed using the Venn diagram and multivariate analysis by the ordinal logistic regression model of partial proportional odds. RESULTS: 8.8% of the adolescents did not have RB; 34.5% had one; 42.7% had two; and 14.1%, three or four. The most prevalent combinations were between sedentary behavior and low fruit consumption (33.8%); sedentary behavior with low fruit consumption and regular consumption of alcohol (9.5%). Those who were more likely to present co-occurrence had mothers with higher education level in all models, did not live with their fathers [0, 1 and 2 vs. 3: (OR = 1.21; 95%CI 1.07-1.37)], had parents who sometimes, never or rarely understood their problems and concerns [0, 1 and 2 vs. 3: (OR = 1.62; 95%CI 1.49-1.76)] and monitored their homework [0, 1 and 2 vs. 3: (OR = 1.77; 95%CI 1.62-1.93)]; and had meals with parents or guardians <4 days/week for the three models. CONCLUSION: Health RB tend to cluster among Brazilian adolescents and are related to characteristics of the family context. These findings point to the need for health promotion actions focusing on simultaneity and not in isolation.


Subject(s)
Adolescent Behavior , Health Risk Behaviors , Adolescent , Brazil/epidemiology , Cross-Sectional Studies , Health Surveys , Humans , Schools , Socioeconomic Factors
14.
Dis Aquat Organ ; 144: 133-142, 2021 May 06.
Article in English | MEDLINE | ID: mdl-33955851

ABSTRACT

Complex interactions among hosts, pathogens, and the environment affect the vulnerability of amphibians to the emergence of infectious diseases such as chytridiomycosis, caused by Batrachochytrium dendrobatidis (Bd). Boana curupi is a forest-dwelling amphibian endemic to the southern Atlantic Forest of South America, a severely fragmented region. Here, we evaluated whether abiotic factors (including air and water temperature, relative air humidity, and landscape) are correlated with chytrid infection intensity and prevalence in B. curupi. We found individuals infected with Bd in all populations sampled. Prevalence ranged from 25-86%, and the infection burden ranged from 1 to over 130000 zoospore genomic equivalents (g.e.) (mean ± SD: 4913 ± 18081 g.e.). The infection load differed among populations and was influenced by forest cover at scales of 100, 500, and 1000 m, with the highest infection rates recorded in areas with a higher proportion of forest cover. Our results suggest that the fungus is widely distributed in the populations of B. curupi in southern Brazil. Population and disease monitoring are necessary to better understand the relationships between host, pathogen, and environment, especially when, as in the case of B. curupi, threatened species are involved.


Subject(s)
Chytridiomycota , Mycoses , Amphibians , Animals , Anura , Brazil/epidemiology , Forests , Mycoses/epidemiology , Mycoses/veterinary
17.
Front Public Health ; 9: 581618, 2021.
Article in English | MEDLINE | ID: mdl-33791265

ABSTRACT

Information on how coronavirus disease 2019 (COVID-19) mortality is related to population characteristics in low- and middle-income countries is still limited. We described the deaths from COVID-19 in Sergipe state, Northeast Brazil, from April 2 to June 27, 2020. For this purpose, we conducted a study composed of (i) a case series study of all deaths due to COVID-19 and (ii) a population-based study to verify the behavior of the mortality and case-fatality rates (CFR) related to COVID-19. Data from 605 deaths due to COVID-19 were used to describe the characteristics of individuals with the disease, as well as the differences in gender, age, and comorbidities. Additionally, population data were extracted to estimate the mortality and CFR by population stratum. We also performed an adjusted CFR analysis including a time lag of 14 days between the onset of symptoms and reporting deaths. Of the 605 patients included in this study, 321 (53.1%) were males and the median age was 67.0 years. Most patients (n = 447, 73.9%) who died from COVID-19 had at least one pre-existing clinical condition. The mortality rate was 29.3 deaths per 100,000 inhabitants and the crude CRF was 2.6% (95% CI 2.4-2.8). CFR was higher in males (3.1%, 95% CI 2.8-3.4; p < 0.001) and people aged ≥60 years (14.2%, 95% CI 13.0-15.6; p = 0.042). About 25% of patients died during the first 24-h post-hospital admission. The adjusted CFR for a 14-day time lag was ~2-fold higher than the crude CFR over the study period.


Subject(s)
/mortality , Adolescent , Adult , Aged , Brazil/epidemiology , Child , Child, Preschool , Comorbidity , Female , Humans , Infant , Infant, Newborn , Male , Middle Aged , Preexisting Condition Coverage , Young Adult
18.
Epidemiol Infect ; 149: e100, 2021 04 23.
Article in English | MEDLINE | ID: mdl-33888169

ABSTRACT

Brazil ranks second in the number of confirmed cases of COVID-19 worldwide. In spite of this, coping measures differ throughout the national territory, as does the disease's impact on the population. This cross-sectional observational study, with 59 695 cases of COVID-19 registered in the state of Alagoas between March and August 2020, analysed clinical-epidemiological variables, incidence rate, mortality rate, case fatality rate (CFR) and the social indicators municipal human development index (MHDI) and social vulnerability index (SVI). Moran statistics and regression models were applied. Logistic regression analysis was applied to determine the predictors of death. The incidence rate was 1788.7/100 000 inhabitants; mortality rate was 48.0/100 000 and CFR was 2.7%. The highest incidence rates were observed in municipalities with better human development (overall MHDI (I = 0.1668; p = 0.002), education MHDI (I = 0.1649; p = 0.002) and income MHDI (I = 0.1880; p = 0.005)) and higher social vulnerability (overall SVI (I = 0.0599; p = 0.033)). CFR was associated with higher social vulnerability (SVI human capital (I = 0.0858; p = 0.004) and SVI urban infrastructure (I = 0.0985; p = 0.040)). Of the analysed cases, 55.4% were female; 2/3 were Black or Brown and the median age was 41 years. Among deaths, most were male (919; 57.4%) and elderly (1171; 73.1%). The predictors of death were male sex, advanced age and the presence of comorbidities. In Alagoas, Brazil, the disease has undergone a process of interiorisation and caused more deaths in poorer municipalities. The presence of comorbidities and advanced age were predictors of death.


Subject(s)
/epidemiology , Adult , Aged , Brazil/epidemiology , Cross-Sectional Studies , Databases, Factual , Female , Humans , Incidence , Logistic Models , Male , Middle Aged , Registries , Risk Factors , Spatial Analysis , Young Adult
19.
Eur Rev Med Pharmacol Sci ; 25(8): 3365-3374, 2021 Apr.
Article in English | MEDLINE | ID: mdl-33928624

ABSTRACT

OBJECTIVE: Healthcare workers are at risk for COVID-19 contamination. It is important to protect them in order to reduce nosocomial transmission and maintain the assistance capacity of health systems. To evaluate the diagnostic test and retest strategy with RT-PCR for SARS-CoV-2 and factors associated with the diagnosis of COVID-19 among healthcare workers. PATIENTS AND METHODS: Cross-sectional study carried out in a Brazilian hospital. From April 27 to June 16, 2020, symptomatic healthcare workers underwent an RT-PCR test on upper respiratory tract specimens as soon as possible and, if negative, it was repeated close to the 5th day of symptom evolution. Working areas were divided into assistance areas dedicated or not dedicated to COVID-19 and non-assistance areas. The type of activity was divided into assistance or non-assistance activity. RESULTS: 775 individuals were evaluated. 114 were diagnosed with COVID-19, of whom 101 followed the testing protocol. A second RT-PCR identified five (4.9%) of the positive cases. Working in an area dedicated to patients with COVID-19 was more prevalent among positive cases (35.1% x 19.8%, p=0.001) as well as working in an assistance activity (80.7% x 70.8%, p=0.031). CONCLUSIONS: A second RT-PCR test after the 5th day of symptom evolution showed limited diagnostic improvement. The adoption of a single test-based strategy, carried out at the right time after the onset of symptoms, allows the optimal use of resources. Working in a COVID-19 dedicated area and in direct contact with patients is related to a higher prevalence of COVID-19 among symptomatic healthcare workers.


Subject(s)
/methods , Health Personnel , Adult , Brazil/epidemiology , /physiopathology , Disease Progression , Female , Humans , Infectious Disease Transmission, Patient-to-Professional , Male , Middle Aged , Prevalence , Time Factors
20.
JAMA Netw Open ; 4(4): e216468, 2021 04 01.
Article in English | MEDLINE | ID: mdl-33885775

ABSTRACT

Importance: Data on the efficacy of hydroxychloroquine or lopinavir-ritonavir for the treatment of high-risk outpatients with COVID-19 in developing countries are needed. Objective: To determine whether hydroxychloroquine or lopinavir-ritonavir reduces hospitalization among high-risk patients with early symptomatic COVID-19 in an outpatient setting. Design, Setting, and Participants: This randomized clinical trial was conducted in Brazil. Recently symptomatic adults diagnosed with respiratory symptoms from SARS-CoV-2 infection were enrolled between June 2 and September 30, 2020. The planned sample size was 1476 patients, with interim analyses planned after 500 patients were enrolled. The trial was stopped after the interim analysis for futility with a sample size of 685 patients. Statistical analysis was performed in December 2020. Interventions: Patients were randomly assigned to hydroxychloroquine (800 mg loading dose, then 400 mg daily for 9 days), lopinavir-ritonavir (loading dose of 800 mg and 200 mg, respectively, every 12 hours followed by 400 mg and 100 mg, respectively, every 12 hours for the next 9 days), or placebo. Main Outcomes and Measures: The primary outcomes were COVID-19-associated hospitalization and death assessed at 90 days after randomization. COVID-19-associated hospitalization was analyzed with a Cox proportional hazards model. The trial included the following secondary outcomes: all-cause hospitalization, viral clearance, symptom resolution, and adverse events. Results: Of 685 participants, 632 (92.3%) self-identified as mixed-race, 377 (55.0%) were women, and the median (range) age was 53 (18-94) years. A total of 214 participants were randomized to hydroxychloroquine; 244, lopinavir-ritonavir; and 227, placebo. At first interim analysis, the data safety monitoring board recommended stopping enrollment of both hydroxychloroquine and lopinavir-ritonavir groups because of futility. The proportion of patients hospitalized for COVID-19 was 3.7% (8 participants) in the hydroxychloroquine group, 5.7% (14 participants) in the lopinavir-ritonavir group, and 4.8% (11 participants) in the placebo group. We found no significant differences between interventions for COVID-19-associated hospitalization (hydroxychloroquine: hazard ratio [HR], 0.76 [95% CI, 0.30-1.88]; lopinavir-ritonavir: HR, 1.16 [95% CI, 0.53-2.56] as well as for the secondary outcome of viral clearance through day 14 (hydroxychloroquine: odds ratio [OR], 0.91 [95% CI, 0.82-1.02]; lopinavir-ritonavir: OR, 1.04 [95% CI, 0.94-1.16]). At the end of the trial, there were 3 fatalities recorded, 1 in the placebo group and 2 in the lopinavir-ritonavir intervention group. Conclusions and Relevance: In this randomized clinical trial, neither hydroxychloroquine nor lopinavir-ritonavir showed any significant benefit for decreasing COVID-19-associated hospitalization or other secondary clinical outcomes. This trial suggests that expedient clinical trials can be implemented in low-income settings even during the COVID-19 pandemic. Trial Registration: ClinicalTrials.gov Identifier: NCT04403100.


Subject(s)
Early Medical Intervention , Hydroxychloroquine/administration & dosage , Lopinavir/administration & dosage , Ritonavir/administration & dosage , Antiviral Agents/administration & dosage , Brazil/epidemiology , /therapy , Drug Monitoring/methods , Drug Monitoring/statistics & numerical data , Drug Therapy, Combination/methods , Early Medical Intervention/methods , Early Medical Intervention/statistics & numerical data , Female , Hospitalization/statistics & numerical data , Humans , Male , Medical Futility , Middle Aged , Risk Adjustment/methods , Symptom Assessment/methods , Treatment Outcome
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