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1.
researchsquare; 2024.
Preprint in English | PREPRINT-RESEARCHSQUARE | ID: ppzbmed-10.21203.rs.3.rs-4183594.v1

ABSTRACT

Background: The COVID-19 pandemic brought about sudden changes in healthcare demands, necessitating additional healthcare professionals and altering the educational landscape for medical and nursing residents. This study aimed to explore the experiences and impact of the pandemic on the training of family and community medicine as well as family and community nursing residents. Method: A participatory qualitative study was conducted using the Photovoice methodology. Seven residents in family and community medicine and nursing in the Madrid region were purposively sampled. Participants took photographs and engaged in weekly sessions over five weeks to discuss and analyse their photos, which were grouped into themes and further categorized. Recommendations for institutions and program leaders were developed using an adapted logical framework approach. Results: The average age was 27 years, with 86% being female. Participants captured 96 photographs categorized into five themes (physical and emotional impact;  impact on primary care system;  hospital care ; social and environmental impact ; and impact on training). Through critical discussions on impact on training-related photos, seven emergent themes were identified: 1) COVID-19 monograph, buried knowledge;  2) Changing roles ; 3) Transition from face-to-face to online delivery format ; 4) Supervision; 5) Tutor as educator and caregiver ; 6) Advocacy ;  7) Family and nursing residents as agents of change. Subsequently, participants formulated seven recommendations that should be considered in similar situations. Conclusion: The COVID-19 pandemic has posed significant challenges in implementing medical education programs. It has had both formative and professional impacts on medical and nursing residents. These findings can aid in designing coping and educational strategies to navigate exceptional situations such as the one experienced during the pandemic.


Subject(s)
COVID-19
2.
Eur J Cancer ; 185: 178-215, 2023 05.
Article in English | MEDLINE | ID: covidwho-2260665

ABSTRACT

BACKGROUND: Innovations in imaging and molecular characterisation together with novel treatment options have improved outcomes in advanced prostate cancer. However, we still lack high-level evidence in many areas relevant to making management decisions in daily clinical practise. The 2022 Advanced Prostate Cancer Consensus Conference (APCCC 2022) addressed some questions in these areas to supplement guidelines that mostly are based on level 1 evidence. OBJECTIVE: To present the voting results of the APCCC 2022. DESIGN, SETTING, AND PARTICIPANTS: The experts voted on controversial questions where high-level evidence is mostly lacking: locally advanced prostate cancer; biochemical recurrence after local treatment; metastatic hormone-sensitive, non-metastatic, and metastatic castration-resistant prostate cancer; oligometastatic prostate cancer; and managing side effects of hormonal therapy. A panel of 105 international prostate cancer experts voted on the consensus questions. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The panel voted on 198 pre-defined questions, which were developed by 117 voting and non-voting panel members prior to the conference following a modified Delphi process. A total of 116 questions on metastatic and/or castration-resistant prostate cancer are discussed in this manuscript. In 2022, the voting was done by a web-based survey because of COVID-19 restrictions. RESULTS AND LIMITATIONS: The voting reflects the expert opinion of these panellists and did not incorporate a standard literature review or formal meta-analysis. The answer options for the consensus questions received varying degrees of support from panellists, as reflected in this article and the detailed voting results are reported in the supplementary material. We report here on topics in metastatic, hormone-sensitive prostate cancer (mHSPC), non-metastatic, castration-resistant prostate cancer (nmCRPC), metastatic castration-resistant prostate cancer (mCRPC), and oligometastatic and oligoprogressive prostate cancer. CONCLUSIONS: These voting results in four specific areas from a panel of experts in advanced prostate cancer can help clinicians and patients navigate controversial areas of management for which high-level evidence is scant or conflicting and can help research funders and policy makers identify information gaps and consider what areas to explore further. However, diagnostic and treatment decisions always have to be individualised based on patient characteristics, including the extent and location of disease, prior treatment(s), co-morbidities, patient preferences, and treatment recommendations and should also incorporate current and emerging clinical evidence and logistic and economic factors. Enrolment in clinical trials is strongly encouraged. Importantly, APCCC 2022 once again identified important gaps where there is non-consensus and that merit evaluation in specifically designed trials. PATIENT SUMMARY: The Advanced Prostate Cancer Consensus Conference (APCCC) provides a forum to discuss and debate current diagnostic and treatment options for patients with advanced prostate cancer. The conference aims to share the knowledge of international experts in prostate cancer with healthcare providers worldwide. At each APCCC, an expert panel votes on pre-defined questions that target the most clinically relevant areas of advanced prostate cancer treatment for which there are gaps in knowledge. The results of the voting provide a practical guide to help clinicians discuss therapeutic options with patients and their relatives as part of shared and multidisciplinary decision-making. This report focuses on the advanced setting, covering metastatic hormone-sensitive prostate cancer and both non-metastatic and metastatic castration-resistant prostate cancer. TWITTER SUMMARY: Report of the results of APCCC 2022 for the following topics: mHSPC, nmCRPC, mCRPC, and oligometastatic prostate cancer. TAKE-HOME MESSAGE: At APCCC 2022, clinically important questions in the management of advanced prostate cancer management were identified and discussed, and experts voted on pre-defined consensus questions. The report of the results for metastatic and/or castration-resistant prostate cancer is summarised here.


Subject(s)
COVID-19 , Prostatic Neoplasms, Castration-Resistant , Male , Humans , Prostatic Neoplasms, Castration-Resistant/pathology , Diagnostic Imaging , Hormones
3.
Am J Community Psychol ; 71(1-2): 136-146, 2023 03.
Article in English | MEDLINE | ID: covidwho-2172355

ABSTRACT

The COVID-19 pandemic and violence against people of Color during 2020 brought troubling racial inequities to the forefront of American discourse. In line with the Critical Consciousness (CC) and Social Justice Youth Development (SJYD) frameworks, emerging adults may have developed their capacity for critical reflection, motivation, and action against systemic inequities. We drew from interviews with 27 emerging adults (ages 18-23) across the US, and used thematic analysis to explore differences in their reflections, motivations to act, and actions based on their racial/ethnic identification. We found nuanced variability in their critical reflections based on self, social, or global awareness and experiences of marginalization. White and Asian emerging adults used vague language or expressed feeling their reflections were insufficient. Black and Latinx emerging adults emphasized the importance of education and raising awareness. Although all emerging adults took action based on a sense of duty, few engaged in critical action; decisions to take in-person action varied based on whether they viewed racism or COVID-19 as a greater threat. Findings demonstrate that emerging adults' experiences of racialization may have related to their CC development. We share implications for community psychologists conducting antiracist research addressing White fragility and dismantling racial hierarchy.


Subject(s)
COVID-19 , Racism , Adolescent , Adult , Humans , Young Adult , Black or African American , Consciousness , Pandemics , Racial Groups , United States , White , Asian , Hispanic or Latino
4.
Vaccines (Basel) ; 10(11)2022 Nov 15.
Article in English | MEDLINE | ID: covidwho-2116140

ABSTRACT

COVID-19 is associated with poor maternal and pregnancy outcomes. COVID-19 vaccination is recommended in Spain, yet vaccination rates in pregnancy are suboptimal. This study investigates the perceptions of pregnant women and healthcare workers (HCW) regarding COVID-19 vaccination. A web-based cross-sectional quantitative study was conducted in 2021-2022 among 302 pregnant women and 309 HCWs in the Catalan public health system. Most pregnant women (83%) and HCWs (86%) were aware of COVID-19 maternal vaccines. The recommendation of the COVID-19 vaccination by an HCW was identified as the greatest facilitator for maternal vaccine uptake, while the fear of harming the foetus was the most significant barrier reported for rejecting vaccination. HCWs recognised they received limited information and training about COVID-19 vaccination in pregnancy, which hindered them from providing informed recommendations. This study highlights that information and education on COVID-19 vaccines to pregnant women and health professionals are pivotal to ensuring informed decision-making and increasing vaccine uptake.

5.
Vaccines (Basel) ; 10(12)2022 Nov 25.
Article in English | MEDLINE | ID: covidwho-2123922

ABSTRACT

The World Health Organization (WHO) identified vaccine hesitancy as one of the top 10 threats to global health in 2019. Health promotion and education have been seen to improve knowledge and uptake of vaccinations in pregnancy. This qualitative study was conducted based on phenomenology, a methodological approach to understand first-hand experiences, and grounded theory, an inductive approach to analyse data, where theoretical generalisations emerge. Data were collected through semi-structured interviews with pregnant women attending antenatal care services and healthcare workers (HCWs) in Barcelona, Spain. Interviews were audio-recorded, transcribed, and coded, and notes were taken. Inductive thematic analysis was performed, and data were manually coded. Pertussis was reported as the most trusted vaccine among pregnant women due to its long-standing background as a recommended vaccine in pregnancy. The influenza vaccine was regarded as less important since it was perceived to cause mild disease. The COVID-19 vaccine was the least trustworthy for pregnant women due to uncertainties about effectiveness, health effects in the mid- and long-term, the fast development of the vaccine mRNA technology, and the perceptions of limited data on vaccine safety. However, the necessity to be vaccinated was justified by pregnant women due to the exceptional circumstances of the COVID-19 pandemic. The recommendations provided by HCW and the established relationship between the HCW, particularly midwives, and pregnant women were the main factors affecting decision-making. The role of mass media was perceived as key to helping provide reliable messages about the need for vaccines during pregnancy. Overall, vaccines administered during pregnancy were perceived as great tools associated with better health and improved quality of life. Pregnancy was envisioned as a vulnerable period in women's lives that required risk-benefits assessments for decision-making about maternal vaccinations. A holistic approach involving the community and society was considered crucial for health education regarding maternal vaccines in support of the work conducted by HCWs.

6.
Exp Gerontol ; 168: 111946, 2022 10 15.
Article in English | MEDLINE | ID: covidwho-2007700

ABSTRACT

Confinement due to the COVID-19 pandemic has had a major impact on the living habits and health of the population, notably in the pre-frail elderly. This study aimed to study the effect of the COVID-19 pandemic on the physical function, mental function (cognition and mood), and quality of life of pre-frail elderly individuals over 70 years of age following confinement as well as to analyze the variables associated with the observed changes. METHODS: Observational study of a cohort of pre-frail community-dwelling older adults over 70 years of age during the COVID-19 pandemic conducted in primary care. VARIABLES: The main outcome variables were recorded during face-to-face interviews between December 14 of 2020 and August 12 of 2021 using scales for the evaluation of physical function (Short Physical Performance Battery), cognition (Lobo's Mini-Examen Cognoscitivo), depressive mood (Geriatric Depression Scale), and quality of life (EuroQol-5D-3L). Covariates: sociodemographic data and variables related to the pandemic and general health (social support network, COVID-19 infection, exercising, and leisure activities) were also collected. ANALYSIS: The Student's t-test for paired samples and multivariate linear regression models were employed for the statistical analyses. RESULTS: Ninety-two subjects were included in the study. Physical function, cognition, and depressive mood improved during the pandemic, whereas no changes were observed in quality of life. Suffering from COVID-19 was associated with deterioration of the cognitive function (-1.460; CI95%: -2.710 to -0.211). CONCLUSION: Confinement due to the COVID-19 pandemic was not associated with a decline in physical function, cognition, depressive mood, or quality of life in pre-frail individuals over 70 years of age.


Subject(s)
COVID-19 , Quality of Life , Aged , Aged, 80 and over , COVID-19/epidemiology , Cognition , Cohort Studies , Cross-Sectional Studies , Depression/epidemiology , Frail Elderly/psychology , Geriatric Assessment , Humans , Longitudinal Studies , Observational Studies as Topic , Quality of Life/psychology
7.
Br J Gen Pract ; 72(720): e501-e510, 2022 07.
Article in English | MEDLINE | ID: covidwho-1924322

ABSTRACT

BACKGROUND: The COVID-19 pandemic has had a major impact on the mental health of healthcare workers, yet studies in primary care workers are scarce. AIM: To investigate the prevalence of and associated factors for psychological distress in primary care workers during the first COVID-19 outbreak. DESIGN AND SETTING: This was a multicentre, cross-sectional, web-based survey conducted in primary healthcare workers in Spain, between May and September 2020. METHOD: Healthcare workers were invited to complete a survey to evaluate sociodemographic and work-related characteristics, COVID-19 infection status, exposure to patients with COVID-19, and resilience (using the Connor-Davidson Resilience Scale), in addition to being screened for common mental disorders (depression, anxiety disorders, post-traumatic stress disorder, panic attacks, and substance use disorder). Positive screening for any of these disorders was analysed globally using the term 'any current mental disorder'. RESULTS: A total of 2928 primary care professionals participated in the survey. Of them, 43.7% (95% confidence interval [CI] = 41.9 to 45.4) tested positive for a current mental disorder. Female sex (odds ratio [OR] 1.61, 95% CI = 1.25 to 2.06), having previous mental disorders (OR 2.58, 95% CI = 2.15 to 3.10), greater occupational exposure to patients with COVID-19 (OR 2.63, 95% CI = 1.98 to 3.51), having children or dependents (OR 1.35, 95% CI = 1.04 to 1.76 and OR 1.59, 95% CI = 1.20 to 2.11, respectively), or having an administrative job (OR 2.24, 95% CI = 1.66 to 3.03) were associated with a higher risk of any current mental disorder. Personal resilience was shown to be a protective factor. CONCLUSION: Almost half of primary care workers showed significant psychological distress. Strategies to support the mental health of primary care workers are necessary, including designing psychological support and resilience-building interventions based on risk factors identified.


Subject(s)
COVID-19 , Anxiety/epidemiology , COVID-19/epidemiology , Child , Cross-Sectional Studies , Depression/epidemiology , Female , Health Personnel/psychology , Humans , Pandemics , Primary Health Care , SARS-CoV-2
8.
Gac Sanit ; 36 Suppl 1: S36-S43, 2022.
Article in Spanish | MEDLINE | ID: covidwho-1920887

ABSTRACT

The COVID-19 pandemic and the associated public health emergency have affected patients and health services in non-COVID-19 pathologies. Several studies have shown its dissociation from health services, with a decrease in emergency department visits, in hospital admissions for non-COVID-19 pathologies, as well as in the reported weekly incidence of acute illnesses and new diagnoses in primary care. In parallel, the pandemic has had direct and indirect effects on people with chronic diseases; the difficulties in accessing health services, the interruption of care, the saturation of the system itself and its reorientation towards non-face-to-face formats has reduced the capacity to prevent or control chronic diseases. All this has also had an impact on the different areas of people's lives, creating new social and economic difficulties, or aggravating those that existed before the pandemic. All these circumstances have changed with each epidemic wave. We present a review of the most relevant studies that have been analyzing this problem and incorporate as a case study the results of a retrospective observational study carried out in Primary Care in the Madrid Health Service, which provides health coverage to a population of more than 6 million people, and whose objective was to analyze the loss of new diagnoses in the most prevalent pathologies such as common mental health problems, cardiovascular and cerebrovascular diseases, type 2 diabetes, chronic obstructive pulmonary disease, and breast and colon tumors, in the first and second waves. Annual incidence rates with their confidence interval were calculated for each pathology and the monthly frequency of new codes recorded between 1/01/2020 and 12/31/2020 was compared with the monthly mean of observed counts for the same months between 2016 and 2019. The annual incidence rate for all processes studied decreased in 2020 except for anxiety disorders. Regarding the recovery of lost diagnoses, heart failure is the only diagnosis showing an above-average recovery after the first wave. To return to pre-pandemic levels of diagnosis and follow-up of non-COVID-19 pathology, the healthcare system must reorganize and contemplate specific actions for the groups at highest risk.


Subject(s)
COVID-19 , Diabetes Mellitus, Type 2 , COVID-19/diagnosis , COVID-19/epidemiology , Follow-Up Studies , Humans , Missed Diagnosis , Observational Studies as Topic , Pandemics
9.
Emerging Adulthood ; : 21676968221098296, 2022.
Article in English | Sage | ID: covidwho-1820119

ABSTRACT

The COVID-19 pandemic has had wide-ranging impacts on college-going emerging adults and their communities, which may prompt them to engage civically. Using spring 2020 survey data from a national sample of college students aged 18?22 (N = 707), we document the prevalence of pandemic-related civic engagement as well as differences in engagement by sociopolitical perspectives. The majority of participants (70.4%) reported engaging civically at least once, most commonly online (e.g., sharing information about COVID-19 on social media, volunteering virtually). Results showed differences in civic engagement by communal orientation and the candidate participants intended to vote for in the 2020 presidential election, but not by political party affiliation. Qualitative data provide insight into different motivations for pandemic-related civic engagement. We conclude that emerging adult college students? pandemic-related civic engagement is partially motivated by their sociopolitical perspectives and discuss implications for future work examining emerging adult civic engagement more broadly.

10.
Emerg Adulthood ; 10(2): 546-557, 2022 Apr.
Article in English | MEDLINE | ID: covidwho-1613213

ABSTRACT

We analyzed qualitative data from 707 USA college students aged 18-22 in late April 2020 regarding if and how their relationships had changed at the start of the COVID-19 pandemic. Most (69%) participants experienced relationship changes, most of whom (77%) described negative changes: less overall contact, feeling disconnected, and increased tension, some of which was due to conflict over pandemic-related public health precautions. Physical distancing from social contacts also created emotional distancing: it was harder to maintain affective connections via online platforms and within the isolating context of shelter-in-place. Due to emerging adulthood being a sensitive window for social development, the COVID-19 pandemic-induced emotional distancing could have long-term ramifications for this cohort's relationships over the course of their lives.

11.
Int J Environ Res Public Health ; 18(20)2021 10 13.
Article in English | MEDLINE | ID: covidwho-1470831

ABSTRACT

Participation of pregnant women in clinical trials entails challenges mainly related to concerns about the risks for fetuses. We undertook a qualitative study from June to October 2020 to assess the acceptability of participating in COVID-19 clinical trials among pregnant women in Spain. Phenomenology and grounded theory were used as methodological approaches. Semi-structured interviews were conducted with 24 pregnant women and six healthcare providers. Women were unsure if pregnancy was a risk factor to acquire the infection or to develop severe disease and expressed the limited information they had received, which led to uncertainties and emotional suffering. They had concerns regarding participation in clinical trials on COVID-19, regardless of the drug under study. Healthcare providers alluded to the importance of involving pregnant women's relatives at the recruitment visit of the clinical trial. These findings may be useful to facilitate pregnant women's participation in clinical trials.


Subject(s)
COVID-19 , Pregnant Women , Clinical Trials as Topic , Female , Health Personnel , Humans , Patient Participation , Pregnancy , Qualitative Research , SARS-CoV-2
12.
J Community Psychol ; 50(2): 760-777, 2022 Mar.
Article in English | MEDLINE | ID: covidwho-1340265

ABSTRACT

Critical consciousness (CC) may promote well-being, particularly during the COVID-19 pandemic. In a national survey of 707 college students conducted in April 2020, we first validated the Short Critical Consciousness Scale (ShoCCS) among youth groups not often specifically examined in CC measurement (i.e., Asian, immigrant-origin, LGBQ+, and women youth). Next, we examined associations between ShoCCS subscales and validated measures of both anxiety (Generalized Anxiety Disorder-7) and hopefulness (The Individual-Differences Measure in Hopefulness). The ShoCCS achieved measurement invariance across racial/ethnic groups and immigrant-origin status, and partial invariance among LGBQ+ and women-identifying youth. We found critical reflection and action associated with anxiety for the full sample, but no evidence of moderation by sociodemographic factors. ShoCCS subscales were differentially associated with hopefulness for Asian youth and LGBQ+ youth. This study contributes to the evolution of CC measurement and extends the field by identifying well-being associations during the onset of the COVID-19 pandemic.


Subject(s)
COVID-19 , Consciousness , Adolescent , Female , Humans , Pandemics , SARS-CoV-2 , Students
13.
J Adolesc Health ; 68(2): 270-276, 2021 02.
Article in English | MEDLINE | ID: covidwho-1065260

ABSTRACT

PURPOSE: The purpose of this study is to document young adults' perceived stress and anxiety in a diverse sample of college students across the U.S. during the COVID-19 pandemic. METHODS: We recruited, via Instagram, a sample of full-time college students aged 18-22 from across the U.S. We surveyed them in April (baseline; N = 707; mean age = 20.0, SD = 1.3) and July (follow-up) 2020. This study presents overall levels of perceived stress and general anxiety symptoms and inequalities across each of these outcomes by gender, sexual orientation, race/ethnicity, and household income. We also explore potential explanations for these health issues by analyzing baseline qualitative data. RESULTS: All students, on average, were suffering from perceived stress and anxiety, with especially high levels in April. We also identified inequalities in college student mental well-being, particularly by gender identity and sexual orientation. Women reported worse well-being compared with men; transgender and gender diverse and sexual minority youths reported worse outcomes than their cisgender, heterosexual peers at both time points. Qualitative data illustrate how the COVID-19 pandemic has generated educational, economic, and environmental stressors that are affecting college students' well-being. CONCLUSIONS: As colleges and universities think about how to manage and mitigate the infectious disease dimensions of COVID-19 among their student populations, they must also consider who is most at risk for increased stress and anxiety during the pandemic.


Subject(s)
Anxiety/psychology , COVID-19/psychology , Depression/psychology , Heterosexuality/statistics & numerical data , Sexual and Gender Minorities/statistics & numerical data , Adult , Ethnicity/statistics & numerical data , Female , Heterosexuality/psychology , Humans , Income/statistics & numerical data , Male , Qualitative Research , Sex Factors , Sexual and Gender Minorities/psychology , Surveys and Questionnaires , United States , Universities , Young Adult
14.
Trials ; 21(1): 607, 2020 Jul 02.
Article in English | MEDLINE | ID: covidwho-621540

ABSTRACT

OBJECTIVES: The primary objectives of the study are: 1. To assess the effect of hydroxychloroquine (HCQ) in reducing SARS-CoV-2 viral shedding by PCR in infected pregnant women with mild symptoms. 2. To assess the efficacy of HCQ to prevent SARS-CoV-2 infection in pregnant women in contact with an infected or suspected case. 3. To evaluate the effect of HCQ in preventing the development of the COVID-19 disease in asymptomatic SARS-CoV-2-infected pregnant women. The secondary objectives are: 1. To determine the effect of HCQ on the clinical course and duration of the COVID-19 disease in SARS-CoV-2-infected pregnant women. 2. To determine the impact of HCQ on the risk of hospitalization and mortality of SARS-CoV-2-infected pregnant women. 3. To assess the safety and tolerability of HCQ in pregnant women. 4. To describe the clinical presentation of SARS-CoV-2 infection during pregnancy. 5. To describe the effects of maternal SARS-CoV-2 infection on pregnancy and perinatal outcomes by treatment group. 6. To determine the risk of vertical transmission (intra-utero and intra-partum) of SARS-CoV-2. TRIAL DESIGN: Randomized double-blind placebo-controlled two-arm multicentre clinical trial to evaluate the safety and efficacy of HCQ to prevent and/or minimize SARS-CoV-2 infection during pregnancy. Participants will be randomized to receive a 14-day oral treatment course of HCQ or placebo, ratio 1:1. PARTICIPANTS: Study population: pregnant women undergoing routine prenatal follow up or attending emergency units at the participating hospitals who report either symptoms/signs suggestive of COVID-19 disease or close contact with a suspected or confirmed COVID-19 case. Inclusion criteria Women will be invited to participate in the trial and sign an informed consent if they meet the following inclusion criteria. • Presenting with fever (≥37.5°C) and/or one mild symptom suggestive of COVID-19 disease (cough, dyspnoea, chills, odynophagia, diarrhoea, muscle pain, anosmia, dysgeusia, headache) OR being contact* of a SARS-CoV-2 confirmed or suspected case in the past 14 days • More than 12 weeks of gestation (dated by ultrasonography) • Agreement to deliver in the study hospitals Exclusion criteria • Known hypersensitivity to HCQ or other 4-amonoquinoline compounds • History of retinopathy of any aetiology • Concomitant use of digoxin, cyclosporine, cimetidine • Known liver disease • Clinical history of cardiac pathology including known long QT syndrome • Unable to cooperate with the requirements of the study • Participating in other intervention studies • Delivery onset (characterized by painful uterine contractions and variable changes of the cervix, including some degree of effacement and slower progression of dilatation up to 5 cm for first and subsequent labours) The study participants will be stratified by clinical presentation and SARS-CoV-2 PCR results. Assignment of participants to study groups will be as follows: • SARS-CoV-2-PCR confirmed, infected pregnant women: a. symptomatic (n=100) b. asymptomatic (n=100) • SARS-CoV-2 PCR negative pregnant women in contact* with a SARS-CoV-2-infected confirmed or suspected case (n=514). *The ECDC definition of close contact will be followed. The trial will be conducted in five hospitals in Spain: Hospital Clínic of Barcelona, Hospital Sant Joan de Déu and Hospital de la Santa Creu i Sant Pau, in Barcelona, and HM Puerta del Sur and Hospital Universitario de Torrejón, in Madrid. INTERVENTION AND COMPARATOR: Participants will be randomized to HCQ (400 mg/day for three days, followed by 200 mg/day for 11 days) or placebo (2 tablets for three days, followed by one tablet for 11 days). MAIN OUTCOMES: The primary outcome is the number of PCR-confirmed infected pregnant women assessed from collected nasopharyngeal and oropharyngeal swabs at day 21 after treatment start (one week after treatment is completed). RANDOMISATION: Allocation of participants to study arms will be done centrally by the trial's Sponsor (the Barcelona Institute for Global Health, ISGlobal) by block randomization. This method will ensure balanced allocation to both arms. The electronic CRF will automatically assign a study number to each participant, depending on her study group and recruitment site. Each number will be related to a treatment number, which assigns them to one of the study arms. BLINDING (MASKING): Participants, caregivers, investigators and those assessing the outcomes will be blinded to group assignment. Study tablets (HCQ and placebo) will be identically packaged in small opaque bottles. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): This study requires 200 SARS-CoV-2 infected and 514 contact pregnant women, randomised 1:1 with 100 and 227 respectively in each study arm. TRIAL STATUS: Protocol version 1.0, from May 8th, 2020. Recruitment is ongoing (first patient recruited the 19th May 2020 and recruitment end anticipated by December 2020). TRIAL REGISTRATION: EudraCT number: 2020-001587-29, registered 2 April 2020. Clinicaltrials.gov identifier: NCT04410562 , retrospectively registered 1 June 2020. FULL PROTOCOL: 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.


Subject(s)
Antiviral Agents/administration & dosage , Betacoronavirus/drug effects , Chemoprevention , Coronavirus Infections/prevention & control , Hydroxychloroquine/administration & dosage , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Pregnancy Complications, Infectious/prevention & control , Antiviral Agents/adverse effects , Antiviral Agents/pharmacokinetics , Betacoronavirus/pathogenicity , COVID-19 , Coronavirus Infections/diagnosis , Coronavirus Infections/drug therapy , Coronavirus Infections/mortality , Coronavirus Infections/virology , Double-Blind Method , Drug Administration Schedule , Female , Host-Pathogen Interactions , Humans , Hydroxychloroquine/adverse effects , Hydroxychloroquine/pharmacokinetics , Multicenter Studies as Topic , Pneumonia, Viral/diagnosis , Pneumonia, Viral/mortality , Pneumonia, Viral/virology , Pregnancy , Pregnancy Complications, Infectious/diagnosis , Pregnancy Complications, Infectious/mortality , Pregnancy Complications, Infectious/virology , Protective Factors , Randomized Controlled Trials as Topic , Risk Assessment , Risk Factors , SARS-CoV-2 , Severity of Illness Index , Spain , Time Factors , Treatment Outcome , Virus Shedding/drug effects , COVID-19 Drug Treatment
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